I am a senior consultant in the medical device regulation, with experience in both medical devices and in vitro diagnostic devices.
I have worked for an IVD company with List B and self-certifiable devices (under IVDD 98/79/EC) and Class I and Class II devices (Under 21 CFR) . As integral project leader R&D I was responsible for development of new products in collaboration with instrument manufacturers. In the role of Product Change Control Manager I was responsible for maintenance of the Design History File and performing Change Control on products released into the market.
For a Medical Device company I have worked as Quality Assurance officer. In that role I have had an active role in the implementation of the design and development procedure, including IEC 62304 for software and ISO14971 for risk management.
My fields of expertise are in:
– Set up and maintenance of technical files;
– Development and implementation of Quality Management Systems;
– Internal / supplier auditing;
– Non active medical devices and IVD’s;
– Coordination of communications with regulatory authorities;
– Risk management (ISO 14971);