Yves Gautier Happy

Verification and validation of rejuvenation devices

— Technical verification on beauty industry devices;

— Write technical reports on processes and usage;

— Test and validate different technologies integrated into rejuvenation devices.

— HIFU (High-Intensity Focused Ultrasound);

— EMS (Electrical Muscle Stimulation);

— Iontophoresis;

— RF (Radio Frequency);

— Phototherapy.

Development of an electromedical system combining embedded electronics and software. Realization of functional studies and risk analyses according to ISO 14971. Monitoring of prototyping, performance optimization, and writing of test reports. Writing of DHF (Design History File) documentation. Coordination with quality teams to ensure ISO 13485 and MDR compliance. Participation in internal and external audits (notified bodies, FDA).

Design of critical software for a medical diagnostic device. Software validation according to IEC 62304. System integration with mechanical and electronic teams. Monitoring of tests in accredited external laboratories. Writing of V&V reports and technical documentation.