Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR RequiremeSeptember 8, 2020 - CA US
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical documentation File Table of Contents; The importance and usefulness of the "General Safety and Performance Requirements" (the old "Essential Requirements"); Structure of the "Declaration of Conformity"; self-declaring changes and/or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.