U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Mar 28, 2017
90 minutes
Product Description

Basic Documentation Requirements for Compliance under U.S. FDA and EU MDD


This webinar by expert speaker John E. Lincoln will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes/goals, as well as the two different device classification schemes.

John will present an overview of the basic activities and documents to show compliance to design control and meeting “essential requirements” in addressing the regulatory document hurdles to get a new medical device to market. He will cover requirements under various regulatory agencies worldwide, with emphasis on the U.S. and the European Union. John will also answer basic questions device manufacturers, start-ups, investors and other stakeholders have on basic medical device development documentation and major milestones to get a new medical device to market in the U.S. and EU.

Session Highlights:

  • The U.S. FDA's (and ISO 13485’s) DHF
  • The EU's MDD and the Technical File / Design Dossier
  • Device Classification - U.S. FDA vs. EU MDD
  • Design Control vs. a Product 'Snapshot in Time'
  • DHF "Typical" Contents
  • The DMR and DHR / Lot / Batch Record (DHF “deliverables”)
  • Parallel Approaches to Documentation - Teams
  • FDA and NB Audit Focus
  • Areas requiring frequent re-evaluation/update
  • Similarities and differences
  • Future trends
  • Technical File or Design Dossier
  • The importance and usefulness of the "Essential Requirements"
  • Structure of the "Declaration of Conformity"
  • Self-declaring or N-B reviewed
  • Parallel approaches to development
  • Differing approaches to file audits by the FDA and the Notified Body

Who should attend:

  • R&D
  • Engineering
  • QA / RA
  • Operations
  • Mid- and Senior-level Management
  • CEOs and CFOs
  • Sales and Marketing
  • Purchasing
  • Other medical device manufacturing stakeholders

At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

John E. Lincoln

John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 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...   More Info
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