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.
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
Course Provider
Edwin Waldbusser,
