Software Compliance for PEMS in IEC 60601

UL Knowledge Service WorkshopSeptember 12, 2012 1:00 p.m. CST

Free Live Software Compliance for PEMS in IEC 60601 3rd Edition Webinar .
This webinar provides an overview of emerging requirements for software and programmable systems, specifically highlighting three common “pain points” of software certification; software of unknown provenance, risk management for software, and legacy devices.

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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