Day

February 10, 1997
Diagnostic Specialties 2/10/97Microplate processor 5. Your firm failed to qualify the [purged text] microplate processing instrument, as well as, the [purged word] Control Software and the [purged text] Software, for their intended use.
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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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