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Join NAMSA for its conversational podcast series, “RAQA Café,” dedicated to trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry. In each episode, our hosts sit down with industry-leading experts to discuss the latest challenges facing MedTech developers and best practices to overcome these hurdles.

TOPIC

RELEASE DATE
Updates on the IVDR April 24, 2024
Risk Management, Clinical Evidence and Post-Market Reporting March 6, 2024
Effective Communication with Notified Bodies January 31, 2024
Talking Risk with Dr. Naveen Agarwal-Part 2 December 13, 2023
Talking Risk with Dr. Naveen Agarwal-Part 1 November 27, 2023
Clinical Investigations: Collecting Proof That Your Device is Safe and Effective September 14, 2023
The EU IVDR: What Do You Need To Know? August 10, 2023
Compliance Pitfalls of In Vivo Studies-How to Learn from the Mistakes of Others July 12, 2023
RAQA Café Live! – RAPS EU Convergence and Effective MDR-Compliant Periodic Safety Update Reports June 28, 2023
IVD Special – Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations June 14, 2023
Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations May 10, 2023
Refuse to Accept Policy and the Future of FDA Submissions April 12, 2023
Choosing the Right Consultant March 15, 2023

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