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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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