Medical Device Translation Service & Tools

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 for the medical device industry and has its own patented risk management process.  Read more on their website:  Transperfect.

EnCompass content solutions are designed to address all of the content needs of today’s medical device manufacturer, from start-up to global enterprise. Beginning with patented risk management from our Crimson Life Sciences division, through advanced content management technology from sister divisions Vasont Systems, Astoria Software, and Translations.com, and including the global resources of TransPerfect Translations, EnCompass offers the first comprehensive portfolio of integrated content services and technologies for the medical device industry.

Our staff has years of experience including certified auditors and instructors for public training courses on Quality Systems, Design Control and Software Validation with FDA co-instructors. Our staff has been involved in routine internal auditing as well as in response to significant FDA enforcement actions and some have come from FDA. Our staff has performed internal training at FDA and Health Canada and has authored related standards.  Leave us a message below if you would like to discuss translations and localization software verification and validation.

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.