FDA published its Final Universal Device Identification Rule This includes that standalone software need only provide a means to display a human readable UDI. The full link to FDA’s web page on the UDI rule is at the link provided.
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.