EU MDR Requirements 2021 - DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements

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.
One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF).
The EU's MDR and the Technical File / Design Dossier
Device Classification - U.S. FDA vs. EU MDR
Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies
Speaker:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.