The Product-Monitor for manufacturers of medical devices
The new EU Medical Device Regulation (MDR) obliges manufacturers to monitor medical devices after they have been placed on the market (PMS / Post-Market Surveillance).
This includes systematic collection and analysis of real-world data (PMCF / Post-Market-Clinical-Followup).
The following objectives are to be achieved:
Identify product defects or systematic application errors promptly and counteract them proactively
Reduce complaints or evaluate them on a sound basis
Continuously optimise safety, performance and usability
identify off-label uses
detect statistically significant increases in the frequency or severity of adverse events (monitoring trends)
The Product-Monitor supports medical device manufacturers in meeting these complex requirements. It includes 3 Modules: