Hardware Podcasts

098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi

Let's Combinate · 16 Aug 2023 · 40m

What this episode covers

Bijan Elahi, a Technical Fellow and Medtronic corporate Advisor on safety risk management, explains the fundamental differences between MedTech and Aerospace risk management, noting that MedTech balances risk against benefit while Aerospace focuses on elimination. He details the challenges of quantifying risk using ISO 14971, advocating for quantitative methods over qualitative guesswork to provide objective evidence of safety. Elahi also discusses the regulatory requirements of the EU MDR, specifically the 'as far as possible' (AFAP) standard, and how companies determine when risk reduction is sufficient without adversely affecting the benefit-risk ratio.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Medtronic, NASA
Also
ISO 14971, EU MDR, ISO 31000, IEC 62304

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