This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Also considered: Areas requiring frequent re-evaluation / update; Similiarities and differences; Future trends; Typical DHF Table of Contents, Technical File or Design Dossier Table of Contents, The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity",self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
Why should you Attend: One of our most popular webinars, now expanded to 3 hours, and continuously updated with the latest U.S. FDA and Eurpean Union 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).
In order to sell globally, the EU's CE-marking documentation is a requirement the Technical FiIe or Design Dossier and now, Technical Documentation under the new EU MDR (Medical Device Regulation), which replaces the MDD (Medical Device Directive). Transitioning consideration / concerns.
The DHF / D&DP serve different purposes, support different goals, than the TF / DD / TD, but there are increasing similarities. And the DHF is adapting to some of the features of the TF/DD. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both. Against the background of 21 CFR 820.30, ISO 13485:2016 7.3, and the transitioning from EU MDD to MDR.
Areas Covered in the Session:
The U.S. FDA's 21 CFR 820.30 Design History File (DHF) and the ISO 13485:2016 Design and Development File
The EU's MDD / MDR and the Technical File / Design Dossier / Technical File
Device Classification U.S. FDA vs. EU MDD/MDR
Design Contol vs. a Product 'Snapshot in Time'
DHF "Typical" Contents
The DMR and DHR / Lot / Batch Record
TF / DD / TD Expected Contents, Essential or General
Safety and Performance Rqmts
Use Engineering File (IEC 62366-1, -2)
Parallel Approaches to Documentation Teams
FDA and NB Audit Focus
There will be two breaks approx. 10 min each, and a Q&A session(s)
Who Will Benefit:
Senior Management in Drugs, Devices, Biologics, Dietary
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.