Day

May 21, 1997
Nucletron Corporation 5/21/97 Brachytherapy products b. Specific versions of Veriflex software are ordered, but no SOPs exist which require verification of the version received. Furthermore, the Purchase Order database, used to check incoming components against part numbers, lists obsolete software versions under the current part number. 3. Failure to follow complaint procedures and to maintain...
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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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