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translations
In SoftwareCPR’s experience, translations and localization of user interfaces and labeling of medical devices for distribution in a variety of geographic regions can be challenging and can present safety issues if not properly handled.  Alan Kusinitz of SoftwareCPR® co-authored an article on localization risk management with one of the large companies that provides such services...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Crimson Life Sciences which performs language translations for labeling and user interfaces was assessed by Underwriters Laboratory for conformance with the ISO 14971 Medical Device Risk Management standard. The summary of the audit results is available at this link...
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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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