9 & 10 September 2020

LYON - Matmut Stadium

8th edition

EXHIBITORS IN 2020

3D MEDLAB

www.3d-medlab.com

Activity : 3D-Medlab is an engineering office specialized in supporting health professionals in the mastery of additive manufacturing. Our activity is exclusively dedicated to the development of 3D printing in the medical field. Our team have also a good background in aerospace. Our Business is mainly focused on 3 sectors: Industrial (manufacturers of medical devices, to develop new product lines by additive manufacturing or to be supported in the development of their 3D printing activity), Hospitals (simulations center, surgeons and health establishments wishing to integrate additive technology into their structure: to develop anatomical models, customized cutting guides, adapted and / or disposable instruments, customized implants), R&D: Research and studies of new materials and 3D manufacturing processes for the development of innovative and futuristic medical devices.

 

Innovation : New medical simulators development with biomimetic characters through new 3D printing technology. Nitinol 3D study in new cardio and neurovascualary devices development. Development of a device to replace the intervertebral disc by 3D printing means. Complete methodology for the creation and design of a patient-dependent implant optimized from a mechanobiological point of view

3D-Side 

www.3dside.eu

Activity : 3D-Side is a medical technology company which took up the challenge to link surgeons to 3D technology. Thanks to 3D software, additive manufacturing and strong knowledge of the surgical field, 3D-Side set up a complete ISO13485 workflow to plan complex interventions and provide surgeons with cranial implants or advanced solutions for bone surgery.

 

Innovation : Patient specific implants - Planning software.

ACTRONIKA

https://actronika.com

Activity : Actronika offers haptic solutions that enable touch functions to be incorporated into human-machine interfaces. Our technology enables users to receive information (in addition to sight and hearing) and improve human-machine interactions in the medical industry. Our haptic solutions can also be considered as treatment. For example, we can imagine prostheses equipped with our technology that would allow amputees to regain a certain sense of touch.

AEM VAYRAC

www.aem-vayrac.fr

Activity : AEM is a French company located in the Lot. Around its core business, electromechanics, AEM has developed a network of complementary skills : Connectors subassembly - Integration and testing of electromechanical subassembly - Electrical and ultrasonic compaction (1 to 25 mm²) - Low pressure (Hot Melt) and high pressure (PU / PA / TPE) overmoulding - Overmoulding and sealing cables connectors and printed circuit - Enclosures and cabinets wiring - Machine design and automation for all types of overmoulding and technical bonding. We work in partnership with major contractors for the study and industrialization of specific products: electrical equipment manufacturers or subcontractors in automotive, medical, aeronautical and military and agricultural fields. All our customers recognize and certify our know-how.

 

AEMtec

https://www.aemtec.com/

Activity : AEMtec is a global acting specialist for the development and production of a variety of precision optoelectronic products, including components, subsystems, modules and complete systems. AEMtec provides a wide technology portfolio including Wafer Back-End Services, Chip on Board, Flip Chip, 3D Integration and Opto Packaging- the right partner for complex and reliable solutions in the sector of miniaturization. Long experience means customized solutions for Med Tech like X-Ray Imaging, Laboratory Diagnostic Systems, Endoscospes and Short Term Implants. 
 

AERIAL

www.aerial-crt.com

 

Activity : Aerial is a multidisciplinary technological resource centre that uses several irradiation platforms for treatment with low, medium or high energy electrons or x-rays. The flexibility of the experimental conditions of these equipments, combined with integrated labs (accredited dosimetry, Microbiology, physical chemistry, NMR) with high-performance analytical tools, allows Aerial's team to offer a set of services perfectly adapted to the development of new processes and their transfer to industry. Among the most well-known industrial uses is the sterilization of medical devices where the lethal effect of ionizing radiation on microorganisms is used.

 

Innovation : Aerial Dosimetry Laboratory is COFRAC accredited: Calibration: Accreditation N ° 1-1833 - Tests: accreditation N ° 2-1564. Only laboratory in France approved by the DGCCRF for the detection of foods treated with ionization

 

AKTEHOM-EXPLEO

www.aktehom.comwww.expleogroup.com

ActivityConsulting services for the Healthcare Industry, Technologies, R&D, Engineering, Quality, Regulatory Affairs, Manufacturing & Supply Chain, Audit & Strategy, Project Management, Training, Change Management.

ALBHADES

www.albhades.com

 

Activity : As an analytical service provider, we meet your analytical needs to validate the efficiency and quality of your processes : cleaning validation: implants (according to ISO 19227) and surgical instruments (AAMI TIR 12, AAMI TIR30, ISO 17665), packaging validation: accelerated aging and tests according to ISO 11607, sterilizing dose justification: verification and dose audit according to ISO 11137, biocompatibility according to ISO 10993-1, 10993-5, 10993-12 and chemical characterization according to ISO 10993-18

 

Innovation : First laboratory certified on ISO 13485 accredited ISO 17025 on ISO 10993-12 & ISO

ALCYM

www.alcym.fr

Activity : Design engineering company capable of handling your future product development in mechatronics. ALCYM combines versatile skills and experience for instance in Mechanics, Electronics, Software and is capable of handling your future Product Development according to all prescriptions, including Prototyping, Verification and Manufacturing.  Familiar with Medical Environment and relevant Quality requirements, ALCYM is competent to properly conduct the design of your future Medical Device and support Prototyping and possibly Production via its outstanding partners.

ALL CIRCUITS

www.allcircuits.com

 

Activity : The world of health is taking advantage of the evolution of medical techniques and available technologies to allow a reduction in hospitalization time and medical follow-up at home. ALL Circuits answers these new challenges by relying on a recognized expertise and adapted solutions. As a generalist EMS highly exposed to the automotive and industrial sectors, ALL Circuits has developed its services with recognized actors of the medical sector. Specialized in the industrialization and manufacturing of high quality electronic solutions using highly automated lines, we offer a competitive & tailor-made service from the design phase through to the analysis of customer field returns. From the electronic board (PCBA) through to complete and certified sub-assemblies and products, manufacturers and major market players trust ALL Circuits.

Innovation : Coating process for electronic boards, Potting for electronic boards, Ultasonic plastic welding

ALTAIR

https://altairengineering.fr

 

Activity : Altair helps designers and manufacturers of medical devices across the world achieve product development objectives through its unique approach, which blends CAE simulation software, design creativity, and in-depth engineering expertise to achieve optimal product designs.

ANDIG

www.andig.fr

 

Activity : ANDIG develops, manufactures and sells a wide range of position sensors, Human-Machine Interfaces (HMI) and industrial printers. Located in Allinges near Lake Geneva since 1982, ANDIG proposes standard products and custom-tailored solutions perfectly integrated in your application for control, measurement and data printing functions. Products : sensors, printers, joysticks, keyboards, interfaces...

 

Innovation : Slim position sensor. Contactless position sensor. FSR Force sensor.

APLUS SYSTEME AUTOMATION

www.aplus-sa.com

 

Activity : Established in 1988, APLUS Système Automation is one of the leaders in the French industrial computer industry. Our teams and our regional offices have expanded knowledge of multiple business applications in the areas of defence, security, industry at large, transportation and medical. For some of them particularly dedicated to medical applications : our embedded PC fully comply with standards. The largest French and European companies have trusted us for many years.

ARNOLD MAGNETIC TECHNOLOGIES

www.arnoldmagnetics.com

 

Activity : Engineering based manufacturer of permament magnets, magnetic assemblies and ultra thin metals for medical, aeronautical, space, formula 1 application.

 

Innovation : Equipped rotor for artificial heart (CARMAT)

ASMOLDING

www.asmolding.fr

Activity : ASMOLDING offers you its expertise and know-how in the design of plastic parts and manufacture of molds for the production of injected plastic parts : esthetics parts, functional parts, technical parts, complete products. Mono-materials, bi-materials (for seal or facade glass), overmolding inserts, light transmission (lighting), plastronics, mechatronics, multi-cavities, connectors, EMS boxes, IoT, coating / resealing electronic boards. Study office for co-design, materials choice, mold design, plastics. Molds workshop for series production molds, technical molds. Initiate Project (prototype part, part for testing, demonstrator, test different material, development of a functional unit, prototype molds, small series molds). ASM has its own trials center with 7 injection machines. Finishing on parts (sanding, graining, engraving, pad printing, painting, decor, assembly).

