ISO 13485:2016 Certified Translation Agency
Milestone Localization is ISO 13485:2016 certified for medical device translation services.
Translations Trusted by 400+ Global Companies
Significance of ISO 13485:2016 Certification
ISO 13485:2016 is an internationally recognized standard that establishes quality management system (QMS) requirements for organizations involved in the medical device industry. It ensures organizations follow strict regulatory and customer requirements, with a strong focus on risk management, process validation, and maintaining the safety and effectiveness of medical devices and related services.
Milestone Localization obtained ISO 13485:2016 certification on March 28, 2025, for its specialized translation and localization services in the medical device sector. This certification demonstrates Milestone Localization’s ability to maintain a comprehensive quality management system that consistently meets customer and regulatory requirements for medical device documentation.
Additionally, we have been ISO 17100:2015 certified since September 24, 2020, ensuring high-quality, industry-specific translation and localization services.
Importance of ISO 13485:2016 For Translation Agencies
Ensures High-Quality Medical Translations
ISO 13485 certification establishes a structured quality management system tailored to medical device translations. It ensures that translation agencies follow strict regulatory guidelines, implement rigorous quality controls, and minimize errors. This certification guarantees accuracy, consistency, and compliance in all medical translation projects, reducing risks for manufacturers and patients.
Accuracy and Consistency
ISO 13485 certification helps translation agencies refine their workflows to meet the strict requirements of medical device translations. It enhances process efficiency by implementing structured quality controls, reducing errors. This efficiency enables agencies to handle complex projects seamlessly, meet tight deadlines, and deliver high-quality, regulation-compliant translations with greater accuracy and reliability.
Enhances Client Trust and Satisfaction
Medical device manufacturers require translations that meet strict regulatory and quality standards. ISO 13485 certification assures clients that a translation agency follows rigorous processes to ensure accuracy, compliance, and risk management. This certification serves as proof of the agency’s commitment to delivering precise, high-quality medical translations that meet global regulatory requirements.
Opens New Market Opportunities
Medical device companies rely on accurate translations to enter new markets and comply with local regulations. ISO 13485:2016 certification assures manufacturers that their translated materials meet country-specific requirements, enabling smoother regulatory approval and faster market entry for their products worldwide.
Benefits of Working with an ISO 13485:2016 Certified Translation Agency
Guaranteed Quality and Consistency
Working with an ISO 13485:2015 certified translation agency ensures that the translations you receive meet the highest quality standards. The strict quality control measures mandated by ISO certification ensure that your medical device translations are precise, uniform, and free of errors.
Comprehensive Documentation and Traceability
ISO 13485:2016 certified translation agencies keep thorough records and track their processes carefully. This transparency ensures that you can track the progress of your projects and have access to all relevant documentation which is particularly beneficial for audits and meeting regulatory standards.
Consistent Communication and Support
ISO 13485-certified translation agencies follow structured communication protocols to ensure transparency and alignment with client requirements. They provide regular updates, prompt responses, and proactive issue resolution, ensuring that their medical translations meet strict regulatory standards.
Confidentiality and Data Security
ISO 13485-certified translation agencies implement strict security protocols to protect sensitive medical data. They ensure the safeguarding of confidential documents throughout the translation process. With controlled access and robust data protection measures, clients can trust that their information remains protected at all times.
Effective Risk Management
ISO 13485-certified translation agencies follow structured risk management protocols to identify, assess, and mitigate potential errors in medical translations. By implementing rigorous quality checks and preventive measures, they improve the overall reliability of medical documentation.
Industry-Specific Expertise
ISO 13485:2016 certification confirms that a translation agency has the necessary expertise to handle medical device documentation. It ensures that linguists, reviewers, and project managers are trained to work with complex medical terminology, regulatory guidelines, and technical content, reducing the risk of misinterpretation or errors.
98% OF OUR CLIENTS SAY THEY WOULD RECOMMEND OUR SERVICES TO A COLLEAGUE
“As a medical device company, we transitioned to EUMDR compliance in 2022 and needed translation on our IFUs in 22 international languages. We found Milestone Localization was best suited to do this work for us. Since then they have been our regular translation service provider with 100% on-time delivery of documentation.”
“Exceptional service. Quick. Exceeded my goals by a mile. Would definitely choose to work with them again.”
“We delighted to share our positive experience with Milestone Localization. Over the course of several projects, their translation services have proven invaluable to our team. Milestone Localization consistently demonstrates a high level of professionalism, and their commitment to delivering accurate and timely services is commendable. The team’s expertise shines through in every project they handle. Their skilled translators consistently provide top-notch results, making them trusted partner.”
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