62304 Conformance Checklist Tool

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62304 can provide an excellent framework from which to design a software process for medical device, medical mobile app, and/or HealthIT software.  62304 was created specifically for this type of software - it was not just borrowed from another industry.  It is a recognized FDA consensus standard and establishes much of what is expected for SDLC activities and documentation.

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About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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

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