This seminar will examine the existing requirements for the 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.
Areas Covered:-
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.
Who Should Attend:-
