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