AXE SYSTEMS

www.axe-group.com

 

Activity : Axe Systems, supplier in manufacturing of medical devices, makes products destined to final assembly for mammogram and vascular sector to our customers, or example GE. We propose also mechatronics systems. We work for Air Liquide, in the breathing assistance sector. We purpose our skills in R&D, prototype and serial industrialization (fine sheet iron works, precision mechanics and integration). Our core business is assembly of mechanical devices linked to electronic in small and medium series. The atmosphere can be controlled or not (Air-conditioned ISO8 room). We have our own a study office (CAO 3D Pro engineer) where we develop prototypes, an industrialization office and a mechanical workshop (8 machining centers, 3, 4 and 5 axes, 6 CN turning centers, and an assembly workshop). We belong to the group AXE (300 employees) with Axe Metal located in Lisieux for fine sheet iron works and in Romania for sheet iron works and assembly.

BACKER

www.backercalesco.com

Activity : Backer is a technical industrial Electro thermic partner to the most important companies in several industry sectors. We deliver competitive solutions in the fields of measurement, heating, and control for leading companies in Medtech and Process industries. Our customers require innovative and custom technical solutions for their specific applications.

 

BOURSIER SOGREG

www.boursier-sogreg.com

 

Activity : Mold Makers and plastic injectors specialized in medical sector (ISO 9001 et ISO 13485). Subcontracting for the manufacture and assembly of Medical Devices. Design and production of tools. Developments and co-developments of plastic parts and medical devices. Clean room ISO 7. Biocompatible plastics, technical materials and high performance. Mono and bi-material plastic injection.

 

Innovation : Co-development of a sterilization chamber door with Lourd'Innov.

BSI GROUP

www.bsigroup.com

 

Activity : Through the passion and expertise of our people, at BSI we embeds excellence in organisations across the globe to improve business performance and resilience. We ensure patient safety while supporting timely market access for our clients Medical Device products globally. We provide our customers with thorough, responsive, predictable conformity assessments, evaluations and certifications that are recognized and accepted worldwide.

BUREAU VERITAS CERTIFICATION

www.bureauveritas.fr/certification

Activity : Bureau Veritas Certification is a leading company in test, inspection and certification. In health and medical devices, Bureau Veritas Certification is your partner for your certification according to ISO 13485 and data protection standards.

CADUCEUM

www.caduceum.fr

Activity : Caduceum is a consulting company in the fields of Pharmaceutical, Cosmectics and Medical Devices. Our expertise center for Medical Devices offers the following services: quality management system, system quality insurance, operational quality insurance, qualification & validation. Our Pharmaceutical expertise center offers the following services: strategy of marketing authorization registration, registration and marketing, product monitoring & exploitation, publishing and updating regulatory databases, customised regulatory monitoring, audits and due diligence. 

CANON BRETAGNE

www.canon-bretagne.fr

Activity : Canon Bretagne is a key player in electronic and electromechanical subcontracting, specialized in Medical Devices, offering a full range of services (Design office, industrialization/sourcing, production of electronic cards, development and production of injection parts, assembly of products or electromechanical assembly, logistics, after-sales service). Our certifications allow us to intervene in many domains (ISO 9001, ISO 13485, UL ZPVI2 ...).

Innovation : Complex assembly of  Medical Devices in different domains such as: blood analysis, urinalysis, perineal rehabilitation, automatic cleaning and lubrication for dental tools, continuous monitoring of intracranial pressure, etc ... Realization on our site of many parts (electronic cards, plastics, etc.) The medical activity represents more than 50% of our total activity in subcontracting.

CARL ZEISS SAS

www.zeiss.fr

Activity : Sale of 3-Dimensional measuring machines, form and surface, optical machines, X-ray tomographs and microscopes, software, engineering, automation / robotisation, fixturing, accessories, training, measurement and programming services, modernisation, calibrations and maintenance.

CARNOT CHIMIE BALARD CIRIMAT

www.carnot-chimie-balard-cirimat.fr

 

Activity : Synthesis of active molecules and nano-structured hybrid and composite materials for the transport and controlled release of active ingredients. Development of vectors and probes for the exploration of living things. Development of innovative medical devices. Our institute also puts its skills in formulation of active principles, new functional excipients and controlled release systems at the service of companies.

 

Innovation : WOMED is an innovative medical device to improve female fertility: this medical device aims to prevent the formation of intrauterine adhesions which are the cause of miscarriages and fertility problems (An innovation from the Artificial Biopolymers department of the Max Mousseron Institute of Biomolecules, part of the Carnot Chimie Balard Cirimat Institute and the Nîmes University Hospital).

CEA TECH

www.cea-tech.fr

Activity : CEA Tech is the CEA’s (the French Atomic Energy and Alternative Energy Commission) technology research unit. CEA Tech’s three labs—Leti, Liten, and List—develop a broad portfolio of technologies for ICTs, energy, and healthcare. CEA Tech leverages a unique innovation-driven culture and unrivalled expertise to develop and disseminate new technologies for industry, effectively bridging the gap between the worlds of research and business. In the Healthcare sector, CEA Tech develops diagnostic technologies (imaging, sensors, AI, …) and connected devices, among which a connected watch (optical signal treatment), a virtual reality headset (electrical signal treatment), an insulin delivery device, ...

CENTAUR CLINICAL

http://centaurclinical.com

Activity : Centaur Clinical supports manufacturers in the CE marking of medical devices, from pre-clinical testing, to clinical trials, then to post-market clinical studies. The team’s experience allows it to set up optimized studies, in particular in the areas of cardiology, oncology and intensive care. Centaur Clinical relies on a network of qualified partners in data management and biostatistics to offer the most relevant expertise according to your field, in the key steps of the trials. The company has been engaged in the ISO 13 485 certification process since 2019. CC runs its services in compliance with ISO 14 155 and GCP standards.

CENTRALP

www.centralp.com

Activity: Electronic partner of medical devices and laboratory equipment manufacturers, CENTRALP designs and manufactures electronic systems for industry (ISO 13485). Based on specifications, in compliance with standards EN 60601 and EN 62304, CENTRALP realizes: Customized boards (CPU, interfaces, video, ...). Integration of touch screens, motors, optics, boards, power supplies and other COTS. Custom PCs. Software development. Dedicated mechanics, boxes, … For 10 pieces or 2,000 pieces per year, CENTRALP is the partner in electronics that accompanies you, from design to maintenance, ensuring the durability of your equipment.

CERTEC

www.certec.fr

Activity: Certec is specialized in cutting and welding of technical materials for medical appilcations. Manufacturer of isolating chambers, inlfatable airtight pockets, vaccum pockets for radiotherapy, immobilisation systems for patient transportation. 2 innovations will be showed on the stand - one Covid isolation chamber and one portable hyperbaric chamber..

CF PLASTIQUES

www.cfplastiques.com

Activity : CF PLASTIQUES is recognized for its development and realization, as well as for its technical and powerful execution. Our unique offer is based on a rigorous management of confidentiality, the complementarity of our know-how in plastics and mechanics, a robust organization and certifications of healthcare markets and aeronautics (ISO 13475, EN 9100, ISO 9001). We support our customers to lighten the equipment, reduce the production costs of a part, functionalize the product, replace the metal by the high performance, the injector and/or the use of high-tech materials (PEEK, PEI, PPS , LCP or Titanium), manufacture a prototype part or series of high performance materials, etc.

CICOREL

www.cicor.com

 

Activity : The Cicor site in Boudry (Cicorel SA) is a manufacturer of high-end printed circuit boards, specializing in circuit miniaturization and highly demanding applications. The site develops and produces sophisticated rigid, rigid-flexible and flexible printed circuit boards and has comprehensive expertise in multilayer boards (MLB) as well as high-density and ultra-high-density interconnects (HDI and uHDI). Cicorel is working closely with its customers in the medical, automotive, aerospace and defence, communication, watches and consumer industries.

