Reprint of Sensible Testing Article

The pdf at the link provided is a reprint of an article entitled “Sensible Software Testing” with the permission of the author Sean Beatty of High Impact Services. Mr. Beatty was a member of the working group that developed AAMI TIR32: Medical Device Software Risk Management. He is very experienced in embedded programming and this article focuses on white box testing from that perspective.

Sensible Software Testing – SBeatty

What’s New

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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