DHFs, DMRs and Technical Document Files under U.S. FDA and EU's New MDR

John E. Lincoln

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This training program will provide regulatory requirements (US) of 21 CFR Section 820.30 (Design Control) and  820.180 (Records) for the medical device industry, ISO 13485  7.3, and the new EU MDR (replacing the MDD).  We will illustrate the same with examples. It will furnish details on what each element should address, how and why.

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).  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, but there are similarities.  Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.

 This webinar will examine the requirements for the U.S. FDA's DHF and the ISO’s Design and Development File  -- including their deliverables, including the DMR and DHR.  It will consider the European Union's MDD TF/DD requirements currently being phased out and the new MDR Technical Documentation being phased in.  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 Table of Contents;  Technical Documentation Table of Contents;  The importance and usefulness of the old "Essential Requirements" and new "General Safety and Performance Requirements";  Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed;  Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

The webinar includes a challenges and conclusion session as well.

Learning Objectives:

  • Detailed information to help you gain a better understanding of the requirements regarding 21 CFR Section 820.30 and related CGMPs
  • How does 21 CFR Section 820.30 relate to ISO 13485:2016  7.3 Development Requirements comparison between both
  • Details regarding the different hierarchy of documentation between US and EU
  • Supplier metrics you can implement
  • Understand some of the challenges

Areas Covered in the Webinar:

  • FDA Regulatory Background
  • Intent of 21 CFR Section 820.30 (Design Controls; 10 steps)
  • ISO 13485:2016 7.3 Design and Development Planning, 10 steps
  • Proof of Compliance and Intellectual Property:  The DHF / D&DF
  • Important contents of the Files
  • Risk Management per ISO 14971
  • Human Factors / Use Engineering per IEC 62366-1
  • The “Start Date”
  • Key Definitions
  • The EU's MDD and the Technical File / Design Dossier
  • EU’s old “Essential Requirements”
  • The new EU MDR's Technical Documentation
  • EU’s new “General Safety and Performance Requirements”
  • US and EU’s different device Classification systems
  • Type of Warning Letters and Deficiencies Related to Design Controls
  • Challenges

Who Will Benefit:

  • Regulatory Compliance Professionals
  • Quality Assurance Professionals
  • Design Control Professionals
  • Regulatory Affairs Professionals
  • Regulatory Compliance Professionals
  • R&D
  • Manufacturing Engineers
  • Medical Device Project Managers
  • Process Development Personnel
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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. 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 published 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. John is a graduate of UCLA

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