Hardware Podcasts

127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal

Let's Combinate · 13 Mar 2024 · 48m

What this episode covers

Naveen Aggarwal, founder of Creative Analytic Solutions, explains that the QMSR final rule does not mandate ISO 14971 but requires risk management to be integrated into ISO 13485 quality systems, shifting FDA inspection focus from procedural compliance to risk-based decision-making. He highlights that small and mid-size companies face significant costs to transition, while large firms must overcome the challenge of linking risk outputs to design inputs and post-market data. Aggarwal advises against standalone risk policies, suggesting instead that companies integrate risk acceptability criteria into their existing quality policies and use clear, binary (red/green) risk matrices rather than ambiguous yellow zones.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Creative Analytic Solutions, FDA, JNJ
Also
ISO 13485, ISO 14971, QMSR

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