10times
24 Feb 2021 • 

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

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upto 100
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Feb 2021

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Newly Listed
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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.

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