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FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion.


This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. It includes reporting requirements, record keeping requirements, report timing, clarification of the term “becoming aware” and clarification of reporting using the form 3500A.


  • Reporting requirements
  • Record keeping requirements
  • Report timing
  • Clarification of what “becoming aware” means
  • Clarification of reporting using form 3500A


  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Regulatory Personnel


Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patients). He has been consulting in the areas of design control, risk analysis, and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

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