Medical Device MDR following new FDA Guidance
Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems. He has been a consultant for the last10 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom, Netherlands, Canada, Poland, and Saudi Arabia. He specializes in design control, risk analysis, human factors, software validation, cybersecurity and supplier qualification/ control. Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include reporting requirements, recordkeeping requirements, report timing, clarification of the term “becoming aware” and clarification of reporting using form 3500A.
MDR regulation, reporting requirements, report timing, when do you "become aware", recordkeeping requirements, form 3500A
Course Level - Basic to Advance
Who Should Attend
- Development Engineers
- Production Management
- QA/ QC personnel
- Software developers
- Regulatory personnel
Why Should You Attend
FDA Medical Device Reporting (MDR) regulations require firms who have received complaints of device malfunctions, serious injuries, or deaths associated with medical devices to notify the FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers, and user facilities so that they can be detected and corrected quickly. 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 by integrating the new Guidance information into the existing regulation. a handout is a CAPA flowchart.