CONICIO

www.conicio.com

 

Activity : CONICIO is an industrial design agency offering an integrated design and engineering service for the creation and development of innovative products. This approach enables us to guarantee our clients that their projects will be transformed into products that are operational, industrially manufacturable and esthetically pleasing. Driven by an enthusiastic team of creators - designers, engineers and technicians- CONICIO can even support the different players in innovation to speed up the development of new products and increase the performance of the company. Thanks to its skills in product design, mechanical and material engineering, CONICIO has managed to bring value to professional equipment and consumer goods in various activity sectors and for a broad spectrum of companies.

 

COAT-X

www.coat-x.com

 

Activity : Coat-X’s novel technology can replace conventional and expensive metal, glass or polymer encapsulation/protection solutions. It can be used for many different applications such as: barrier protection for implants and wearables PCBs, encapsulation of corrosion sensitive micromagnets, protection and electrical insulation of instruments…The technology can be tailored to your application, providing a variety of potential benefits.

 

Innovation : Conformal biocompatible thin-film encapsulation technology platform

COPELECTRONIC

https://copelectronic.com

Activity : COPELECTRONIC gives the peace of mind of a proven track record in the medical, industrial and aeronautics sectors. We specialize in the production of electronic cards, electrical boxes and industrial and harnesses in small and medium series.

CREATIVE EURECOM

www.creative.fr

Activity : Creative Eurecom offers a complete service in development of innovative medical devices (class 1 & 2) and brings together a range of multidisciplinary skills (electronics, software, mechanics, plastics, fluidics, etc ...). Creative Eurecom accompanies you on all stages of development of your product: from the User Requirement Specification to the technical specification and from engineering to the prototypes and industrial process. Creative Eurecom has also a small and medium-size production capacity through its subsidiary Crossway Technologies. The two entities Creative Eurecom and Crossway Technologies are ISO 13485 certified.

Innovation : Production of a Device which aims at preparing medication on demand at the patient's home (EOL project). 

CREOPP-TEC / CREOPLAST

www.creopp-tec.com

 

Activity : CREOPP-TEC is a research and design office specializing in solutions for plastics processing and technical injected parts. Since 1996, CREOPP-TEC has been designing and monitoring the manufacture of tools of all kinds for the medical industry, but also for the automotive, cosmetics, toys, electronics, defence and other sectors. Our services range from design to industrialization through rapid prototyping, additive manufacturing, rheology, but also plastic injection in our ISO 9001v2015 certified CREOPLAST workshop. And thanks to our CII certification, our customers can obtain a tax credit on their innovations. In the medical sector, we collaborate with medical device designers or large customers such as Boehringer Ingelheim (formerly Mérial) to develop their projects and equipment.

 

Innovation : Smart glasses for people with AMD, pumps for treating Parkinson's disease, stretcher handles for ambulances or hospitals, pneumatic syringes for vaccinating chickens, ...

 

D&CONSULTANTS

www.detconsultants.com

 

Activity : D&Consultants have in-depth knowledge of the Medtech sector and its challenges thanks to our sector overviews of the medical device industry in France since 2011 for DGE and SNITEM. We also regularly support companies in this sector in their tech transfer or market access strategies, and their partnership initiatives (technical, financial, commercial). We also support them to obtain public funding.

DM EXPERTS

www.dm-experts.fr

Activity : DM Experts is an Internet portal designed to facilitate the search for consultants in the medical sector. It gives you access to a network of experienced independent consultants for quality and regulatory affairs, as well as a monthly newsletter on regulatory and normative news on medical devices: "Le Flash de DM Experts". Our services include training (e-learning or on site), advice and support. Innovation : E-learning or blended learning (online + follow-up on site) on medical devices regulation (EU) 2017/745, including training certificate delivered at the end of the training: over 250 persons already trained, satisfaction rate 95%. Similar training on in-vitro diagnostic medical devices regulation (UE) 2017/746 in preparation.

DPMR

www.dpmr.fr

Activity : Activity: Company specialized in machining of medical devices for over 20 years, mainly for orthopedics and spine. Thanks to an efficient machine park and to a highly qualified staff, we are at the forefront of technology. We meet the requirements  and we provide complete technological solutions. Our main strenghs are : the precision of the machining process, the quality and the cleanliness of the devices delivered. From design consulting to cleaning and packaging, we support you in the whole project.

DUBOURGEL MEDICAL

www.dubourgel-grange.com

Activity : Dubourgel Medical is known for its expertise in the field of syringe equipment and produces plungers, finger flanges, tubs, nests, luer lock adaptors (LLAs) and needle guards for the healthcare industry. Our services range from design to production in ISO 7 cleanrooms and include the production of moulds, product development, the creation of surgical ranges and quality processes. We also offer a range of sterile products for glass and COC syringes, so our customers don’t need to invest in basic equipment. In addition, we offer several possibilities for customization (large color range, translucent or solid finish, marking under certain conditions, packaging,…).

ELKEM SILICONES

www.siliocnes.elkem.com

Activity : Elkem Silicones is a leading fully integrated global silicone supplier with more than 60 years of formulation and manufacturing expertise. For healthcare applications, our Silbione™ range comprises silicone fluids and rubbers (RTV, HCR, LSR) which are biocompatible according to ISO 10993 and produced in controlled environment. Silbione™ products are used since many years in the manufacturing of medical components and devices like catheters, orthotics, wound dressing and long term implants.

 

Innovation : Silbione™ Biomedical silicones are manufactured in a certified ISO class 8 manufacturing environment, and are supported by material attestations, toxicological summaries, and letters referencing our Master Access Files (MAF) filed with US FDA by our on-staff toxicologists. The range includes biomedical liquid silicone rubbers, heat cure rubbers, and silicone adhesives that can be considered for the manufacturing of implantable devices like neurostimulation devices and catheter implants.

ELPACK

www.elpackpharel.com

Activity : We are specialized in board and complete electronic products assembly. ISO 13485 certified, we offer an extended service taking into account industrialization, purchasing, board & product assembly, testing and after-sales service/logistics. Our company’s values such as rigor, reliability, security and a sharped technological knowledge, allow us to position ourselves in the medical sector which represents 45% of our activity. Our electronic devices manufacturing’s for the medical segment are very diversified, ranging from miniaturized class 3 implants to complete and high-end ultrasound equipment.

EMITECH

www.emitech.fr

 

Activity : The Emitech Group is a major player in tests that apply to equipment. In the medical sector, our services are intended for manufacturers of medical devices (MD), laboratory equipment and paramedical equipment. We can give you an overview of the classification of your MDs, and inform you of what this entails in terms of procedures, testing requirements, and the documentation to be compiled. We can then guide you through each step of the process through to the marketing of your products. To be approved in Europe (CE marking) and in the rest of the world, equipment possessing telecoms functions must conform to tests covering multiple fields: electromagnetic compatibility (EMC), radio, EMF (electromagnetic waves & health)safety or mechanical. As the leader in environmental testing, the Emitech Group can offer you its expertise in all of these fields.

ENSINGER

www.ensingerplastics.com

Activity : Extrusion of biocompatible plastics acc.to ISO 10993 / USV Class VI, resistant to sterilization. Semi-finished products: TECAPRO MT (PP), TECASON P MT (PPSU Radel), TECASON P XRO (PPSU  X-Ray Opaque), TECAPEEK MT (PEEK), TECAPEEK CF30 MT (PEEKCF30), TECAPEEK MT  CLASSIX(PEEK CLASSIX), TECATEC MT CW50 (Composite PEEK reinforced  carbon fibres fabric). Machining of plastics parts. 3 & 5 axes 3D control, engraving, laser marking, cleaning, assembly, annealing. ENSINGER is your partner for all your project of medical parts from the choice of the material to the finished parts.

