Are these findings observations in your CERs ?
1 March 2021 CERSome companies finished their MED DEV R4 updates while some going through their NB reviews currently. Most of the IIb and III CERs that manufacturers compiled are good with REV 4 but may not be with EU MDR (especially in the areas of Equivalence, if claimed and other areas like SOA and PMCF parts which […]