On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses:

The Anatomy of a Hazard

Hazard Source(HS), Initiating Mechanisms (IM) and Target-Threat Outcome (TTO)

Clifton Ericcson

How concepts/tools like these fit into the ISO14971 and ISO TR 24971 framworks

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.