The Post-Market Surveillance Document: Which Ones Do you Need?
It's not enough to make a device and put it on the market—you must [...]
Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?
Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when [...]
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by [...]
Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to [...]
Post Market Surveillance Under the EU MDR
There are only a handful of explicit things that you MUST do for Post [...]