MDR Requirements 2021 - 3 hrs Webinar DHF, DMR, DHR, Technical Documentation and the EU's MDR Requirements

This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDR's tD -- how to meet and document them. Their differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update.
Global companies must meet different product design documentation for the U.S. and the European Union / Common Market. The cGMPs mandate Design Control and the Design History File (DHF). ISO 13485:2016 has identical requirements under Design and Development.
The U.S. FDA's DHF
The EU's MDR and the Technical Documentation File
Design Contol vs. a Product 'Snapshot in Time'
Speaker:
Principal, J. E. Lincoln and Associates LLC. John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S.