This webinar will examine the requirements for the FDA`s DHF and the current and new requirements of EU`s MDR`s Technical Documentation - how to meet and document them. Their differing purposes/goals. Required and desirable contents. Areas requiring frequent re-evaluation/update. Similarities and differences, and future convergences and trends. Typical DHF Table of Contents. Technical File Documentation Table of Contents. The importance and usefulness of the old "Essential Requirements", now "General Safety and Performance Requirements". Structure of the "Declaration of Conformity"; N-B reviewed. Parallel approaches to development. The Device Master Record / Device History Record "tie in". Differing approaches to file inspections/audits by the U.S. FDA and Notified Bodies.

Areas Covered:-

• The U.S. FDA`s DHF, DMR and DHR
• The EU`s MDR and the Tech Documentation  File
• Development `Over Time` vs. a Product `Snapshot in Time
• DHF "Typical" Contents
• TD Expected Contents; CE-marking
• Design Control under 21 CFR 820.30
• Design and Development Planning per ISO 13485:2016  7.3
• Risk Management (ISO 14971)
• Human Factors / Use Engineering under IEC 62366-1

Background:-

What are U.S. FDA, EU MDD, and the new MDR requirements for DHFs, DMRs, DHRs, and TF/DD/TDs? Formats, content, and their commonalities, differences, interrelationships, and similarities.

Why Should You Attend:-

Global companies must meet different product design documentation for the U.S. and the European Union / Common Market. The cGMPs mandate Design Control and the Design History File (DHF). ISO 13485:2016 has identical requirements under Design and Development Planning. In order to sell globally, the EU`s CE-marking documentation is a requirement - the Technical FiIe/Design Dossier and now Technical Documentation. Currently, they serve different purposes and support different goals, but the TF/DD/TD now addresses components of the DHF. And the DHF has borrowed some features required in the TF/DD/TD. Being aware of the similarities and differences can further concurrent development/documentation, and/or updates to both.  And what are DMRs and DHRs` relationship to DHFs, TF/DDs?

Who Will Benefit:-

• Senior management
• Operations
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering

All personnel involved in the U.S. FDA-regulated and CE-marking environments.  Especially those involved in new medical device/combination product development, line extensions, and incremental product improvements; having to evaluate those changes in light of the DHF, and TD, and then document their decisions in harmony with regulations.