IVD Electronic 510(k) Submissions

The FDA Center for Devices and Radiological Health Office for In Vitro Diagnostic Devices has been promoting use of electronic 510(k)s. The link above provides information as well as links to FDA’s CeSUB esubmitter software and user manual.

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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