Your Trusted Partner in
Medical Device Localization
ISO 13485 Certified Translations
With a legacy of over two decades, Commit Global is your dedicated ally in navigating the intricate landscape of regulatory compliance for medical device manufacturers. We provide a comprehensive array 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/e-Learning Content
Our Services
We offer a comprehensive suite of services to meet your specific needs:
- Translation & Localization
- CCMS (Component Content Management System)
- Local Market Adaptation/Transcreation
- Functional & Linguistic Testing
- Multilingual IFU Desktop Publishing
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?
- 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.
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Broad-ranging expertise
Our specialization extends across various domains within the medical industry, including:
- single use devices (i.e. syringes, catheters)
- implantable (i.e. hip prothesis, pacemakers)
- imaging (i.e. ultrasound and CT scanners)
- medical equipment (i.e. anesthesia machines, patient monitors, hemodialysis machines)
- software (i.e. computer aided diagnostics)
- in vitro diagnostics (i.e. glucometer, HIV tests)
- personal protective equipment (i.e. mask, gowns, gloves)
- surgical and laboratory instruments
Why Choose 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.
