IEC 82304 standard for healthcare systems NWIP

The new work item proposal (NWIP) for a standard for “Healthcare Software Systems – Part 1: General requirements” was approved in IEC. 82304-1 62A 839 CD

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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