Hi Covers,
Does anyone know anything about version 8 of MedDev 2.5.2 "Reporting of Design Changes and Changes of the Quality System" - I have found many web references to it but it appears that it was maybe withdrawn? What do you use to guide you regarding reporting changes in Europe since Rev 7 is no longer active either.....Thanks!
Does anyone know anything about version 8 of MedDev 2.5.2 "Reporting of Design Changes and Changes of the Quality System" - I have found many web references to it but it appears that it was maybe withdrawn? What do you use to guide you regarding reporting changes in Europe since Rev 7 is no longer active either.....Thanks!
I also found the attached doc on the NB-MED site (see link earlier in this discussion). It appears it was added November 2011 and is called approved but it has redlines....