The DHF, DMR, DHR, and the Technical Documentation File - The US FDA and EU MDR Requirements

This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.

It will consider the EU's recently revised MDR and it's 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; Similiarities 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 "Genneral 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 - the Technical Documentation FiIe. Currently they serve differnt purposes, 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) in both sides of the Atlantic.

Areas Covered in the Session:

• 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

• Senior Management in Devices,and Combination Products
• QA
• RA
• R&D
• Engineering
• Production
• Operations
• Marketing