QiP GmbHPost-market surveillance and vigilance for medical devices - a task for us too
What is it about:
Market observation, or post market surveillance (PMS), refers to the proactive monitoring of the medical device market. The MDR/IVDR obliges manufacturers to monitor their product after it has been placed on the market - and to also do the same for their similar products. To do this, the manufacturer implements a system to plan, carry out and document these activities in a report.
Let us help you - verifiably and professionally
QiP GmbH can carry out this service on your behalf. We would be happy to create for you:
Documents for market observation (selection, if applicable)
- PMS plan
- PMS report
- PSUR
- PMCF plan or PMPF plan
- PMCF report or PMPF report
- Clinical evaluation or performance evaluation
- Risk management file
- Vigilance documentation
We will be happy to advise you on your product without obligation!
More information