Hardware Podcasts

073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal

Let's Combinate · 22 Feb 2023 · 19m

What this episode covers

Naveen Agarwal of Creative Analytics Solutions explains the 'Anatomy of a Hazard' using Clifton Ericcson’s HS-IM-TTO model to clarify ISO 14971 risk management for medical devices. He argues that hazards are non-linear system properties rather than simple linear sequences, requiring a distinction between hazard source, initiating mechanisms, and target-threat outcomes. Agarwal advocates for separating failure analysis (FMEA) from hazard-harm analysis to manage complexity and improve completeness in risk files.

Most relevant to

established companies

Topics

Mentioned

Companies
Creative Analytics Solutions
Also
ISO 14971, ISO TR 24971, Clifton Ericcson, FMEA

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