Tag

verification
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...
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The latest ACM Journal has an interesting article on software verification at NASA JPL for the Mars Curiosity Rover at the link provided: Mars Code February 2014
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The link provided is to an article on Fuzz testing. This type of testing involves injecting bad data to challenge your applications and safeguards. This type of testing can be important to verify risk control measures and data integrity checks are verified. The name Fuzz testing is a fairly recent moniker for techniques that have...
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The pdf at the link provided is a reprint of an article entitled “Software Test Coverage” authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal and published in the Spring of 2003. AAMI-BIT-Software-Test-Coverage Article
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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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