FDA Medical Device eCopy webpage updated

The FDA maintains a webpage of resource at the link provided s for their eCopy program for medical device submissions. This addresses IDEs, premarket submissions and registration and listing. FDA also provides several tools for formatting and validating eCopy submissions.

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.

office@softwarecpr.com

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