Reprint of AAMI BIT Journal Test Coverage Article

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

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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