MDR Program conforming to New FDA Guidance
Instructor:
Edwin Waldbusser
Product ID: 705149
- Duration: 60 Min
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
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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