Day

July 7, 2000
PRODUCTComponents and Distribution Information System (CDIS) Stand Alone Blood Bank Software. Recall #B-1094-0. REASON Blood bank software contains a defect that results in not all products produced from a donation receiving the special donation properties that are applicable to donation. CODE All versions up to and including version 1.1.1. MANUFACTURER Information Data Management, Inc., Rosemont,...
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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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