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MPO: PFMEA, ISO 14971, or Both for Medical Devices?

September 13, 2023

PFMEA ISO 14971 or Both for Medical Devices?

The September 6, 2023 online issue of Medical Product Outsourcing (MPO) features online exclusive, PFMEA, ISO 14971, or Both for Medical Devices, written by Dana Trousil, StarFish Mechanical Engineering Team Lead. Trousil is concerned with the questions whether the risk management tool PFMEA (Process Failure Modes and Effects Analysis) and how it fits into the development of medical devices, more specifically whether it aligns with risk management requirements outlined by ISO 14971.

Trousil first discusses elements of both PFMEA and ISO 14971 before comparing both more closely and defining application modes of PFMEA in the development and risk management of medical devices. He concludes, “Whether matching severity scores or not, the PFMEA is not a stand-in for overall risk management per ISO 14971, nor with the FDA regulations (21 CFR 820.30 – note that the FDA recognizes ISO 14971). That’s not to say the PFMEA shouldn’t be done—it’s a critical tool for determining manufacturing risks and creating a robust process.”

About StarFish Medical

Empowering Medtech Innovation ®
StarFish Medical is an award-winning, full-service Medical Device Design company offering design, development, and NPI manufacturing services based in Toronto and Victoria BC. Our Pathfinder™ process reduces wasted effort and increases success for medical device product definition, technical engineering, and product development. Prototype and volume production are delivered within an ISO 13485 certified Quality Management System, manufacturing and clean room facilities.

Empowering Medtech Innovation®.

StarFish Medical media contact:

Patrick Dean
[email protected]

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