Innovation : Ensinger collaborates with main actors in medical sector in their most innovative projects like Carmat, Gensight Biologics, Carthera, etc.

EOLANE

www.eolane.com

 

Activity : Leader in industrial electronics and connected solutions, ÉOLANE manages the life cycle of a solution or an electronic sub-assembly according to a modular concept: Specifications, Design / re-design, Industrialization, Prototyping, Qualification, Series production, Logistics, Integration, TLS / After-sales service, … ÉOLANE helps you meet the challenges of cyber security, miniaturization, aesthetics and ease of use of your product. In the medical field, ÉOLANE worked on the following products and services: biological analysis portable reader, connected health booth, endoscope lean cleaning machine, self-diagnosis solutions, artificial heart, connected thermometer and pipette, class 3 connected alert disposal, in vitro diagnosis, ...

EMERGO BY UL

www.emergobyul.com

 

Activity : Emergo by UL is your unique partner in bringing safer medical devices, in vitro devices and combination devices to the global marketplace. Whether for established or emerging markets, when you work with Emergo, you benefit from the collective expertise of a global team specializing in regulatory compliance, human factors, regulatory affairs and quality. Emergo has offices on 5 continents, all with local teams experienced in their countries' regulatory requirements.

Innovation : RAMS  Saas Software: Developed by Emergo by UL experts, RAMS offers a growing portfolio of services to achieve EU MDD and MDR compliance. RAMS also includes product classification, regulatory monitoring, CER and CEP. Smart Builders provide essential assistance to companies transitioning to the new regulatory regime or wishing to bring their devices to the US market under the 510k procedure.

ERCE MEDICAL

www.erce-medical.com

Activity : Ercé Médical specialises in the design, production and marketing of technical and innovative medical devices. Our activity is composed of standard products (dosing pipettes, dosing spoons, granule counter and homeopathic globules) and tailor-made products in various medical sectors (ophthalmology, orthopedics, dentistry, diagnosis, infusion, ...).  We have a know-how and technical expertise recognized for more than 60 years in high dimensional accuracy and tightness (infusion bar - ophthalmic injector), high performance polymer processing (PEEK), high optical quality (consumables for optical reading system), assembly.

 

Innovation : Implementation of complex assembly machines in production rooms classified ISO 7. Development of a range of disposable devices (dosing pipettes, homeopathic tubes,...) in bio-based and biodegradable material. Integration of vertical presses to meet the needs of small and medium series.

ETABLISSEMENT FRANÇAIS  DU SANG

www.etablissement-francais-du-sang.fr

Activity : The core mission of EFS is to ensure national self-sufficiency in labile blood products under optimal conditions of safety and quality. EFS is the leading biomedical laboratory in France, it carries out different types of biological analyses which are designed to ensure product safety in the context of transfusions, but also in organ, tissue or cell transplants. By checking the compatibility of the characteristics of the recipient with those of the blood products intended for use, EFS has recognised expertise in immunohematology and immunogenetics. EFS is France’s leading producer of advanced therapy medicinal products (ATMP) for phase 1 and 2 clinical trials and a partner for the production of in vitro diagnostic medical devices. EFS carries out research activities in 18 research teams, working in partnership with Universities, CNRS, INSERM, University Hospitals and biotechnology companies. It conducts research in cutting-edge fields, contributing to scientific and medical advances in fields related to transfusion, cell and tissue therapy and engineering, immunology, microbiology, and clinical research. EFS Technologies related to medical devices that are available for licensing or co-developement are: innovative cryoresistant seringe injection system (prototype available), dressing for the healing of wounds, ulcers or burns of epithelia, endotheliums or mucous membranes (protected by patent application), equipment and method of dispensing blood bags (protected by patent application), sterile liquide transfer device (protected by patent application), rapid diagnostic test for genotyping (protected by patent application).
 

EUROFINS MEDICAL DEVICE TESTING

www.eurofins.com

Activity : Eurofins Medical Device Testing offers regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service, and most advanced technologies for your analytical chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs.

EUCLIDE INDUSTRIE LAM

www.euclide.pro

 

Activity : LAM is a subcontractor leader in the industrialization and manufacturing of medical devices. We are able to provide implants and complex instruments for different medical industries : spine, knee, hip, shoulder, … Our quality requirement guarantees all our customers the best practices in terms of qualification and traceability: mastered processes (QI/QO/QP), measurement system analysis, qualified team, devices history record.

 

Innovation : 5 axis milling center - high speed, Wire cut and sinker EDM, Turning center, Cutting tool - Stamping tool - Bending tool, Sandblasting - laser marking, Cleaning and passivation NFS 94-091 ASTM A967.

EVAMED

www.evamed.fr

 

Activity : Evamed is a clinical research organization created in 2005, specialized in the evaluation and clinical investigation of medical devices. Over the past 15 years, we have performed more than 180 interventional and observational studies and registries in France and around the world. Evamed helps you with your clinical projects or on different levels: clinical strategy, clinical investigation plan, Regulatory submissions, Remote and on-site monitoring, Data-management, Statistical analysis, Clinical Investigation Report, Publication. The alliance between the mastery of all stages in a clinical investigation and its own data collection software (eCRF & ePRO) makes Evamed a valued partner that meets the specific needs of the Medtechs.

FISBA AG

www.fisba.com

 

Activity : FISBA has been supplies photonics customers the widest range of capabilities in designing and manufacturing optical components and systems. Our highly specialized teams meet the complex and regulated demands of the Life Science, Defense & Aerospace, Industrial Production and Materials Processing markets, enabling the world's leading brands to fulfill their market potential. FISBA’s customer focused services range from ideation to device development support, engineering, supply chain optimization, to device assembly operations, all at our purpose-built facilities that support stringent market requirements while protecting our customers’ intellectual property. FISBA operates from locations in Switzerland, Germany & the US.

 

FISCHER CONNECTORS

www.fischerconnectors.fr

 

Activity : Fischer Connectors' solutions are ideally designer for medical electronic equipment, including diagnostic devices, surgical instruments, therapy applications, dental applications, cardiac assist devices, and disposable equipment. Our comprehensive medical connectors product line includes sterilizable, reusable, hybrids, as well as cost-effective disposable connectors. Custom designs are available to meet specific application requirements. Cable assembly options include silicon and low-friction coatings. Fischer Connectors helps medical device manufacturers reduce risk and run the FDA gauntlet by working closely to build just the right interconnect solutions.

 

Innovation : The Fischer Freedom™ Series is a breakthrough technology platform. Its versatile plug & use connectivity solutions offer easy mating, easy cleaning and easy integration for a multitude of Interventional & Surgical / Diagnostic & Imaging / Monitoring & Therapeutic applications. Fischer LP360™ connectivity solutions facilitate integration and optimize cable management in medical applications such as MRI, CT scanners, ultrasound, robotic surgery, dental applications, wearable devices, exoskeletons, heart-lung support systems, etc.

FLEIMA-PLASTIC GmbH

www.fleima-plastic.de

Activity : Medical tube extrusion in PVC, TPU, TPE, polyamide, LD-PE, HD-PE, PP, PVDF clean rooms of classes 6 and 8. Tubing applications in infusion, enteral nutrition, hearing aids, endoscopes, catheters, ventilation, ... (​Novoplast Schlauchtechnik). Injection moulded articles for applications in medical products, Luer-lock connectors, drip chambers, spikes, clamps. Assembling of modules (gluing, US-welding, UV-gluing), own tool shop. Projects. Validation, testing of biocompatibility (FLEIMA-Plastic).

FORT WAYNE METALS

www.fwmetals.com

Activity : Fort Wayne Metals is a leading manufacturer of medical grade materials. We produce medical wires, alloy composites, cables, bars and bioconductors from a wide range of metals including NiTinol, stainless steels, cobalt chromes, titanium and titanium alloys. Applications include catheters, guidewires, pacing and neurostimulation leads, orthopaedic and orthodontic devices.

 

Innovation : DFT® composite wire for bio-conductors

GREEN PLASTIQUE SOLUTIONS

www.greenplastique.fr

Activity : Assembling process solutions of different parts during the injection process. Recording of all the press datas in real time with ERP and EMS.

