This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure.
Areas covered will include death, injury and mal-function reporting requirements, record keeping requirements, report timing, clarification of the term 'becoming aware' and clarification of reporting using electronic form 3500A.
Learning Objectives:
- MDR regulation
- Reporting requirements
- Manufacturer reporting requirements
- Written procedures
- Recordkeeping and public disclosure
- Specific issues and situations
- Malfunction reporting
- Report timing
- When do you "become aware?"
Why Should You Attend:
In the United States, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify 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 they can be detected and corrected quickly. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the MDR procedure to survive FDA inspections - avoiding FDA 483s and warning letters.
This webinar is aimed at helping device industry to understand, New FDA guidance which was issued in November 2016, explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in non-conformances. This new Guidance attempts to eliminate confusion.
Instructor
Edwin Waldbusser
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices.
His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.
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. He is also owner of www.meddeviceadvisors. com which offers over 80 easy to customize medical device Quality System SOP's.