24 Feb 2021 • 

3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs


Official Links

Estimated Turnout

upto 100


Feb 2021


Newly Listed
Claim event to edit details

This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its .. Read more derivative documents, the DMR and DHR. It will consider the European Union’s MDD TF/DD and its transition to the EU MDR 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 File or Design Dossier Table of Contents, The importance and usefulness of the “Essential Requirements”; Structure of the “Declaration of Conformity”,self-declaring 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.

  • Share your Experience
  • Organizer
LogoRequest a Booth

Webinar Compliance

Canada65 Total Events / 21 Upcoming Events

More Events From The Organizer