 

Innovation : In-Mould Assembly.

GRENOBLE INP ENTREPRISE

http://esisar.grenoble-inp.fr

 

Activity : Our industrial project is a collaborative R&D Framework for the SME and Start-Up. Grenoble INP has a high levels of feedback via its engineering school ESISAR, pragmatic partnerships and R&D activities. Companies undertake preliminary studies for validating phases and technical feasibility that lead to proof of concept with an efficient technology survey. Grenoble INP has completed over 500 projects with more 300 companies. The main R&D subject area are : IoT and embedded systems, wireless solutions, web and software engineering, HMI, cyber-security, Big Data, Machine learning.

GROUPE ICARE

www.groupeicare.com

Activity : ICARE is a international group with 5 specialized subsidiaries: Laboratoire ICARE, ICARE Biocompatibilité (LEMI et PHYCHER Bio développement for biocompatibility), ICARE Validation, ICARE Laboratoire Switzerland et ICARE Brazil. ICARE is service provider, expert in contamination control for all industrial health. Our main activity: Guarantee the safety of health products in compliance with the regulations.

 

HAMAMATSU PHOTONICS

www.Hamamatsu.com

Activity : Hamamatsu Photonics is a world leader in manufacturing optoelectronic components, modules and systems. We continue to stay a step ahead through our sensors, detectors and imaging systems, which are designed to cover the entire optical spectrum to target the most demanding of applications. Present across many markets, our photonic solutions are found in the medical, automotive, science research, environmental and analytical industries.

HUMAN DESIGN GROUP

www.humandesign-group.fr

Activity : Human Design Group is a leading company in Ergonomics, UX & Human Factor. Through a User-Centered Design approach, it helps healthcare industry to create and validate smart, simple and safe devices & software, compliant with usability standards and regulations. We provide support throughout usability engineering process (IEC 62366): conduct user research to bring expert knowledge on the future users and anticipate use-related risks, prototype, test and iterate on innovative User Interface (physical and digital), validate final design through comprehensive user tests (summative evaluation) for regulatory files.

HYBRID SA

www.hybrid.swiss

Activity : Founded 30 years ago, Hybrid SA brings unique skills to the field of electronic assembly. Mastery of advanced electronic assembly technologies (ChipOnBoard, Wirebonding, FlipChip, Chip Stacking, ….) allows us to offer personalized solutions tailored to each project. The great flexibility of our organization allows us to accommodate projects ranging from proto-demonstrators to series, including assistance in the development of industrialization processes. Our teams are always ready to take on the most ambitious challenges.

I2S-BE VISIONARY

www.i2s.fr

 

Activity : i2s has been helping his customers to take up their most complex challenges using imaging in the areas of health and wellness with expertise in the development of in-vitro diagnostic medical devices and high-tech connected portable tools at competitive cost. The i2S Medcare business relies on a multidisciplinary team that has acquired 40 years of expertise in image capture and processing with recognized scientific, software, technical and regulatory expertise in the fields of optronics and integrated, automated, and enhanced imaging. i2S offers you to benefit from its portfolio of technological bricks, including 3D imaging and learning by Artificial Intelligence.

 

Innovation : Connected portable devices: 3D micro-scanner for impression taking - camera for diagnosis - Automated Time-Lapse Digital Microscope enhanced with Image Processing and Learning by Artificial Intelligence for IVF - Real-time automated measuring device for immuno-hematology - Automatic antibiograms for micro-biology - Digital Data Libraries for the Scientific Community - Any type of advanced imaging devices or imaging kits in OEM, Private Label or own label

IMCD ADVANCED MATERIALS

www.imcdgroup.com

 

Activity : IMCD is a global leader in the distribution of specialty chemicals. IMCD Advanced Materials offers an extensive range of innovative raw materials including rigid and elastomeric polymers as well as customised compounds for the following segments: implantable and non-implantable medical devices, dental, drug delivery, medical and pharmaceutical packaging, diagnostics and surgical equipment. IMCD assists its customers in all phases of development of their medical devices by providing technical support for the choice and processing of polymers. IMCD has a European stock  which allows fast deliveries of small and large quantities. IMCD also provides all the documentation related to biocompatibility (USP Class VI / ISO 10993), notifications of changes as well as any other needed regulatory and technical documents.

INFODREAM

https://infodreamgroup.fr/

Activity : Infodream specializes in manufacturing quality control solutions. Our innovative solutions have helped companies achieve manufacturing excellence for almost three decades. Our modular MES Software for Industry 4.0 caters for both SMEs, beginning their smart factory journey looking to firstly create a paperless workshop, through to large industrial groups implementing fully connected multi-site projects. Infodream has a strong history of working with the pharmaceutical and medical industries. Qual@xy SPC allows your company to meet the regulatory requirements of bodies, such as the FDA and PAT, whilst simultaneously giving your company the opportunity to increase productivity and profits.

 

INSTITUT CARNOT INGÉNIERIE@LYON

www.ingenierie-at-lyon.org

Activity : Bio-engineering plateforms: tissue engineering (hard and soft) of biomaterials, exploration of the mechanical properties of skin. Development of imaging and medical monitoring solutions, medical robotics such as medical simulators, implants and diagnostics. Studies of the encapsulation of active ingredients for targeting cells, formulation of active cosmetic agents targeting skin, formulation, physicochemical characterisation, biopharmaceutical evaluation.

INSTITUT CARNOT MICA

www.carnot-mica.fr

 

Activity : Specialist in functional materials, surfaces and interfaces, the Carnot MICA Institute supports companies in the design and development of their products and services. With his 15 laboratories and technical centers, all experts in materials and innovative solutions, the Carnot MICA Institute offers companies a comprehensive offering, ranging from basic research to industrial applications. MICA has developed especially strong expertise in the field of healthcare, materials for the patient and the therapeutic environment, and ensures control of every stage, from materials design to clinical trials, with its own teams of surgeons. MICA's solutions are ideal for medical devices, pharmaceutical and diagnostics sectors, in the form of R&D programmes, services, expert reports and consulting and technology transfers. Boost your R&D with the Carnot MICA Institute !

 

Innovation : Antimicrobial surfaces / additive manufacturing / CLAD process / First larynx implant / Tissue and Bone regeneration / Biological matrices / inflammation / implant biofunctionalisation / Durability bench for prosthesis (fatigue test)

INTLAND BY SOFIA TECHNOLOGIES

https://sofia-technologies.com

Activity : Sofia Technologies is a value-added reseller of team collaboration tools from Intland Software. We offer added value services with Intland’s solutions that include pre/post-sale consulting, integration & implementation, training and 1st & 2nd level support. Intland Software is the editor of Retina, an agile platform for the management of your Requirements, Risks, Tests and Documentation, ready for use for medical technologies, life sciences and pharma industries.

 

Innovation : Retina powered by codeBeamer is an agile management platform of your requirements, risks, tests and documentation, launched in 2019 by Intland Software, that covers your R&D needs for lifecycle management of your next equipments, software and solutions. Intland Retina helps you break down silos along product development. It provides traceability from requirements through testing, validation, and release with great user experience and team productivity features. Out-of-the-box integrations and data sharing capabilities help unify your tool ecosystem. The platform’s responsive UI enables access on both PC and mobile devices. Ready-made medical technology, pharma & life sciences templates shorten your route to value.

IONISOS

www.ionisos.com

 

Activity : IONISOS group offers all the industrial technologies for sterilization by radiation and ethylene oxide to meet the needs of manufacturers in the pharmaceutical, medical-surgical, cosmetics industries. The treatment by ionizing radiation offers all possible levels of decontamination : from the debacterialization of cosmetics to the sterilization of medical devices.

