This webinar will examine the requiements for the FDA's DHF and the current and new requirements of MDD/MDR's TF/DD/TD -- how to meet and document them. Their differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future convergences and trends. Typical DHF Table of Contents. Technical File/Design Dossier/Technical Documentation Table of Contents. The importance and usefulness of the "Essential Requirements"/"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 a Notified Body.

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. 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 differnt purposes, 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?

Webinar Takeaway

  • The EU's MDD and the Technical File / Design Dossier
  • Device Classification - U.S. FDA vs. EU MDD
  • Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies
  • DHF "Typical" Contents and Deliverables
  • The DMR and DHR / Lot / Batch Record
  • TF / DD Required Contents
  • Parallel Approaches to Documentation - Teams
  • FDA and NB Audit Focus

Who will Benefit

  • Senior Management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty John E Lincoln

Principal, J. E. Lincoln and Associates LLC. John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

Faculty John E Lincoln

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Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.