Regulatory Affairs in Bourgogne-Franche-Comté

Regulatory Affairs - Assembly in controlled atmosphere - Medical device design office - Marketing of non implantable medical devices - Design of non implantable medical devices - Design and manufacturing of medical devices (class 1) - Design and manufacturing of medical devices (class 2) - Design and manufacturing of medical devices (class 3) - Consulting in homologation (CE marking) - Degreasing / Cleaning / Washing / (clean room) - Packaging (clean room) - Manufacturing of medical devices (ISO 5 room) - Manufacturing of medical devices (ISO 7 room) - Manufacturing of non implantable medical devices - Manufacturing in clean room

Regulatory Affairs - Medical device design office - Co-development of products - Design of connected medical devices - Design of implantable medical devices - Design of non implantable medical devices - Design and manufacture of laboratory instruments - Design and manufacturing of laboratory tools - Design and manufacturing of medical devices (class 1) - Design and manufacturing of medical devices (class 2) - Design and manufacturing of medical devices (class 3) - Design and manufacturing of connected medical devices - Design and manufacturing of in-vitro devices - Design by digital simulation - Advice on certification - Consulting in homologation (CE marking) - Advice on innovation - Calibration of measuring equipment - Feasibility studies - Studies and development of test bench - Additive manufacturing (printing of other materials) - Metrology (laboratory) - Prototypes (design) - Prototypes (medical devices) - Mechanical testing and numerical simulation (vibrations, shocks, drops) - Pullout adhesion test

Regulatory Affairs - Assembly in controlled atmosphere - Medical device design office - Design of connected medical devices - Design of implantable medical devices - Design of non implantable medical devices - Design and manufacture of electronic cards - Design and manufacturing of medical devices (class 2) - Design and manufacturing of medical devices (class 3) - Design and manufacturing of connected medical devices - Advice on certification - Consulting in homologation (CE marking) - Degreasing / Cleaning / Washing / (clean room) - Feasibility studies - Studies and development of test bench - Metallographic examination and chemical analysis - Manufacturing of medical devices (class 1) - Manufacturing of medical devices (class 2) - Manufacturing of medical devices (class 3) - Manufacturing of connected medical devices - Manufacturing of medical devices (ISO 5 room) - Manufacturing of medical devices (ISO 7 room) - Manufacturing of implantable medical devices - Manufacturing of non implantable medical devices - Industrialization of assembly processes by welding techniques - Silicone injection - Laser (welding) - Micro-assembly - High precision micro-injection - Nitinol shaping - Prototypes (medical devices) - Qualification of manufacturing processes - High frequency welding - Resistance welding - Welding under qualification

Regulatory Affairs - Assembly of sub-assemblies, electromechanical, mechatronic, mechanical assemblies with a volume < 5cm3 - Assembly of sub-assemblies, electromechanical, mechatronic, mechanical assemblies with a volume > 5cm3 - Broaching - Methods office / Industrialization - Mechanical pickling (tribofinishing) - Free-cutting < Ø3 mm - Free-cutting >10 000 parts - Free-cutting >100 000 parts - Free-cutting >50 000 parts - Free-cutting from 10 to 1000 parts - Free-cutting from 1001 to 10 000 pièces - Free-cutting from Ø10 mm to Ø20 mm - Free-cutting: from cutting thickness Ø20 mm to Ø32 mm - Free-cutting from Ø3 mm à Ø10 mm - Free-cutting from Ø32 mm to Ø60 mm - Free-cutting: from cutting thickness > to 2 mm à 50 mm - Free-cutting: from cutting thickness 0,2 to 2 mm - Degreasing / Cleaning / Washing - Chemical metal deposition (nickel plating) - Electrolytic metal deposition (nickel plating) - Tribo-finishing deburring - Manufacturing of assemblies and sub-assemblies - Manufacturing of medical devices (class 1) - Manufacturing of medical devices (class 2) - Manufacturing of medical devices (class 3) - Manufacturing of implantable medical devices - Manufacturing of non implantable medical devices - Engraving - Metrology with contact (rolling) - Internal use - Contactless metrology (vision probe, optical sensor, laser scanner) – Internal use - Micro screw-cutting - Knurling - Barrel polishing (tribofinishing) - Crimping - Tapping - Tournage 2 axes - Tournage 3 axes - Tournage 4 axes - Lathe-turning / large series (> 10,000 parts) - Lathe-turning / medium series (from 1,001 to 10,000 parts) - Multifunctional latheturning - Tournage Ø 401 mm à 1000 mm - Tournage Ø de 20 à 200 mm - Tournage Ø de 201 à 400 mm - Lathe-turning / small series (from 11 to 1,000 parts) - Prototypical and unit latheturning (< 10 parts) - Base metal machining

