This webinar will examine the existing and proposed requirements for the FDA`s DHF and the MDD`s TF/DD -- how to meet and document them. Their differing purposes / goals, required and desirable contents and areas requiring frequent re-evaluation / update will be discussed. Similarities and differences, and future convergences and trends will be examined. Typical DHF Table of Contents, Technical File or Design Dossier Table of Contents will be presented.
The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. We will also discuss parallel approaches to development, the Device Master Record / Device History Record "tie in" and Differing approaches to file audits by the U.S. FDA and a Notified Body.
Areas Covered in the Seminar: - The U.S. FDA`s DHF.
- The EU`s MDD and the Technical File / Design Dossier.
- Design Control vs. a Product `Snapshot in Time`.
- DHF "Typical" Contents.
- TF / DD Expected Contents.
- Parallel Approaches to Documentation -- Teams.
- The DMR and DHR.
- Future Directions.
- FDA and NB Audit Focus.
