Day

March 2, 2002
“Lessons from 342 Medical Device Failures” by Dolores R. Wallace and D. Richard Kuhn of NIST examines software related recalls for medical devices and their possible causes and preventive measures. IEEE-NIH_CBMS_Safety_Model-13
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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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