Dr. Stéphane Naudin

Dr. Stéphane Naudin

Medical devices / Biocompatibility
Senior Consultant


Stéphane joined the global medical device team and has in-depth knowledge of European regulatory and biocompatibility requirements for non-active, implantable medical devices ­­as well as for reusable instruments and single-use devices, especially for orthopedic and urology. Stéphane is based in Germany.

Stéphane about working at Qserve

"At Qserve I appreciate the high level of expertise combined with the practical approach offered to our customers. The intercultural and interdisciplinary team, the agile infrastructure make the work efficient and interesting: it's always in a good working atmosphere.  I like the broad range of regulatory topics and the variety of medical devices our customers entrust us which makes my job at Qserve dynamic and always challenging."

Before Qserve

Stéphane has 20 years of experience in the medical devices field, ten of which have been spent as R&D engineers in an American orthopedics and sports medicine company and two at a major Notified Body (TÜV SÜD). In this latter position, he was a product specialist for absorbable implants and orthopedic cements.

During his activity in the industry, Stéphane worked as a developer and project manager focusing on the development of minimal invasive instruments for various orthopedics surgical techniques, shoulder implants as well as single-use devices. In other companies, he gained the opportunity to support the development and the documentation of different medical products such as sterilizers, spine implants and instruments, robot-assisted navigation and ablation lasers. He worked with contract test labs including biocompatibility test labs as well as many German and Swiss suppliers from metal and plastic machined as well as 3D-printed parts.

Stéphane has a degree in Mechanical Engineering and Biology and a PhD in Toxicology.

The key expertise areas of Stéphane

  • Detailed knowledge of the Medical Device Regulations 2017/745 for all classes of medical devices, including class III (absorbable) implants
  • Advice, set up, preparation or review of technical documentation in support of compliance with the Medical Device Regulation 2017/745
  • Provision of regulatory advice and strategy during product development or changes according to MDR from the design input over the risk assessment and V&V to the registration procedures
  • Advice, set up, testing strategy, preparation or review of biocompatibility documentation according to the ISO 10993 standards
  • Expertise in test planning and reporting e.g. biomechanical, bioburden, biocompatibility, physicochemical, reprocessing and particle testing on raw materials and finished products
  • Technological/product expertise in the following areas: orthopaedic instruments and implants, bone substitute materials, absorbable implants, urology, steam sterilisers, medical lasers
  • Expert review of mechanical drawings and related documentation including post-manufacturing processes e.g. coating, electropolishing and related QC
  • Exchange with EU notified bodies and authorities during registration procedures
  • Work in cross-functional project teams with a focus on regulatory issues
  • Lead and work in interdisciplinary project teams
  • Languages: French, German and English (written and verbal communicating skills)
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