![]() ![]() In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical Documentation (TD). The cGMPs mandate Design Control and the Design History File (DHF). companies go global, they must meet different product design documentation. Why should you Attend: One of our most popular webinars, continuously updated with the latest U.S. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed. Required and desirable contents will be discussed.Īlso considered: Areas requiring frequent re-evaluation / update Similarities and differences Future trends Typical DHF Table of Contents Technical documentation 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 changes and/or N-B reviewed Parallel approaches to development. ![]() It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes.
0 Comments
Leave a Reply. |