Day

October 16, 2006
Recipient: Patterson Technology Center Inc. Product:EagleSoft software Date:10/24/06 Failure to maintain procedures for receiving and evaluating complaints by a fomally designated unit; failure to establish and maintain adequate procedures for implementing corrective and preventive action; failure to establish and maintain adequate design control procedures to ensure design procedures address the planning, inputs, outputs, review, verification,...
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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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