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Complying with ISO 14971:2019 Blog Feature
Ben Higgitt

By: Ben Higgitt on August 11th, 2020

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Complying with ISO 14971:2019

Medical Device | Risk | Risk Management


The below is an excerpt of the article originally published on MDDI.

FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks.

Some product teams still believe that FMEA “checks the box” for risk management. However, since the widespread adoption of ISO 14971, most companies treat FMEA correctly as a component of a larger risk management system, but they are often still performed in the same tool/process. The challenge is how to separate these functions to create the most effective risk management system possible.

To read the full article, including an overview of FMEA and Risk Analysis, as well as detailed approaches for integrating FMEA with Risk Management, please visit MDDI.


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About Ben Higgitt

Ben Higgitt is the Engineering Technical Lead at Cognition Corporation, a SaaS company that develops product development and compliance solutions for the life sciences industry. He is passionate about aligning technology with constantly evolving standards and regulatory requirements and works closely with customers, industry leaders, and regulatory experts to challenge historical precedent and design solutions that go beyond today’s requirements.