Regulatory Affairs - Assembly of sub-assemblies, electromechanical, mechatronic, mechanical assemblies with a volume > 5cm3 - Design office (implementation of CAD solutions) - Automation design office - Medical device design office - Electronic design office (hardware and firmware) - Mechatronics design office - Design of non implantable medical devices - Design and manufacture of laboratory instruments - Design and manufacture of centrifuges - Design and manufacturing of medical devices (class 1) - Design and manufacturing of medical devices (class 2) - Design and manufacturing of in-vitro devices - Design and manufacture of robotic solutions - Study and realization of robotic islands - Manufacturing of medical devices (class 1) - Manufacturing of medical devices (class 2) - Manufacturing of medical devices (ISO 5 room) - Manufacturing of medical devices (ISO 7 room) - Manufacturing of in-vitro medical devices - Manufacturing of non implantable medical devices - Industrial computing (system integration / software) - Food injection - Rubber injection - Industrial injection - Thermosetting injection moulding - Thermoplastic injection moulding - Prototypes (design) - Prototypes (medical devices) - Prototypes (manufacturing)

Regulatory Affairs - Machine safety audit - Consulting in homologation (CE marking)

Regulatory Affairs - Advice on certification - Consulting in homologation (CE marking) - Endurance testing (performance) - Climatic and ageing testing (performance) - Spectrometer (analysis, measurement, control)

Regulatory Affairs - Medical device design office - Methods office / Industrialization - Marketing of non implantable medical devices - Design and manufacturing of medical devices (class 2) - Packaging (clean room) - Manufacturing of medical devices (ISO 8 room) - Prototypes (design)

Technical industrial adhesives - Adhesive system - Air abrasive blast cleaning - Regulatory Affairs - Machining tool sharpening - Industrial compressed air - Oil analysis (mechanical, hydraulic) - Hardness testing - Assembly / Wiring of connectors - Cutting, bending, rolling, high precision stamping - Tribo-finishing deburring - Stamping - Stamping - Manufacturer of luxury items - Manufacturer of watchmaking tools / Jewelry - Jewelry manufacturer - Eyewear manufacturer - Flat spring manufacturer - Manufacturing of tools for cutting - Manufacture of press tools - Manufacturing of non implantable medical devices - Cold forging of steel / small and medium series - Laser (welding) - Maintenance of tools - Forging - Micro machining - Micromechanics - Shaping of metallic wires - Drilling - Folding - Barrel polishing (tribofinishing) - Manual polishing (brushing / satin finishing) - Ferrous / non-ferrous metal products (processing and sales) - Straightening - Rolling - Sandblasting - Satin finishing - High frequency welding - Traditional welding / brazing - Spot welding - Resistance welding - Pad printing - Tapping - Heat treatment in a tempering oven - Controlled atmosphere heat treatment - Steel wire transformation - Cold steel wire drawing - High-speed machining / 4 axis / medium series (from 1001 to 10 000 parts) < 350 cm3 - High-speed machining/ 5 axis /prototyp and unit (< 10 parts) < 350 cm3 - Base metal machining

Regulatory Affairs - Assembly (gluing, welding, riveting) - Assembly of sub-assemblies / Electrical / electronic assemblies - Assembly in controlled atmosphere - Medical device design office - Electronic design office (hardware and firmware) - Mechanical engineering office - Mechatronics design office - Methods office / Industrialization - Design of sensors for non-destructive testing - Design of implantable medical devices - Design of non implantable medical devices - Design and manufacture of laboratory instruments - Calibration tools design and manufacturing - Design and manufacture of precision tooling - Design and manufacture of electronic cards - Design and manufacture of printed circuits - Design and manufacturing of medical devices (class 1) - Design and manufacturing of medical devices (class 2) - Design and manufacturing of medical devices (class 3) - Design and manufacturing of connected medical devices - Design and manufacturing of in-vitro devices - Design and manufacture of special machines - Non-destructive testing (NDT) equipments design and manufacturing - Design and manufacture of mold - Design and manufacturing of checking fixtures - Design and manufacturing elastomer mouled parts - Design and manufacture of plastic parts - Design and manufacture of non-destructive examination systems - Consulting in homologation (CE marking) - Eddy current - Degreasing / Cleaning / Washing / (clean room) - Wire EDM <Ø 0,10 - Sinker EDM - Packaging (clean room) - Packaging (grey room) - Climatic and ageing testing (internal use) - Mechanical and fatigue testing (internal use) - Manufacturing of medical devices (ISO 5 room) - Manufacturing of implantable medical devices - Manufacturing of non implantable medical devices - Industrialization of products / processes - Silicone injection - Thermoplastic injection moulding - Laser (welding ISO 7 clean room) - Micro-assembly - Micro-winding - Micromechanics - Prototypes (design) - Qualification of manufacturing processes