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Healthcare 2020 - Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

Date2020-11-04

Deadline2020-11-04

VenueOnline, USA - United States USA - United States

KeywordsHealthcare; Pharmaceutical; Medical online training

Websitehttps://www.compliance4all.com/webinar/d...ts--503410

Topics/Call fo Papers

Overview:
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.

Last modified: 2020-10-24 18:55:50