JBT HUB UP

www.jbt-hubup.com

 

Activity : JBT HUB UP is a unique solution gathering all operational skills to supply a global solution (design, execution, assembly, qualification, regulatory…) at the beginning of the design of your medical device. JBT HUB UP alliance groups companies, leaders on their markets and provide their knowhow in the Pharma and medical market: - Connected device, e-plastic… - Design and construction of molds – Plastic injection – ISO7 clean rooms - LSR, silicone injection/extrusion - Design and construction of assembly machines, robotized systems, vision and controls – Product and process validation. From the idea of a medical device until the product is on the market, JBT HUB UP alliance makes your project alive and drives it in full confidentiality. A global offer providing both the agility of a small company and the power of an international group.

 

Innovation : JBT HUB UP alliance makes your project alive and drives it by providing more skills: Connected device, e-plastic, LSR, silicone injection/extrusion, design and construction of assembly machines, robotized systems, vision and controls.

KEYSIGHT TECHNOLOGIES FRANCE

www.keysight.com

 

Activity : eysight Technologies, Inc. (NYSE: KEYS) is a leading technology company that helps enterprises, service providers and governments accelerate innovation to connect and secure the world. Keysight's solutions optimize networks and bring electronic products to market faster and at a lower cost with offerings from design simulation, to prototype validation, to manufacturing test, to optimization in networks and cloud environments. Customers span the worldwide communications ecosystem, aerospace and defense, automotive, energy, semiconductor and general electronics end markets. Keysight generated revenues of $3.9B in fiscal year 2018.

LA PRECISION

www.laprecision.com

 

Activity : LA PRECISION is specialized in the production of high-precision parts by machining and subcontracting in precision micromechanics. We produce machined components in bar turning, CN turning, UGV milling and 3D printing. In the medical field, LA PRECISION manufactures complete components and products for dental implantology, cardiac stimulation, orthopedics, neurosurgery, etc. We have a wide range of technologies at your disposal to deliver finished and packaged parts (in a blister or other).

LASER RHONE ALPES

www.laser-rhone-alpes.fr

 

Activity : ISO 13485 certified, Laser Rhône Alpes has been using laser technology (welding, cutting and marking) for over 30 years. Laser welding makes it possible to assemble materials such as Titanium or Stainless Steel without adding material to preserve their bio-compatibilities. This technology is used for welding on medical devices (implants, ancillaries ...). With laser equipment installed in an ISO 7 clean room, Laser Rhône Alpes offers cleaning, welding and packaging processes in a controlled environment.

 

LYONBIOPOLE

www.lyonbiopole.com

Activity: As a Bio Cluster, Lyonbiopole is the gateway to healthcare innovation in the Auvergne-Rhône-Alpes region. It’s supporting ambitious projects and innovative companies in the healthcare & life sciences’ sector. Its aim is to help innovators develop new technologies, products and services in a push toward a more personalized medicine and better treatments for patients.

MANUDO MEDICAL

www.manudo.fr

 

Activity : Production site in clean room ISO 7 and 8- Custom designed and Know-How : Certified ISO 9001 ISO 13 485 and ISO 14 001, MANUDO is dedicated for the Medical Device in: heat sealing, high frequency welding, and thermoforming. Production of flexible packaging as : Biotechnology bags, dialyze, blood bags, heater bags, freezer bags, cells culture bags.. Technical inflatable : Air/water/gel. Blister and medical packaging for implants….Etc..  Made with specific material: EVA, PU, PVC DEHP Free, PETG medical, PC, complex film, PEHD, PEBD, SEBS, PP, etc..

MATRIX REQUIREMENTS GmbH

www.matrixreq.com

 

Activity : Matrix Requirements GmbH have created software solutions that streamline the quality management system and the creation of the technical files needed for certification of medical devices. Our ISO 13485 solutions can help you to create all the necessary documentation for the design history file, technical file, submissions to authorities and notified bodies (MatrixALM). Our software also helps you manage your procedures, work instructions, CAPAs and other records you need to maintain for your quality system (MatrixQMS).

 

MDP Maxon France

www.mdp.fr

 

Activity : MDP-maxon France, French subsidiary of the maxon group, is specialized in high mechatronics technology: development, engineering and production of drive systems. Thanks to its integrated engineering department, MDP-maxon France answers with agility to customer expectations for active implantable class III devices or laboratory machine systems for example. The company is also specialized in drive systems for surgical tools, drug delivery systems, imaging and exoskeletons. Certified ISO9001 in France and ISO13485 in Switzerland.

MESCAN

www.mescan.com

 

Activity : Mescan is the exclusive distributor of Tekscan pressure mapping systems and FlexiForce ultra-thin force or position sensors. These solutions, widely present in the industrial sector and used in a growing number of medical biomechanical applications, are now offered to OEM and IoT integrators. Besides these products, Mescan is also the distributor of Genge & Thoma precision potentiometers and manipulators and Imetrum 2D/3D video extensometry systems. Mescan can assist you in the integration of its measurement technologies in your processes from R&D to the integration of customized solutions.

MICROCERTEC

www.microcertec.com

 

Activity : Microcertec is specialized in technical ceramic and silica materials, in the design of products and their manufacturing with various processes. We manufacture custom-made components for high-tech industries such as medical instruments, medical & scientific analytical equipment, high-vacuum, dental, sensors. We have an expertise in some kinds of products : high-voltage insulators for the high-vacuum, heat sinks, laser reflectors, 3D interconnect devices, mechanical /wear parts for the bio-medical, ceramic-to-metal brazed assemblies, glass-to-metal seals.

MINALOGIC-EASYTECH

www.minalogic.com

 

Activity : Minalogic is the digital competitiveness cluster. The technologies, products and services developed by ecosystem players address all sectors of activity and cover the entire digital value chain combining micro / nano / electronics, photonics, software, content and uses. Easytech is aimed at start-ups and SMEs allowing them to accelerate the development of innovative products, services or processes through the transfer of digital technologies from laboratories and / or engineering schools. It combines expertise, support and funding to support innovation.

MIP MEDICAL

https://mip-medical-plastics.com

 

Activity : Co-development and production of plastic medical devices in clean rooms : MIP Medical is an ISO 13485 certified plant and complies with ISO 15378 (drugs packaging). MIP is producing plastic parts in ISO 7 and ISO 8 clean rooms for different areas. From the idea to the final product, MIP Medical will support you to design and produce your plastic medical devices. MIP Medical has automated injection molding machines from 40 to 320T (closing force) and also offers assembly, pad printing, packaging and storage of your goods (new warehouse up to 1500 pallets). With its design office and its industrialization department, MIP helps you along your project to select the raw material, and to design your product in accordance to your requirements specifications. Our Quality department is ensuring a permanent regulatory monitoring and support customers in their CE marking process.

 

Innovation : Single use medical device for angioplasty.

MOLEX DEUTSCHLAND GmbH

Imke.Kuester@molex.com

 

Activity : Molex offers medical device OEMs a trusted source to build competitive advantages in electronic systems and devices. With our portfolio of medical interconnect solutions and a deeply consultative approach we provide end-to-end solutions that enable success.

 

Innovation : Modified standard products, Fine wire terminations, IC adapters, Bare die packaging, Molded interconnect devices, Microelectronics, Wearable sensors , Integrated sensor assemblies, Custom interconnects, Flexible printed electronics , Metal, plastics and rubber, (2-shot LSR) molding, Capacitive switches, Display panel backlighting, Capillary tubing, Silica fiber.

NAMSA

http://namsafrance.fr/

 

Activity : Established in 1967, NAMSA was the first independent company in the world to focus solely on testing medical device materials for safety. Today we have a physical presence in 8 countries on 4 continents and over 1000 dedicated professionals. NAMSA offers services from Consulting to Testing to Clinical throughout every stage of the medical device development life cycle. The NAMSA team has extensive knowledge and experience in most therapeutic areas in the medical device space. Our Services : Consulting (regulatory strategy and quality systems, market access strategy, biological safety and validation, Reimbursement, Medical writing / CER), Testing (functional studies, In vivo and in vitro biocompatibility, analytical services, microbiology), Clinical (clinical trial management, Biostatistics, Data management, Site monitoring and safety).

