A26 – Increasing Post-Market Vigilance Requirements for Medical Devices

Global regulatory authorities are increasingly applying stricter obligations on medical device manufacturers and sponsors. The need to report and trend all types of complaints and incidents (adverse events) is becoming a significant burden, but one which cannot be avoided.

This increasing burden comes at a time when the new ISO 13485:2016 standard is being introduced which places greater emphasis on risk management. This session will explore the differences in post-market vigilance and surveillance and how to establish best practice in meeting increasing regulatory and ISO 13485: 2016 requirements. Perspectives from the manufacturer/sponsor and regulator will be explored.


Chairperson: Paul Cohen, Director Scientific Affairs, Biointelect