Language Solutions for Medical Devices
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.
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
Document Translation
Software & Mobile App Localization
Website Localization
Cultural Adaptation & Transcreation
Voiceover
Subtitling
Testing
Multilingual DTP
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 Announces Rebranding of Commit Global, inWhatLanguage, and Balthasar Ltd.
ATLANTA, GEORGIA, UNITED STATES, May 15, 2024 – Translate.One, a distinguished global…
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…
Linguistic Validation Services in Life Sciences Localization
Among the multiple specialized localization services available in the Life Sciences sector…
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.
