This "FDA GPSV Traceability Expectations" post is only available to Premium subscribers. See our Subscribe page for information on subscriptions.
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 . . .
Thank you for your interest! To view our Premium or Standards Navigator content, please click here to select the plan that best fits your needs.