3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs

John E Lincoln
John E Lincoln
Tuesday, August 30, 2022
10:00 AM PDT | 01:00 PM EDT
3 Hours

More Trainings by this Expert   Product Id : 504625

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$290 Live
$490 Corporate Live
$340 Recorded
$540 Corporate Recorded
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This seminar will examine the existing requirements for theUS FDA's DHF including its derivative documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and its Technical Documentation File requirements, and evaluate the documents' differing purposes/goals.

Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation/update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical Document File Table of Contents; The importance and usefulness of the old "Essential Requirements", now "General Safety and Performance Requirements" and a suggested matrix format; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file inspections/audits by the FDA and Notified Bodies will be discussed.

Why should you Attend: 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. The cGMPs mandate Design Control and the Design History File (DHF). ISO 13485 mandates the same, a Design and Development File, per 7.3, which is now to be part of the EU's MDR-required documentation.

In order to sell globally, the EU's CE-marking documentation is a requirement of the Technical Documentation file. Currently, they serve different purposes and support different goals, but their roles do overlap. And how/where do the DMR and DHR fit? Being aware of the similarities and differences can further concurrent development and/or updates to both, especially for those companies marketing (or plan to) on both sides of the Atlantic.

Areas Covered in the Session:

  • The EU's MDR and the Technical Documentation File
  • Design Contol vs. a Product 'Snapshot in Time'
  • DHF "Typical" Contents
  • The DMR and DHR / Lot / Batch Record
  • Technical File Expected Contents
  • Focus on the General Safety and Performance Requirements and Why
  • Parallel Approaches to Documentation Teams
  • FDA and NB Audit Focus

Who Will Benefit:
  • Senior management in Devices, and Combination Products
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing

Speaker Profile
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. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

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