Post Market Surveillance FAQ
What is Post Market Surveillance (PMS)?
What’s it used for? Why do you need it?
We have all the answers and more…
What is Post Market Surveillance (PMS)?
What’s it used for? Why do you need it?
We have all the answers and more…
This case study looks at fast tracked PMCF activities and how CLIN-r+ supported one manufacturer with their Clinical Data Acquisition for EU MDR submission from an MDD Certificate based on Equivalence.
Post Market Surveillance is a collection of processes and activities used to monitor the performance of a medical device. Clin-r+ identifies what your Notified Body wants to see in the Post Market Surveillance Plan and PSUR/PMSR.
Clin-r+ shares how the QMS underpins this process, how the PMS process sits within this, and divides Post Market Surveillance between reactive and proactive PMS.