 

PACKAERO MECATRONIQUE

www.packaero.com

Activity: With state-of-the-art know-how in precision electrodynamic and hydromechanical equipment and high reliability from space aerospace, PACKAERO is a major partner for high performance mechatronics solutions for DMs. Our Voice Coil electrodynamic motors, regulating solenoid valves, electrodynamic vibrators, sensors platform are outstanding vectors of innovation for dynamic and intelligent prostheses, surgical robotics, medical imaging, intelligent instrumentation.

POLYMEREXPERT

www.polymerexpert.fr

 

Activity : PolymerExpert is a company specialized in the field of innovative and high added value polymers. We offer our services in R&D, analysis and production of polymers. Today, the medical sector represents 70% of the turnover realized by PolymerExpert. Indeed, our intelligent polymers have found their place in many applications: shape memory plugs, photochromic intraocular lenses, sliding coating for urological probes, single-phase cement for vertebroplasty...

Innovation : Copolymer for blood filtration, Development of a hydrophilic coating, Encapsulation of active ingredients (textile, pharmaceutical, cosmetic) , Synthesis of biomaterials for medical and pharmaceutical applications, Development of hydrophobic, hydrophilic, photochromic intraocular implants (ophthalmology), Development of sliding polymers (implant injectors, probes, catheters...), Development of self-repairing breast prostheses for cosmetic surgery, Development of quality control prior to bone cement production, Development of residual monomer assays

PORTESCAP

www.portescap.com

 

Activity : Portescap offers best - in class solutions to meet the motion needs of medical and industrial applications. We serve performance - critical applications with a broad offering of electronic miniature product technologies - brush DC, brushless DC, stepper can Stack, digital linear actuators, disc magnet and gearhead/encoder/drive technologies. Portescap products have been serving diverse motion control needs in wide spectrum of medical and industrial applications -medical, life sciences & clinical diagnostics, instrumentation, automation, aerospace and security applications, for more than 70 years. Portescap has manufacturing centers in the United States and India, and utilizes a Global Product Development network with research and development centers in the United States, India, and Switzerland.

PRECITEC

www.precitec.de

Activity : Designer and manufacturer of optical sensors for 3D dimensional metrology. Distance, thickness, flatness ISO, roughness, autofocus, high-speed, high resolution. 2D vision system for in-line microscopic inspection. Based on 20 years of experience in developing of chromatic confocal sensors and probes, Precitec offer high precision and ultra fast solutions with micrometric resolution for topography and thickness measurement. We have the technical expertise of several types of technologies (chromatic confocal, interferometry white light and infrared) and several configurations (point, multi-point, line and field) on any type of surface or material (metal, plastic, glass, semiconductor, etc) to bring you the right solution to your needs. 

PURELAB PLASTICS

www.purelabplastics.com

Activity : PureLab Plastics, specialized in development and injection molding in controled environment, offers an expertise fully dedicated to Life Sciences, medical and pharmaceutical technologies (medical devices, consumables, instruments, implants, DDS). We offer a full-service including : An engineering team of 11 experts from project design, development all the way through industrialization, Scientific Injection Molding and Eco-Design approach (molding control, material reduction, biosourcing), a compliant manufacturing environment (ISO 7, ISO 8, ISO 9), quality compliance addressing regulatory requirements (ISO 13485, cGMP’s, ISO 14001, CSR), an evolving production and assembly capacity to support our customers including associated services (sterilization, packaging, logistics).

 

Innovation : Integration of iterative development and scientific plastic injection. Development of precision plastic, fluidic, micro-fluidic and micro-injection capabilities. Expansion of injection prototyping services combining cost reduction and good material manufacturing. Some examples of products: Life sciences (precision consumables for molecular biology techniques), medical devices (connecting elements, micro syringes, capillary pistons), implants (lumbar implant, vertebral implant).

RAUMEDIC

www.raumedic.com

Activity : With 70 years of experience in extrusion, injection molding and assembly, RAUMEDIC is optimally equipped to transform the ideas of its customers into well-engineered product solutions. We process medical-grade thermoplastic polymers and silicones at 4 production sites in Germany and in the USA. Furthermore, the medical engineering company develops and produces high-precision pressure measurement systems with microchip technology for the indication areas of neuromonitoring and traumatology.

RESCOLL

www.rescoll.fr

Activity Rescoll Development has a strong experience in bonding technology, surface treatment, polymer and composite fields for medical application. Our R&D department can meet your needs for Literature review, Surface Treatment, Reverse Engineering, Development, Prototyping and Scale-up. Rescoll Manufacturing offers a wide range of services to prototype, manufacture and control your medical devices and instruments. A variety of custom implants for orthopedic, maxillofacial, dental and cardiac fields could already be developed under ISO 13485 standard.

Innovation : Rescoll has made significant developments in the fields of electrospinning for tissue engineering, surface functionalization through bioactive coating or the formulation of absorbable composite materials and 3D printing for bone regeneration.

ROUEN INNOVATION SANTE

www.rouennormandyinvest.com/simplanter/poles-dexcellence/rouen-innovation-sante

 

Activity : In partnership with the CHU of Rouen Normandie, the Unicancer Becquerel Center, the University of Medicine and Pharmacy and the Medical Training & Testing Center, Rouen Innovation Santé supports companies and startups in the fields of biotech, medical technology, IoT, robotics, imaging, diagnosis & nutrition. From one hour to Paris, the second French Region in the field of medicinal chemistry and the third Region dedicated to production of drugs benefits from a structured Research, qualified human ressources and a financing network taking part in all the steps of creation, innovation and development. The Economic Development Agency "Rouen Normandy Invest", offers support & expertise to make new projects become reality !

SCHURTER

www.schurter.com

 

Activity : SCHURTER develops and manufactures products for circuit protection or human interface for electronic devices. Connectors, power entry module also with filters, fuses, PCAP and capacitive switches with medical approval for certain standard part of our catalog.

 

Innovation : TA 35 circuit breaker antibact. Cord retention system for devices. Multi-functional Connectors According to IEC 60601-1-11 with. Protection Class II

SCULPTEO

www.sculpteo.com

 

Activity : Sculpteo, high quality 3D Printing online service since 2009, addresses the production needs of the medical industry for prototypes, individual products, and short and medium runs. Sculpteo provides access to a wide range of materials, finishes, and superior optimization tools, as well as specialized engineers in design for additive manufacturing.

SEFAR FYLTIS

www.sefar.com/fr

 

Activity : Sefaris leader in fabrication of monofilament fabrics for the medical sector. Our PET and PA materials conform to standard 21 CFR 177. The functions are safety filtration, blood filtration, dispersion, drainage and mechanical reinforcement. Hydrophilic and biocompatible treated fabric for diagnostic application. Hydrophobic membrane filters contaminants, bacteria and viruses present in the gases. The confection is operated in clean room class 7 ISO 14644 in accordance with standard ISO 13485.

SELENIUM MEDICAL

www.selenium-medical.com

Activity : The innovations and patented solutions (StarSurf, SoEasy, SoKlean, SoBliss) highlighted here are the cornerstone of Selenium Medical’s business and the key of its strong growth. Indeed, SoBliss, our revolutionary sterile blister has received a prestigious award from the WPO (World Packaging Organization). Focused on the medical devices world, but always daring to go further and thinking outside the box, SELENIUM MEDICAL develops and designs the solutions of tomorrow to enhance the medical devices designed by its customers, to improve the operating room practices and the patient well-being. This capacity to innovate and launch new products on the market in the current regulatory environment demonstrates our skills in Quality/Validation/Regulatory Affairs. This is also why every year, close to 10% of our turnover is realized through consulting activities while assisting our customers in their 510k and CE submissions.

 

Innovation : StarSurf: Nano-Etching process for titanium implants - SoBliss: Revolutionary sterile double blister with vertical hinge 100% no touch - SoKlean: Titanium holder 100% no touch for clean dental surgery - Colorbox: Anodizing equipment

SGH HEALTHCARING

www.sgh-healthcaring.com

 

Activity : SGH Healthcaring grew out of the merger of 3 plastics processing firms specialising in medical devices and drug administration: Stiplastics, Rovipharm and Eskiss. Their reputation for know-how, developed over more than 30 years, means they can offer a comprehensive range, from standard production to tailor-made development and medical subcontracting. In addition to manufacturing at several facilities certified to ISO 13485, including cleanrooms, it offers its customers expertise in quality, R&D, industrial production and marketing. The SGH Healthcaring group designs and manufactures effective, innovative solutions in four main areas: drug and supplement administration for solid and liquid medicines, respiratory conditions, diagnostics & pre-analytics and e-health.

STAE

www.stae.fr

Activity: Since more than 35 years, STAE (ISO 13485) is helping many companies in medical field : studies, manufacturing (electronics and wiring, mechanics and sheet metal working, assembly and integration), risk analysis, prototypes, testing (validation, CE marking, …), maintenance, … From start-ups to multinational companies, STAE finds the suitable solution to your issues. From concept pre-study to final test phases by complete manufacturing, the scope of STAE's offer allows our clients to trust our know-how.

 

Innovation : Thanks to its experience working with many medical companies, STAE could innovate many times to optimize manufacturing. This known innovative ability allows our client to benefit from our 10 years of experience in Medical and others domains.

SUPERMETAL

www.supermetal.fr

 

Activity : Company psecialized in the following fields: machining operation, shot-peening, laser marking, passivating, anodising, finishing, heat treatment for medical device in the rachis and dental sectors, and cancerology.

 

Innovation : Factory 4.0

TECHCI RHÔNE ALPES 

www.techci.fr

Activity : Printed circuit board manufacturer: Multilayer, Flex-rigid, HDI rigid and HDI Rigid-Flex, High speed cards, thermal management... PCB Division consist in 3 European sites with TECHCI / CISTELAIER / EPN. We have a strong know-how on embedded products, CISTELAIER is ISO 13485 certified

THIEME S.A.S.

www.thieme.eu/fr/polyurethane

 

Activity : THIEME has 40 years of experience in the design and manufacturing of custom RIM parts in polyurethane. RIM process. Moulding of housings, panels, enclosures and functional parts. Surface finishing and assembly of ready to use systems. Current markets : Medical; Analysis and laboratory equipement, etc.

 

Innovation : Plastic covers with anticollision system integrated, antimicrobial and antibacterial painting.

TORTOISE

www.tortoise.io

Activity : Tortoise unique technology extracts valuable mechanical properties from a scanned height map obtained from only a single fracture surface of small size. This technology finds application in several domains including failure analysis, oil & gas or for the development of high performance materials.

Innovation : the statistics fractography, an innovation for machanical failure analysis and characterization of materials.

TRANSVALOR

www.transvalor.com

 

Activity : Transvalor is the world leader for process simulation of material forming. In the medical sector, the Transvalor solutions are used to simulate the forging and the precision casting of orthopedic implants (Hip stems, tibial keels, shoulders, ankle or elbow made of stainless steel, titanium, zirconium or cobalt-chromium alloys) and also injection molding of plastic components (syringes, vascular access medical devices). Modeling is also invoked in the bio-medical context of soft tissues of aortic valves or to understand physical phenomena (stress in joint disks) and in certain circumstances to limit pain experienced by patients. Transvalor is a French company established since 1984 and located in the heart of the Sophia-Antipolis technology park. It currently employs more than 70 employees.

TRONICO-TAME CARE

www.tronico-alcen.com

 

Activity : TRONICO specializes in the design, industrialization and manufacturing of electronic systems. Based on 46 years know-how and on unique means dedicated to the medical market, the company has an extended offer addressing each stage of the product life cycle, from its definition to the management of end of life. Its location in Nantes and Tangier allow a high flexibility in the design and production for its customers. Today, TRONICO's know-how is used for implanted or non-implanted active medical devices for major contractors, but also for SMEs or start-ups (with a dedicated solution).

TSA

www.tsa.fr

 

Activity : TSA/ADAMANT NAMIKI uses cutting-edge technologies and offers micro motors in standard or customised versions, cylindrical, flat, servo, DC-BLDC, from standard size 4mm, and with integrated gears or coders (available from size 7mm). The integrated gears are either standard planetary gears or patented Dynalox self-locking gears. The CS series (4 poles micro motors) has improved performances compared to standard version: +60% torque constant, -60% time constant. They are mostly used in motorised micromechanical equipment with high performance requirements (size/power ratio), but also in applications where a very low noise-level is required.

TURCK DUOTEC

www.turck-duotec.com

 

Activity : High-quality electronics produced in “state of the art” modern and clean facilities. 30 years of experience in miniaturization from the initial concept to high volume production. Layout and material optimization including testing, procurement and cost management. Production from small to large series in various locations around the world. Fast time to market.

USE CONCEPT

www.useconcept.com

 

Activity : The final user being our main focus, our experienced team adapts to your needs in order to offer the optimal procedure for the integration of ergnomics. Useconcept consultants are specialised in considering the various aspects of human factor in healthcare especially in Medical Devices (MD EN62366), pharmaceutical products and Healthcare Informatics (HI). We thus provide you with an ideal support for the conception and qualification of your MDs’ usability and for the improvement of the ergonomics of medical softwares.

VALTRONIC TECHNOLOGIES

www.valtronic.com

 

Activity : Valtronic is a full-service contract manufacturer dedicated to medical devices. Worldwide companies rely on our 35+ years of experience to develop, industrialize and manufacture innovative Class I to III medical devices, including active implants. Our expertise includes turnkey devices, microelectronic assembly and miniaturization. Headquartered in Switzerland, our company spreads over three continents with manufacturing sites in Switzerland, the United States and Morocco and employs more than 350 employees worldwide.

 

Innovation : Examples of medical devices developed and manufactured thanks to our expertise in microelectronics, miniaturization and turnkey device assembly: deep brain stimulation probes, intelligent contact lenses, disposable endoscopes, cochlear implants, insulin pumps, implantable morphine pumps, automated diagnostic systems.

VECTOR

www.vector.com

Activity : Embedded Solutions for Medical Engineering : Vector provides medical device OEMs, CMOs and suppliers with a professional and open development platform of tools, software components and services for creating embedded systems. Three fields of application are in particular focus: Software Testing (automated tests of embedded medical applications), System Testing (simulation & test environments for Medical Systems), Systems Engineering (manage complexity with Model-Based Processes).

VELFOR GROUPE

www.velfor.com

Activity : Velfor Group is specialized in the transformation of flexible and rigid plastic, by thermoforming and high frequency welding. We offer tailored solutions : blisters for syringes, hinged boxes, treatment boxes, pillboxes, conditioned sets, displays, infusion bags, filter bags, dialysis bags. We propose a global offer : feasibility study, management and purchasing components, clean rooms ISO 7 and ISO 8 manufacturing, traceability, logistics, sterilization, Biodurden test, leak test, resistance test... We are also ISO 13485 certified.

 

Innovation : Conditioning of medical devices in clean rooms with associated controls. This innovation is a diversification of our product offer.

WESTLAKE PLASTICS EUROPE

www.westlakeplastics.com

Activity : 2 activities to serve the medical sector : Production of semi finished products made from a wide range of polymers (rods, sheets film and thin sheets for thermoforming) which are FDA or USP VI or ISO 10993 compliant. Finished Medical Devices obtained by machining on our 23 CNC machines. Our laser marking and cleaning equiments are qualified. Our 3 plants (extrusion and compression in the US and machining in France) are ISO 13485 compliant.

ABOUT MEDI'NOV...

As an exchanges platform dedicated to decision-makers in the medical industry since 2013, MEDI'NOV CONNECTION has become an must-attend meeting offering to medical actors (equipment manufacturers, medical devices manufacturers and subcontractors) to participate in a program of networking and conferences related to the innovations of the sector.

ORGANIZATION 

FIRST CONNECTION - 8 Rue La Fontaine  |  92120, Montrouge

Tel : 01 49 12 44 95

Fax : 01 49 12 48 74

info@firstconnection.fr            

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