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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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