Reprint AAMI BIT Journal Mulilingual Risk Article

The pdf at the link provided is a reprint of an article entitled “Risk-Based Validation of Multilingual Medical Devices” co-authored by Alan Kusinitz, Managing Partner of SoftwareCPR, and Kai Simonsen of the Crimson Life Sciences division Transperfect Translations for the AAMI Biomedical Instrumentation and Technology journal and published in the Summer of 2007.
Reprinted with permission from Biomedical Instrumentation & Technology, a peer-reviewed journal by the Association for the Advancement of Medical Instrumentation. Visit www.aami.org to learn more about AAMI or to view BI&T’s current issue. This article discusses risk management considerations for translations and localization of medical devices intended for use in multiple countries.

AAMI Localization Risk Validation Reprint 0807

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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