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Why Medical Device Brands Need Professional Translations
When it comes to saving lives, accessibility and accuracy in every form of communication are essential.
Subject Matter Experts
Translating information related to medical devices does not purely focus on medical translations. It needs experts with experience in legal, technical, and financial translations.
When it comes to translating for medical devices, you cannot take chances with an inexperienced translator or machine translations, as a seemingly innocuous medical mistranslation can have life-threatening and costly results.
Submit documents and presentations in the correct formats to foreign regulatory authorities for consistent standards and effective approval.
Language Services For Every Stage Of The Product Cycle
We offer end-to-end localisation of all content required at different stages of launching a medical device in the market.
Our Quality Promise
We conform to all the regulations and quality standards that are crucial in the medical device industry.
ISO 17100:2015 Certified
Our quality processes adhere to the European ISO Standard for Translation Services that includes expert linguist selection, accurate translation, adaptive localisation, proofreading and thorough quality analysis.
Our adherence to HIPAA guidelines ensures absolute security and privacy of all Protected Health Information (PHI) related to our clients that we possess in physical or electronic form.
As a GDPR compliant company, we ensure complete protection of your data and privacy. Our in-house compliance officer oversees all security measures.
Complete Data Confidentiality
All data shared with us remains strictly confidential at all times. We sign NDAs with all of our clients, vendors, temporary, and permanent employees to ensure this.
Market Your Medical Device In 180+ Languages
Help international companies and customers learn about your product and utilise it.
Our Swedish language services will help you see global success among 110 million native Swedish speakers.
Appeal to your Italian audience comprising of 64 million native speakers with our Italian language services.
ArabicArabic holds the official language status in 22 countries. Expand your business in Arabic-speaking regions with Arabic eLearning Localization services.
Secure your place in the fast-growing Thai market of 20.2 million native speakers with our Thai language services.
About one in five of the world’s population speaks some form of Chinese. Reach out to us and get quality Chinese language services.
Utilise our Spanish language services to appeal to your 480 million native Spanish speakers.
Help your brand reach out to 220 million native Portuguese speakers in 10 countries with our Portuguese language services.
Hindi is the native language of 322 million people across 15 countries. Expand your business in Hindi-speaking regions with our Hindi language services.
French is the second most studied language around the globe. Enable your brand to sound authentic in French with our French language services.
Did you know 13% of Europeans speak German as their first language? Target the European market with our German language services.
Our Experts Understand That Accuracy Is Paramount
Our certified linguists know the medical industry inside-out and are well aware of the technical and legal requirements.
- Post-graduate degree in medical and pharmaceutical translations
- Been translating for clinical and imaging software, medical devices, clinical trial protocols, informed consent forms, and SPCs since 2006
- Post-graduate degree in Neurology and Medical Genetics Linguistic Education
- Been translating for cardiology, healthcare, instruments, dentistry, genetics, biology, case reports, consent forms, and medical software manuals, since 2003
- PhD in Medical Chemistry
- Been doing medical and technical translations, authoring science books, and writing for popular science and journalistic publications, since 1995
Healthcare Brands That Became Successfully Multilingual With Us
Our clients vouch for our high-quality language services and exceptional customer support.
Stay On Top Of The Language Industry Trends
Translate By Humans is HIPAA and GDPR Compliant. Along with getting a mandatory NDA (Non-disclosure Agreement) signed by our translators, we also comply with the EU-US Privacy Shield Framework and follow all guidelines with respect to all personal data.
We provide medical translation services for all specialised fields, including medical devices and software (user guides, user manuals, pharmacovigilance reports), pharmaceuticals (drug labels and inserts, clinical reports, drug registration documentation), clinical trials (questionnaires, patient records, FDA submission forms), biotechnology (patient information leaflets, patent reports) and for critical documents like patient records, veterinary records, autopsy reports, marketing material and a lot more.
Yes, because of our extensive experience working with global clients, we are continually updated about the newest regulations and the standards set by various regulatory health authorities like EMA (European Medicines Agency), Health Canada, US FDA (Food & Drug Administration), CDSCO India (The Central Drugs Standard Control Organisation, MHRA (Medicines and Healthcare Regulatory Agency).
To meet the standards set by these national bodies, we employ only native-language experts with a solid medical background and a robust knowledge of regulatory affairs.
The European Union (EU) has a comprehensive list of requirements for launching or marketing your medical devices in the 27 European countries. To read what’s changed – in detail – give our blog a read.
Our services include:
1. Providing translations for all documents such as clinical trials, administrative records, and quality management system certificates required for regulatory assessments.
2. Implementing quick, accurate translations for documents like Instructions for Use (IFUs) which must be submitted before the CE (Conformité Européenne) marking that’s needed for conformity assessment.
3. Ensuring native-language translations for user manuals and product labels that the users can easily understand.
4. ISO 17100:2015 Certified and HIPAA Compliant translations to guarantee quality, precision and complete confidentiality.
Yes. All the translators working with Translate By Humans are medically qualified and meet the following credentials:
- A strong medical background and degree of specialisation in their medical field.
- 5+ years of experience in medical translation with knowledge of local and national regulatory requirements.
- Certification by an accredited translation or medical organisation.
- Native language expertise in their target language.
Is Your Medical Device Ready For Foreign Markets?
Need urgent translations for medical device information? We can do that!