Jan

2020

FDA GPSV Traceability Expectations

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Going way back to the late 1990's, FDA had an expectation that safe and effective software would require a well thought out development lifecycle that includes many activities designed to ensure the correctness and robustness of all software that was part of the medical device. A key guidance document was created known as the General Principles of Software Validation, or GPSV for short. One method that . . .

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About the author

Brian Pate

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!

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FDA GPSV Traceability Expectations

Brian Pate

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