Module 14 2022

MDR Technical Documentation – Best Practice

BSI provides this guide. A complete and well-organised technical documentation file decreases time and cost of the review. Require searchable, bookmarked PDF files Technical documentation should be available in full in accordance with Annex II & III

https://www.bsigroup.com/globalassets/meddev/localfiles/de-de/documents/bsi-md-mdr-best-practice-documentation-submissions-en-gb.pdf

The Organisation for Professionals in Regulatory Affairs