1. As we are a low-risk class I one medical device manufacturer, if we want to declare our conformity according to MDR do we also need to comply with all the applicable harmonized standards like (ISO 13485, ISO 14971, IEC 60601-1-2) ? Or are these standards optional for class I?
2. Do we need ISO 13485 or other certification from an accredited body?
Assign topic to the user
Comment as guest or Sign in
Oct 20, 2020
Oct 20, 2020
Oct 20, 2020