Milestone Localization Achieves ISO 13485:2016 Certification for Medical Device Translations
[SOLIHULL, UK, 28 March 2025] – Milestone Localization, a leading provider of translation and localization services, is proud to announce that it has achieved the ISO 13485:2016 certification, an internationally recognized standard for quality management systems specific to the medical device industry.
This achievement highlights the company’s dedication to delivering the highest quality translation services for medical device manufacturers and healthcare organizations worldwide.
Significance of ISO 13485:2016 Certification
The ISO 13485:2016 certification is a globally recognized standard that specifies requirements for a quality management system specific to organizations providing medical device-related services.
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.
The standard focuses on several critical aspects, including risk management, stringent process controls, and maintaining effective processes specifically designed for medical device documentation.
Comprehensive Certification Process
To achieve this certification, Milestone Localization underwent a rigorous evaluation process. The assessment included:
- A detailed review of the company’s quality management system documentation, ensuring alignment with the specific requirements of ISO 13485:2016
- Thorough audit of operational processes related to medical device translation services
- Validating processes to ensure traceability and accountability
- Evaluation of specialized risk management procedures implemented specifically for medical device documentation
- Assessment of the company’s ability to maintain regulatory compliance across multiple international markets
- Verification of specialized training and qualification requirements for linguists working on medical device content
Enhanced Service Offering for Medical Device Manufacturers
Medical documentation requires exceptional precision and regulatory awareness, as errors can impact patient safety.
“Achieving ISO 13485 certification is a significant milestone for us. It reinforces our commitment to quality and our continued focus on supporting medical device clients with accurate, compliant translations they can trust.” — Nikita Agarwal, Founder & CEO, Milestone Localization
About Milestone Localization
Milestone Localization is an ISO 17100, ISO 9001, and now ISO 13485 certified language service provider offering comprehensive translation and localization services across various industries, with specialized expertise in the medical device and healthcare sectors.
With offices in the UK and India and a global network of experienced linguists specialized in medical and technical content, Milestone Localization ensures that medical device manufacturers can effectively communicate with healthcare professionals and patients worldwide while maintaining regulatory compliance.
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