Language Solutions for Medical Devices

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ISO 13485 Certified Translations

Translate.One can help medical device manufacturers navigate the intricate landscape of regulatory compliance. We provide a comprehensive suite of language solutions meticulously tailored to meet all local requirements, empowering you to extend your influence and bring life-saving innovations to the global stage.

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Our Expertise Covers, but Is Not Limited To:

  • Operating, Maintenance, and Installation Manuals
  • Instructions for Use
  • Regulatory Compliance Documents
  • Software Applications
  • Package Inserts and Labels
  • Patents for Medical and Surgical Devices
  • Manufacturing Process Descriptions
  • Website/Marketing Copy
  • Training/eLearning Content

Our Solutions

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ISO 13485 Translations for Medical Device Safety

Our commitment to quality is reinforced by our ISO 13485 certification. But what does the ISO 13485 certification mean for our clients?

View our ISO 13485 Certificate
  • We are using a quality management system in our ISO 13485 translation process to prevent misuse and ensure that your medical devices are safe for their intended purpose.

  • We are using strict linguist selection criteria for ISO 13485 medical device translations. You can rest assured that your projects are handled by qualified professionals that have extensive experience in Medical Device translations and follow strictly defined processes which leave minimum margin for mistakes and customer complaints.

  • We have an identification, traceability, and version control process in place to ensure that product safety and accountability can be fully achieved.

Broad-Ranging Expertise

Our specialization extends across various domains within the medical industry, including:

  • single use devices (i.e. syringes, catheters)
  • in vitro diagnostics (i.e. glucometer, HIV tests)
  • implantable (i.e. hip prothesis, pacemakers)
  • personal protective equipment (i.e. mask, gowns, gloves)
  • imaging (i.e. ultrasound and CT scanners)
  • surgical and laboratory instruments
  • medical equipment (i.e. anesthesia machines, patient monitors, hemodialysis machines)

What Makes Our Services Stand Out

Why Us?

  • Expertise in Medical Terminology

    Our translators specialize in medical terminology, ensuring that every nuance of your content is accurately translated. We bridge the language gap with a deep understanding of the regulatory landscape and industry standards.

  • Regulatory Compliance

    Navigating the complex world of medical device regulations is a challenge. Our team is well-versed in global regulatory requirements, ensuring that your localized content complies with all relevant standards and guidelines.

  • Dedicated Project Managers

    A dedicated project manager will be assigned to your project, providing you with a single point of contact. They will work closely with you to understand your specific needs, timelines, and any regulatory nuances.

  • Quality Assurance

    We adhere to rigorous quality assurance processes, including multiple rounds of review and testing. This ensures that your localized content not only meets but exceeds your expectations.

  • Insights

  • Translate.One Acquires Enable2

    Translate.One Acquires Enable2, Enhancing Language Support Services Globally

    ATLANTA, GEORGIA, UNITED STATES – June 10, 2024 - Translate.One, a distinguished…

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  • Translate.One Announces Rebranding of Commit Global, inWhatLanguage, and Balthasar Ltd.

    Translate.One Announces Rebranding of Commit Global, inWhatLanguage, and Balthasar Ltd. 

    ATLANTA, GEORGIA, UNITED STATES, May 15, 2024 – Translate.One, a distinguished global…

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  • Translate.One Honored as Silver Stevie® Award Winner in 2024 American Business Awards®

    ATLANTA, GEORGIA, UNITED STATES– April 26, 2024 – Translate.One is proud to…

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  • Testimonials

    What Our Clients Have to Say

    At Translate.One, our clients’ satisfaction is our utmost priority. We take pride in delivering exceptional translation services that exceed expectations. But don’t just take our word for it – hear what our clients have to say.

      Great professionalism and communication!

      Marketing and Advertising Company

      I’ve been utilizing Translate.One for translation services for almost 5 years and have had nothing but positive experiences. They’ve always surprised me with their swift response time, and have saved me on more than a few occasions when I needed to turn something around quickly. They have proven to be a reliable and valuable supplier partner. Highly recommend!

      Medical Device Company

      We rely on Translate.One to provide high quality translation services in more than 10 languages. They are always deliver on time and on budget.

      Software Company

      Work of high quality, even with terminology terms, responsibility towards deadlines, project manager understands the needs of the client.

      Consulting Firm

      The right partner for medical technical translation services.

      Medical Equipment Company

      A reliable, fast and responsive company!

      Consultancy Firm

      Outstanding service from start to finish! We really felt like your team put a lot of consideration and time into the project – our best interest was always kept in mind. Completion time frames were always as promised.

      Wellness Company

      Translate.One’s delivery of localization services is simply outstanding – from document/website conversion, on-site subject matter experts and voice-over talent they really offer a broad range of services to support our worldwide customer base.

      Technology Company

      We had an awesome experience with the whole team. Everyone was really easy to work with and they delivered a high-quality translation in a record time. I particularly enjoyed their extreme attention to detail.

      Video Production Company

      The translations I have received from Trustpoint.One, now Translate.One, are always reliable, competitively priced and delivered on time. The project manager that I work with is always attentive and responsive.

      Plastics, Glass and Aluminum Manufacturer

      I run a nationwide immigration practice. I have critical documents coming in from all over the world in all sorts of languages. In my business you need quick efficient and accurate translations. Translate.One. aka Trustpoint.One has never let me down.

      National Immigration Group

      I always rely on Translate.One as my final proofread/edit of TEQ magazine. I sleep better with an independent set of eyes on TEQ before I go to press. I’m always impressed with the speed and quality of work.

      Pittsburgh Technology Council

    Book a Meeting, Request a Quote or More Info!

    Translate.One is a B2B company and unable to offer help with personal documents.

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