Day

December 28, 2012
AAMI and FDA held a two day event Oct 2-3, 2012, as a summit on interoperability. 260 people attended. AAMI has authorized widespread distribution of the proceedings document from this event (see the link provided). Interoperability Summit 2012
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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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