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



VenueHollywood, Online Online



Topics/Call fo Papers

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.
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'
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. FDA-regulated industries,

Last modified: 2021-02-23 16:58:16