Quality, Software & Training Expert
Senior Consultant
Introduction
François Naye works as a Senior Consultant for the Qserve Group where he is part of the Qserve Conseil team and experienced in developments particular in software.
Before Qserve
François holds a PhD in molecular biology from the university of Bordeaux. He worked 5 years as a researcher in Belgium universities prior jumping into the quality and regulatory affairs world. He worked two years for a small IVD company where he was in charge of establishing technical documentation and risk management activities for certified products under the medical device directive.
Then he joined an international Belgian medical device company where he learned to work in multicultural environment. This experience provides him an interest into the management of software. One of the reasons for which he joined for 3 years a medical device startup working on sleep apnea. He has implemented a quality management system and the technical documentation for European and US regulations.
In all his different positions, François has sought to be involved in training activities as he finds it rewarding to make people aware and autonomous. With his scientific knowledge, his quality and regulatory experience and his passion for innovation, François wants to help companies to make their product available to improve patient’s life.
The key expertise areas of François:
- 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 or competent authorities inspection
- Training on quality and regulatory topics of employees
- Strong scientific and technical writing skills
Training Qualifications:
Regulatory areas: EU MDR 2017/745
Subjects:
- Auditing
- Computer System Validation
- Quality Management Systems
- Risk Management
- SW Management per IEC62304
- Usability engineering IEC62366