FDA Device eSubmission Pilot

The FDA is accepting requests to participate in its Medical Device eSubmission pilot program. This is only open for devices being submitted to ODE’s Division of Cardiovascular Devices Cardiac Diagnostic Devices Branch or Peripheral
Interventional Devices Branch. This will be interactive to evaluate the process/tools and the Refuse to Accept screening will be waived for participants. Deadline for requests to participate is September 30, 2014.

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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+1-781-721-2921
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