On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal. In this episode, Naveen discussses:

- How FMEA's fit into ISO14971

- pFMEA's from External Partners and linking to risk files

- Simplifying Risk Management outputs for Audit

Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.

Show Notes and Links:

Let’s Talk Risk Newsletter: https://naveenagarwalphd.substack.com

Naveen’s Video on “When FDA Disagrees with your risk calculation method”: https://youtu.be/Y14_RTHMGqw

Warning Letter 1: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medtronic-inc-617539-12092021

Warning Letter 2: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/irhythm-technologies-inc-643474-05252023

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