Professional Medical Device Translation Services

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:   

1. A strong medical background and degree of specialisation in their medical field.
2. 5+ years of experience in medical translation with knowledge of local and national regulatory requirements.
3. Certification by an accredited translation or medical organisation.  
4. Native language expertise in their target language.