FDA Issues Revisions to Recognized Standards

FDA issued the annual update to its list of recognized standards. The full list is at the link provided. While there have been no changes or additions to the general medical device software standards, there are some additions to IVD related computer and laboratory information systems, networking, and interface standards, as well as withdrawals and updates to several of the IEC 601 series standards.

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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