FDA Report on Non-Device Software Functions

FDA issued a report entitled “REPORT ON NON-DEVICE SOFTWARE FUNCTIONS: IMPACT TO HEALTH AND BEST PRACTICES – DECEMBER 2018.” This report contains findings on five software functions excluded from the device definition by the 21st Century Cures Act. The FDA found these software functions have more benefits than risks to patient safety and health. The report also details best practices related to implementation and training that could promote safety, education, and competency. The full report is at the link provided.

21st Century Cures Report on Non-Device Software Functions

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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