The 5 most important steps to CE certification - The EU medical device approval process

This video introduces the Europan medical device regulations, in particular the Medical Device Regulation MDR, the conformity assessment procedures (sometimes referred to as "certification process") and the medical device classification.

It explains when an ISO 13485 certified quality management system is required and which are the most relevant documents manufacturers have to compile

You find the checklist mentioned in the video and additional information in our starter-kit: https://www.johner-institute.com/starter-kit/

Видео The 5 most important steps to CE certification - The EU medical device approval process канала Johner Institute