Medical Device Label Translation

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Guidance on Medical Device Patient Labeling | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-labeling

When translating the professional label into lay language, take care to ensure that it does not alter the intent of the indications, contraindications, warnings and precautions, or other parts of...

Life Sciences Translation and Life Sciences Marketing

https://www.lionbridge.com/life-sciences/

REGULATORY TRANSLATION Drug Labeling & Validation We translate and validate primary, secondary, and/or tertiary drug labels for investigational drugs, …

Device Labeling | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Device Labeling | FDA Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops …

European Language Translation Requirements for Medical …

https://medenvoyglobal.com/european-language-translation-requirements-for-medical-device-labeling-ifus-and-software/

Shown below are the medical device language requirements for devices sold in European countries. This includes all EU and EEA countries plus a few others. This …

5 Translating Tips for Medical Device Labeling

https://www.languageintelligence.com/post/5-translating-tips-for-medical-device-labeling

Translation & Localization Multilingual DTP Voice-over & Subtitling Transcription BY SPECIALIZATION Manufacturing Software & Technology Life Science Market Research …

Translation Requirements for International Medical …

https://www.morningtrans.com/translation-requirements-for-international-medical-device-labeling/

Do you know the medical document translation and labeling requirements in the countries where you plan to sell your medical device? What about the difference between labels, …

Worldwide Language Requirements for …

https://www.argosmultilingual.com/blog/worldwide-language-requirements-for-medical-device-translations

When considering your language requirements for medical device translations, you’ll need to consider two different categories of translations – submission documents and labeling …

How to Create a Label as per EU MDR 2017/745?

https://easymedicaldevice.com/create-a-label-eu-mdr-2017-745/

“label” means any written, printed, or graphic information appearing either on the device itself or on the packaging of each unit or on the packaging of multiple devices. …

Various Standards Governing Translation for Medical …

https://www.daytranslations.com/blog/standards-medical-devices-translation/

The translation for medical devices is big business. In the EU, the medical device business is worth 95 billion euros annually and provides employment for about …

Repackaging of a medical device or translated its labelling

https://mdrregulator.com/news/certificate-importer-distributor-repackaging-translated

That system must include procedures which ensure that the translation of information is accurate and up-to-date and, as regards repackaging, that the activities are performed …

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