FDA Physiological Closed Loop Workshop

FDA held a public workshop October 13-14, 2015 entitled “Public Workshop – Physiological Closed-Loop Controlled Devices”.Webcasts and other outputs from this workshop are avaialbel at the link provided.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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