Medical Devices Global Translation Services for Medical Device Companies CE Marking • Clinical Studies • International Registrations • Marketing Campaigns • PMCF Surveys To withstand regulatory scrutiny, you need a serious translation partner who understands your business. That’s where Language Insight comes in. From IFUs and SSCPs to labels, clinical documentation, and global commercial launch materials, we help medical device companies translate regulated content with absolute precision, regulatory awareness, and a speed that gives you a competitive edge. Get a quote Why medical device manufacturers trust us Human translation & certification When it comes to medical device documentation, there is no margin for error. We work exclusively with specialist medical linguists who understand the regulatory landscape, delivering translations that are accurate, consistent, and built to help your product to succeed. We are ISO 17100, ISO 9001, ISO 18587 and ISO 27001 certified. Grow with us Whatever your language requirements, we are audit-ready and globally scalable – supporting the US, UK, and EU time zones via our international team. Whether you are launching your product internationally for the first time, or expanding your product family to a new set of markets, we will ensure that your documentation is as robust abroad as it is at home. We cover every regulatory lifecycle stage From pre-market and clinical trials to post-market and vigilance, we are a trusted provider for every step of the regulatory and commercial process. Pre-Market & Clinical Development ✔️ Protocols, ICFs, Investigator Brochures ✔️ Risk Management Files ✔️ Early IFUs Commercial & Market Growth ✔️ Websites, Content and SEO ✔️ Distributor Kits ✔️ Training Materials Post-Market Vigilance ✔️ PMS PMCF documentation ✔️ International Field Safety Notices ✔️ FSCA Recall documentation ✔️ Adverse event communication Market Access & Certification (EU, US & Global) ✔️ IFUs, Labels & Packaging ✔️ SSCPs for EU MDR ✔️ Declarations of Conformity ✔️ FDA 510(k), PMA & De Novo documentation Your data is in safe hands We know and understand the importance of security and confidentiality when providing Life Sciences translation services – especially as Digital Health solutions and Software as a Medical Device (SaMD) products become more established. We are committed to protecting your data, which has been proven by our ISO 27001 information security management certification. We are the sole users of our dedicated fibre leased broadband line for transferring all data and we ensure that all our files are returned to you via our secure client portal. We also have in‑office security procedures to guarantee all client data is safe and secure. To find out more about how our security systems benefit our clients, visit our security and confidentiality page. Explore our range of Medical Language Services: Diagnostics Read More Pharmaceuticals Read More Life Sciences Read More Get a quote If you’re interested in any of our language services and would like a free quote, please fill out our ‘get a quote’ form and a member of our Business Development team will contact you. Get a quote Here’s why you need us Sectors Our experience in transcription, translation, interpreting and other language services spans a range of sectors and specialisations. View sectors Our Teams Our teams are our greatest asset. We select all of our in‑house and in‑country experts for their experience and commitment to quality. Our Teams Quality Assurance Quality is at the core of everything we do. Without it, we can’t pride ourselves on being your trusted language partner. View quality assurance
