NAYE François (QSERVE)
Implementation of quality management system for medical device (ISO 13485).
Change control management.
Usability management (IEC 62366).
Risk management for medical devices (ISO 14971).
Prepare and review technical documentation according to MDR.
Implementation of ISO 62304 for medical device software.
Internal and supplier audit.
Front line for notified body of competent authorities inspection.
Training on quality and Regulatory topics of employees.
Strong scientific and technical writing skills.