The FDA Medical Device File (DHF, DMR, DHR, Market Authorizations) and EU MDR Technical Documentation
Navigate FDA DHF, DMR, DHR, and EU MDR Technical Documentation requirements — understand the similarities, differences, and how to align global medical device documentation.
Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
What You'll Learn
About the event
About this event
One of our most popular webinars, updated with the latest FDA and EU requirements. As U.S. companies go global, they must meet different product design documentation requirements, but with key similarities. The cGMP's mandate Design Control and the Design History File (DHF). In order to sell globally, the EU requires the CE mark, a QMS, and a Technical File.
This webinar examines the existing and proposed requirements for the FDA's DHF — including its derivative documents, the DMR and DHR. It considers the EU MDR Technical File/Design Dossier requirements and evaluates the documents' differing purposes and goals. Also covered: areas requiring frequent re-evaluation, similarities and differences, future trends, and the differing approaches to file audits by the FDA and the Notified Body.
Code: MD3259
Curriculum
Requirements
- QA, Regulatory Affairs, R&D, Manufacturing, and Engineering professionals in medical devices
- Applicable to documentation specialists and marketing departments in regulated device companies
Meet Your Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
John E. Lincoln has over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment including QMS and software validations, ISO 14971 product risk management files/reports, Design Control/Design History Files, and Technical Files. He has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). John has prior experience in military, government, electronics, and aerospace industries. He is a peer-reviewed author, teacher, and speaker, and a graduate of UCLA.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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