Category: Medical Device Regulation MDR
Interesting read from BSI – MDR Documentation Submissions Best Practices Guidelines
MDR and IVDR implementing measures rolling plan – December 2018
Survey regarding where members of Team-nB are in the MDR designation process – Team-NB is publishing a survey on the MDR designation process present stages in which Team-NB notified bodies member are. Pesquisa sobre onde os membros do Team-nB estão no processo de designação para o MDR – Team-NB is publishing a survey on the MDR designation […]
Manufacturers with CE Marking shall update their procedures and forms. Fabricantes com Marcação CE devem atualizar seus procedimentos e formulários. Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) New Manufacturer Incident Report helptext.