Post-Market Surveillance of medical devices: from reactive to proactive
Einstein C Room
2:30 pm to 3:15 pm
A medical device manufacturer is expected to continuously generate evidence of safety and performance of its medical devices on the market. Post-Market Surveillance is the key process within a Quality Management System (QMS) that ensures such expectations are met. Traditionally based on a reactive approach, the current way of designing and implementing PMS activities is challenged. Manufacturers are pushed to proactively collect relevant safety and performance information to continuously support clinical evidence. Proactivity shall be considered to generate valuable feedback for other two QMS vital processes: risk management and clinical evaluation. A question arises: can a manufacturer be proactive enough?