Day

September 9, 1999
The New England Biomedical Discussion Group held a half-day seminar on Risk Management. Alan Kusinitz of SoftwareCPR gave a presentation on Software Risk Management. The newsletter summary of the seminar is at the link provided: Intro to Risk Management Article
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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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