Medical Devices Localization Services

Medical device translation services are at the core of life sciences. Healthcare practitioners everywhere must be able to recommend patient-focused therapies and use medical devices properly no matter the language they speak. Trusting Pangea Global with your medical device translation projects is trusting a team of subject-matter experts. We keep abreast of the latest regulatory changes affecting the medical devices industry – from the EU MDR and IVDR to the FDA – to ensure that all the materials we translate are fully compliant with the local norms weighing on the device manufacturers' shoulders.

  • EU MDR & IVDR
  • 75+ languages
  • ISO 17100
  • 4.9 ★

Quick quote

    Trusted by global brands

    Medical device and life sciences manufacturers

    Why medical device teams choose Pangea

    • Expert medical device translations

      Trusting us with your medical device translations means trusting a team of dedicated linguists, proofreaders, revisers, terminologists and industry natives able to tackle projects of any complexity, spanning medical device user manuals, catheters & IVs, anaesthesia, ventilation, patient monitoring, radiology, cancer screening, and a lot more.

    • Quality & speed go together

      We think fast and slow when translating your medical device content. Whether it is a patent application, a marketing brochure, leaflet or white paper, you can count on us to translate it quickly and accurately.

    • Regulatory compliance

      We keep abreast of the latest regulatory changes affecting the medical devices industry – from the EU MDR and IVDR to the FDA – to ensure that all the materials we translate are fully compliant with the local norms weighing on the device manufacturers' shoulders.

    Regulatory frameworks

    Standards we follow

    When we translate medical device documentation, we are on a mission to deliver laser-focused translations so that healthcare professionals and regulators around the world can safely use and approve your equipment.

    • EU MDR
    • EU IVDR
    • FDA requirements
    • ISO 9001: 2015
    • ISO 17100: 2015
    • Technical documentation
    • Product labelling
    • Clinical evaluation reports

    Medical device document types

    Materials we translate

    • User manuals

      User manuals and instructions for use for healthcare professionals and patients.

    • Calibration manuals

      Calibration manuals and maintenance documentation.

    • Technical specifications

      Technical specifications for device approval and deployment.

    • Product labelling

      Product labelling compliant with local regulatory requirements.

    • Patents

      Patent applications and intellectual property documentation.

    • Marketing materials

      Marketing brochures, leaflets and white papers.

    • Case studies

      Case studies and clinical evidence summaries.

    • Clinical trials

      Clinical trials and scientific documentation relating to medical equipment.

    Crossing all the T’s of medical device translation

    When we translate medical device documentation, we are on a mission to deliver laser-focused translations so that healthcare professionals and regulators around the world can safely use and approve your equipment.

    • Spot-on

      We are a team of over 600 vetted translation professionals and native speakers of 75+ languages, experienced in translating medical device documents.

    • On your terms

      We take pride in offering the fastest turnaround in the translation industry, with a tailored workflow so you can go to market as planned. We stick to your terms and deadlines.

    • High-standard

      Complying with the ISO 9001: 2015 & ISO 17100: 2015 standards, our medical device translation services are among the best in the industry.

    • By your side

      We don’t work in isolation. Once we agree on the terms, your dedicated project manager will be in contact with you, keeping you up-to-date with the progress.

    Service options

    Translation, revision and LQA

    • Translation & revision

      Medical device translation services include the translation, revision and linguistic quality assurance of technical and scientific documentation relating to medical equipment.

    • Subject-matter experts

      All our translators are native speakers of the languages they translate to and from and have a solid background in the medical device industry.

    • Dedicated project management

      Your dedicated project manager keeps you up-to-date with the progress throughout the project.

    How it works

    Medical device translation in four steps

    1. Scope

      Share device documentation, target markets and regulatory requirements.

    2. Quote

      Receive a clear per-word or per-project quote for your language pairs.

    3. Translate & revise

      Native medical device linguists translate; revisers perform linguistic quality assurance.

    4. Deliver

      Receive compliant documentation on your timeline with project manager updates throughout.

    What clients say

    Results that scale

    Medical device translation at a glance

    • 600+

      linguists

    • 75+

      languages

    • 24h

      typical quote turnaround

    Integrations

    Secure workflows for technical documentation

    Accreditations

    ISO 9001: 2015 and ISO 17100: 2015 certified

    Compliance & security

    ISO-certified medical device translation

    • ISO 9001: 2015

      Complying with the ISO 9001: 2015 standard, our medical device translation services are among the best in the industry.

    • ISO 17100: 2015

      Complying with the ISO 17100: 2015 standard for translation services with revision and LQA.

    • Confidentiality

      We handle medical device documentation with strict confidentiality and GDPR-compliant data handling.

    FAQ

    Medical device translation, answered