AAMI TIR 80001-2-5 Distributed Alarm Systems

ANSI/AAMI/IEC TIR80001-2-5:2014 “Application of risk management for IT-networks incorporating medical devices Part 2-5: Application guidance: Guidance on distributed alarm systems” has been published. Sherman Eagles of SoftwareCPR was a co-chair for this.

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

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.