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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.

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1.5 hours

Instructor

John E. Lincoln

FDA Regulatory Affairs, Design Control & QMS Expert

The FDA Medical Device File (DHF, DMR, DHR, Market Authorizations) and EU MDR Technical Documentation

Quantity

Recording – 1 Viewer

$290.00

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Secure payment via Stripe

Certificate of completion

What You'll Learn

The U.S. FDA's New QMSR Document Term Changes

Design History Files (DHF) — structure, contents, and FDA expectations

EU MDR and the Technical Documents/File requirements

Design Control vs. a product snapshot in time

DHF typical contents, DMR and DHR / Lot / Batch Record relationships

FDA and Notified Body audit focus — similarities and differences

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

QMSR Document Term Changes and the FDA's New Requirements

12 min

Design History File (DHF) — Structure and Typical Contents

12 min

DMR, DHR, and Their Relationship to the Batch Record

10 min

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.

40+ Years FDA Regulated Industries30 Years Independent ConsultantUCLA GraduateDesign Control & Technical File Expert

Quantity

Recording – 1 Viewer

$290.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

Topics

DHF DMR DHR EU MDR Medical Device Design Controls QMSR Technical File

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