Dr. Cyrille Gasquères

I help medical device manufacturers successfully navigate regulatory challenges by providing expert support in regulatory compliance, CE marking, and the implementation of quality management systems in accordance with European and international requirements.

Management of Regulatory Affairs Teams: Define regulatory strategies for Class III implantable Annex XVI products and drug/device combinations. Successfully achieved recertification under the MDR for the entire product portfolio. Oversee the operational budget for the Regulatory Affairs team, ensuring efficient resource allocation and financial management.

In charge of the regulatory strategies for class III medical devices, drug/device combination and MDR implementation.

Support the development of innovative coating technologies for implantable medical devices. RA support for class III medical devices, drug/device combination, bioresorbable implants.

Responsible for the development of innovative technologies for medical devices (antibacterial coating, magnesium alloys...). Coordination of cross-functional teams (including product management, marketing & sales, and QA/RA), external consultants and surgeons. In charge of the operational budget.

Development of new coating technologies for medical devices: titanium and magnesium alloys implants used in trauma and orthopedic fields. Preparation of technical documentation for CE approval of medical devices (class III). Design and CE marking of coating machineries.

Development of new coating technologies for biomedical applications. Improvement of antibacterial and osseoinduction properties of titanium alloys implants used in the trauma and orthopedic fields. Upscaling and standardization of lab scale processes to production level. Preparation of technical documentation for CE approval of medical devices. Design and CE marking of coating machineries.

Development of surface treatments by atmospheric plasma for adhesion promotion (with Goodyear), anti-sticking coatings and hardening of carbon steels (with ArcelorMittal).

Development of new thin films with strong dielectric constant (SrZrO3 and ZrO2) for mobile electronic applications (with Thales) by Liquid Injection Metal-Organic Chemical Vapor Deposition (CVD).

Development of new thin films materials (Cr3(C,N)2 and CrxSiyCz) to be used as barrier against copper diffusion in microprocessors (with CEA-Leti) by Metal- Organic Chemical Vapor Deposition (MOCVD).

Thin Films, Materials characterization