Instructor
John E Lincoln
This webinar will examine the existing and new EU and AI requirements for Technical Documentation - including derivative documents, the DMF and Lot Records (DHR).
It will consider the EU MDR's Technical File requirements, and evaluate the documents' differing (and similar) purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical Technical Documentation / File Table of Contents, The 510(k) and the; Technical File Table of Contents; The importance and usefulness of the "General Safety and Performance Requirements" (the old "Essential Requirements"); Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; AI use in the preparation and compilation of the Technical Documentation. Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
A popular subject, updated with the latest EU requirements for these foundational device documents, including AI content and preparation.. The EU's MDR mandates Design Control, Patient/User Risk Management (always), Usability / Human Factors Engineering (sometimes), and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File. Currently they serve different purposes, support slightly different goals, but they share more commonalities than differences.
This webinar addresses the device documentation requirements basically worldwide - with AI areas of concern, and how AI can assist in the preparation of such documentation. Being aware of the similarities and differences can further concurrent development and/or updates to both, especially in a harmonizing global market.
