Medical Device 2020 - A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19—Complaint Handling, MDR Reporting and Recalls

Medical Device Reporting (MDR) and recall compliance are critical to the continue survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions
This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes.
Understand how to comply with complicated Complaint Handling, MDR and Recall requirements
Firms MDR reporting and FDA's handling of reports
Speaker:
Rita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries