Post Market Surveillance

ISO 13485 gives us an outline of a quality management system (QMS) structure which compels the need for a feedback system specifically to provide early warning of quality problems and for input into corrective and preventive action processes for our medical devices.

Post-Market Surveillance has become crucial according to the new European Medical Device Regulation (MDR).

Our Method

We are trying to improve how we analyze failure trends thanks to our data analysis team. Our special software allow us to analyze complaint record data to identify trends and patterns that may represent opportunities to reduce or eliminate specific customer issues.

Our primary objectives are to summarize and prioritize the findings from field actions and projects showing anticipated benefits to customers. Post-Market team is leading deep cross-functional root cause investigations on potential product compliance issues and communicate outcomes across different functions and levels within our company.

With the risk management team, we drive updates to risk management documentation and risk management methodology to improve Post Market systems and processes.

We plan, prepare, review findings and discuss at quality data review (QDR) periodic meetings. One of our main goals is to finalise QDR activities owned by Failure Analysis Engineering (FAE) and other departments.