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.

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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