Medical Device 2021 - A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19—Complaint Handling, MDR Reporting and Recalls

This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes.
Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas
Understand how to comply with complicated Complaint Handling, MDR and Recall requirements
Firms MDR reporting and FDA's handling of reports
Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
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. She has an intimate understanding of FDA regulatory and compliance issues