Posts tagged risk management video
Introducing Exeed’s New Webinar Series: Sharing Knowledge, Solving Problems

Exeed is happy to introduce our new webinar series, Sharing Knowledge, Solving Problems, hosted by Dr. Naveen Agarwal. These interactive webinars are an opportunity for the medical device community to come together and discuss questions and obstacles surrounding ISO 14971 and risk management.

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5 Elements of a Risk Management Policy

Clause 4.2 of ISO 14971:2019 requires the top management to define and document a policy for establishing criteria for risk acceptability. This policy must provide a framework to ensure that criteria are based on applicable national or regional regulations and relevant International Standards, stakeholder concerns and generally acknowledged state of the art.

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