US FDA and EU MDR Basic Medical Device Documentation Requirements

Duration 60 Mins
Level Intermediate
Webinar ID IQW20F0637

  • The US FDA / CGMP Design Control requirements, 21 CFR 820.30 and its deliverable documentation, the DHF
  • The EUs ISO 13485 7.3 Design and Development Planning requirements and the resulting File
  • Similarities and Differences
  • The changed EU landscape – the MDR requirements
  • The key “General Safety and Performance Requirements” Annex and proof of compliance
  • Typical / expected contents of both documentation “systems”
  • Two Device Classification Systems
  • Parallel approaches to documentation requirements
  • FDA and EU / NB Regulatory Inspection / Audit expectations

Overview of the webinar

This webinar will examine the requirements for the U.S. FDA's DHF -including its derivitive documents, the DMR and DHR. It will consider the European Union's new MDR Technical Documentation requirements. It will evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF / D&DP Table of Contents;  Technical Documentation Table of Contents; The importance and usefulness of the new "General Safety and Performance Requirements" of the EU MDR; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed;  Parallel approaches to development. Finally, the differing approaches to device file audits by the FDA and the Notified Body will be discussed.

Who should attend?

  • Senior management
  • R&D
  • QA / RA
  • Middle management
  • Manufacturing
  • Operations
  • Engineering
  • Marketing

Why should you attend?

One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean  Union requirements. As U.S. companies go global, they must meet different product design documentation.  The cGMPs mandate Design Control and the Design History File (DHF). EU / ISO 13485 mandate Design and Development Planning and File.  In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical FiIe or Design Dossier under the old EU MDD, and the Technical Documentation requirements of the new EU MDR.  Currently they serve different purposes, support different goals, but there are steps toward harmonization.  And how / where do the DMR and DHR fit?   Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both, and understand the new EU MDR documentation requirements.

Faculty - Mr.John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John 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 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, CAPA systems and analysis.  He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).  In addition, John has prior experience in military, government, electronics, and aerospace.  He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

06-03-2020 - US FDA and EU MDR Basic Medical Device Documentation Requirements.pdf


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