SW Development Environment Worksheet

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Use this as a starting point to gather information on the software development environment (and related information) as required in FDA's Guidance for Software Information to be included in open market submissions. It is only intended as a starting point to be tailored by those already familiar with the FDA guidances and current expectations.

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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

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

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