Post Market Surveillance
The Medical Device Directive requires:
- A quality system that is established with a commitment to post market surveillance.
- That your Notified Bodies verifies that the manufacturer is conducting the require post market surveillance
- That your clinical evaluation include post market data.
Your post market surveillance data comes from complaint data and post-market investigations. If you Complaint System is stratified against the harms and failure modes in your Design History File; the task of maintaining the data is greatly simplified.