Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
Medical Device Design: Determining if a Risk Requires Mitigation
A risk management plan documents how a project team will identify and evaluate potential risks with a product. The plan outlines the process and the criteria the team will use to determine if mitigation is required for a particular risk. This document becomes part of the complete Design History File (DHF). This activity is an integral part of Ximedica's product development process to satisfy the requirements of HE-75, 21 CFR 820.30(g), and ISO 14971:2007, (i.e., the guidelines and regulation published by the FDA and the international standard for risk management in the medical device industry).
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Posted on Oct 31, 2011