How to evaluate Benefit-Risk Ratio for Medical Devices?

The evaluation of the Risk-Benefit ratio is key for Risk Management Files per ISO 14971 or when you build your Clinical Evaluation Report or when you need to define the risk of using a particular technology against another. I mean that risk-benefit evaluation is mainly what helps us to decide that our product is safe and performant.

So on this episode, Naveen Agarwal from Achieve will be my guest and help us understand the best way to measure your benefit-risk ratio.

Who is Naveen Agarwal?

Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D; to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links:

Naveen LinkedIn profile: https://www.linkedin.com/in/naveenagarwal

Exceed consulting solution: www.exeedqm.com

Achieve training: www.achievexl.com

Case study https://www.achievexl.com/benefit-risk-analysis-fda-case-study

Downloadable white paper from the FDA: https://www.fda.gov/medical-devices/products-and-medical-procedures/weight-loss-and-weight-management-devices