ISO 13485

Quality manual for medical device manufacturer

Quality manual, ISO 13485 and MDR, free template

By Guillaume Promé
Sep. 24, 2021 ISO 13485, Regulation (EU) 2017/745

Quality manual template for medical device manufacturers, according to ISO 13485 and Regulation (EU) 2017/745

ISO 13485:2016+A11:2021

EN ISO 13485/A11: Annex ZA and ZB for regulations 2017/745 and 2017/746

By Guillaume Promé
Sep. 23, 2021 ISO 13485, Regulation (EU) 2017/745

Review of Amendment A11 to EN ISO 13485:2016, containing Annexes ZA and ZB for regulations 2017/745 and 2017/746.