One of our most popular Seminars, 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 planning to) on both sides of the Atlantic.
Also considered: Areas requiring frequent re-evaluation/update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical Documentation Table of Contents; The importance and usefulness of the new 'General Safety and Performance Requirements' (replacing the old 'Essential Requirements'); Structure of the 'Declaration of Conformity'; self-declaring or N-B reviewed and changes; parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
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 planning to) on both sides of the Atlantic.
Why you should attend
This seminar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR, and DHR. It will consider the European Union's new MDR Technical Documentation requirements, which replace the old Technical File/Design Dossier. It will evaluate the documents' differing purposes/goals, as well as the two different device classification schemes, and CE-marking requirements. 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 Documentation Table of Contents; The importance and usefulness of the new 'General Safety and Performance Requirements' (replacing the old 'Essential Requirements'); Structure of the 'Declaration of Conformity'; self-declaring or N-B reviewed and changes; parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
Agenda
- The U.S. FDA's DHF
- 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
Speaker
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.Who Should Attend
- Senior management primarily in Devices, Combination Products
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Marketing
