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RAQA Café
A podcast series that tackles trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry.
In the tenth installment of NAMSA’s RAQA Café Podcast, our hosts continue their conversation from the previous episode, “Talking Risk with Dr. Naveen Agarwal – Part 1,” with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC). This episode focuses on how to maintain a Risk Management System and shares industry best practices that our experts have acquired over their years in the MedTech sector. As a passionate advocate for risk management, Dr. Agarwal’s mission is to uplift the overall capability in risk management within the MedTech industry to accelerate innovation and launch highly safe and effective products for patients and doctors alike.
“A Risk Management System is not documentation…, make sure you have a process in place, make sure you have management responsibility defined, make sure you have competent people, … then we talk about how you document a risk management plan and a risk management file… The documentation is just an output of a Risk Management System” – Dr. Naveen Agarwal
Discussion topics include:
- Developing and maintaining a Risk Management System
- Having a quality risk approach
- Focusing on integrating risk management as a process and not a document
Helpful Links:
Naveen Agarwal, Ph.D. | LinkedIn
Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard | NAMSA
Industry Update: U.S. FDA Quality Management System Regulation | NAMSA
*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.