Day

March 25, 2006
This report was from an independent panel commissioned by Guidant corporation after Guidant received significant press for failure to take timely corrective action, including lack of clinician notification, of low probably known defects that could and did lead to deaths. This was focused in cardiac rhythm management products such as implantable pacemakers and defibrillators. The...
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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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