FDA has provided a tool that allows creation of a premarket submission eCopy that is meets FDA requirements. The guide for this tool 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.