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Software quality requirements being formed by task group organized by AAMI.

This article was originally published in The Gray Sheet

Executive Summary

SOFTWARE QUALITY REQUIREMENTS FORMED BY VOLUNTARY TASK FORCE will be considered by FDA as a possible template for 510(k)s for Class II medical software. At a March 27 Association for the Advancement of Medical Instrumentation meeting on device software, a 17-person informal task force was formed to draft a proposal that could lead to an internationally supported, risk-based device software quality standard. FDA plans to look into giving software manufacturers the option to use third-party certification of compliance with the standard as a basis for 510(k) clearance.
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