Talking Risk with Dr. Naveen Agarwal – Part 2

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

Let’s Talk Risk!

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Meet the Speakers

Naveen Agarwal, PhD; Principal and Founder of Creative Analytics Solutions, LLC

Naveen Agarwal has developed risk management systems from the ground up and helped multiple clients integrate them within their existing quality management system, without disrupting their current operations. He has an extensive multi-year experience in the Ophthalmology space with growing experience in both the Orthopedic and Cardiovascular space.

His approach to building and implementing these systems is grounded in a deep understanding of regulatory requirements and state-of-the-art practices. At the same time, he rolls up his sleeves, and works hand-in-hand with clients to help them execute. Whether you are starting from scratch as a startup, or trying to tweak your current process in a large multi-billion operation, he can help you find creative solutions to your most challenging problems.

Linford Leitch; Former Regulatory Consultant, NAMSA

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.

Richard Granquist; Senior Quality System Consultant, NAMSA

Rich Granquist has 17 years of experience in the medical device industry and has spent extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.

Rich started in the medical device industry as a Microbiologist focusing on preclinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. He spent several years as a Quality Engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a Quality Systems Consultant. Over his 16 years in the medical device industry, he has participated in numerous AAMI ISO standards committees and currently sits on the AAMI working groups for AAMI ISO 14971, AAMI ISO/TR24971, AAMI ISO 13485 and AAMI ISO 15223.