DHF, DMR, DHR, Technical File, Design Dossier – Implementing FDA CGMP and ISO 13485:2016 Requirements

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Jun 14, 2017
90 minutes
Product Description

Examine Existing and Proposed Requirements For the US FDA’s DHF, DMR and DHR Documents For CGMP and ISO 13485:2016 Implementation

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, along with the two different device classification schemes, updated to the new ISO 13485:2016 requirements, ‘How to address ISO 14971 Risk Management File’, and ‘IEC 62366 Usability Engineering File requirements.’

In this session, John will present an overview of the documents and explain what you need to know to comply with design control and meet the essential requirements. He will also address the regulatory document hurdles to get a new medical device to market under various regulatory agencies worldwide. This session will focus on the U.S. 21 CFR 820.30, and the European Union (and related) ISO 13485:2016 7.3 requirements.

Session Highlights

  • Areas requiring frequent re-evaluation/update
  • Similarities and differences
  • Future trends
  • Typical DHF table of contents
  • Technical file or design dossier table of contents
  • 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

Session Agenda

  • The U.S. FDA's (and ISO 13485’s) DHF / design and development file
  • 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
  • ISO 14971 File, and IEC 62366-1, -2 File
  • The DMR and DHR / lot / batch record (DHF “deliverables”)
  • Parallel approaches to documentation -- Teams
  • FDA and NB audit focus

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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