MDR Program conforming to New FDA Guidance

Speaker

Instructor: Edwin Waldbusser
Product ID: 705149

Location
  • Duration: 60 Min
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.
RECORDED TRAINING
Last Recorded Date: Apr-2017

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$349.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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Why Should You Attend:

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.

Areas Covered in the Webinar:

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

Who Will Benefit:

  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Regulatory Personnel
Instructor Profile:
Edwin Waldbusser

Edwin Waldbusser
Regulatory Consultant, Med Device Advisors

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). 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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