Hardware Podcasts

095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal

Let's Combinate · 26 Jul 2023 · 43m

What this episode covers

Naveen Agarwal of Creative Analytics Solutions explains that ISO 14971 does not mandate FMEA, arguing that industry misuse of the tool for compliance rather than engineering reliability creates gaps in patient safety. He distinguishes between the 'one-to-many' nature of FMEA and the 'many-to-one' reality of patient harm, advocating for the use of Fault Tree and Event Tree analyses to bridge this gap. Agarwal emphasizes that severity in FMEA should prioritize engineering outcomes beyond just safety, and that process FMEAs must link directly to design FMEAs to ensure comprehensive risk control.

Most relevant to

established companies

Topics

Mentioned

Companies
Creative Analytics Solutions, Medtronic, iRhythm Technologies
Also
ISO 14971, ISO 14971 TR 24971, FDA

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