Episode 9: Part 1: Talking Risk with Dr. Naveen Agarwal

The RA QA Café

Risk management is an essential requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. In the ninth episode of NAMSA’s RAQA Café Podcast, our hosts sit down with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC) to discuss valuable insights into Risk Management Systems and best practices for maintaining a Risk Management System.

Dr. Agarwal’s mission is to help elevate the collective capability in risk management throughout the medical device industry to accelerate innovation and launch highly safe and effective products for patients and doctors.

“...as a risk practitioner, the first conversation we need to have is creating an understanding of what we are trying to accomplish, because its required or its expected... ” – Dr. Naveen Agarwal (Principal and Founder, Creative Analytics Solutions, LLC)

Discussion topics include:

• Developing and maintaining a Risk Management System
• Having a quality mindset
• Product Development cycle

Helpful Links:

1. Naveen Agarwal, Ph.D. | LinkedIn
2. Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard | NAMSA
3. Industry Update: U.S. FDA Quality Management System Regulation | NAMSA
4. Let's Talk Risk!