I am a Seniour consultant in the medical device regulation with experience in active medical devices with a fascination for new product development.
I have worked for an innovative start-up that developed a class III medical device (under MDR 2017/745) including hardware and software. As Manager QA/RA I was responsible for achieving certification according to ISO 13485 and coordinating the technical file. In addition, I had an active role in the design and development process by conducting design reviews and approving design documentation such as design specifications, detailed designs, test protocols and test results.
My fields of expertise are in:
– Set up and maintenance of technical files;
– Development and implementation of Quality Management Systems;
– Internal / supplier auditing;
– Active medical devices, including software development;
– Coordination of communications with regulatory authorities;
– Risk management (ISO 14971);
– Usability Engineering (IEC 62366-1).