Dr.Localize is proud to announce that it has been officially certified by LL-C Certification for ISO 13485, a globally recognized quality standard for organizations involved in the life cycle of medical devices. The certification covers the scope of “Providing translation services for medical device technical documentation,” reaffirming Dr.Localize’s strong commitment to delivering specialized, high-quality language services, ensuring compliance and accuracy in one of the world’s most regulated industries.

Elevating Quality in the Medical Domain

ISO 13485 sets out stringent requirements for a quality management system where an organization needs to demonstrate its ability to consistently meet regulatory and customer requirements applicable to medical devices and related services. This achievement is a testament to Dr.Localize’s leadership in delivering accurate, compliant, and reliable translations for medical device manufacturers, regulatory affairs teams, and healthcare organizations across the globe.

In a field where terminological precision, regulatory compliance, and linguistic sophistication are critical, Dr.Localize’s ISO 13485 certification further demonstrates its capabilities and trustworthiness.

“This milestone further solidifies our position as a trusted partner in the life sciences sector,” said Mr. Duke Doan, CEO of Dr.Localize. “Being ISO 13485 certified means our processes meet the highest quality standards required by the medical device industry, ensuring every piece of documentation we translate adheres to both linguistic excellence and regulatory compliance.”

A Culture of Quality: ISO 9001, ISO 17100, ISO 18587

This latest achievement builds upon Dr.Localize’s existing foundation of quality, demonstrated by certifications including:

• ISO 9001 – Quality Management System ISO 9001 certifies that Dr.Localize maintains a robust quality management system across all departments and workflows, from project planning and vendor management to client satisfaction and continuous improvement. This standard ensures that every project is delivered with consistency, efficiency, and transparency.

• ISO 17100 – Translation Services Standard This certification confirms that Dr.Localize adheres to strict criteria regarding linguist qualifications, project management, and quality assurance specific to translation services. It guarantees that all translations are executed by qualified professionals, reviewed by experienced editors, and delivered through rigorous quality control processes.

• ISO 18587 – Post-Editing of Machine Translation Output As a forward-looking language service provider, Dr.Localize also holds ISO 18587, the standard for MTPE (Machine Translation Post-Editing). This certification underscores the company’s proficiency in combining cutting-edge technology with human expertise to deliver cost-effective, high-quality translations at scale.

Excelling in the Language Services Industry with Dedication and Excellence

With these certifications, Dr.Localize demonstrates a strong commitment to maintaining best-in-class quality, regulatory compliance, and technological advancement across all sectors it serves—particularly in the medical, technical, legal, and enterprise domains.

Whether translating complex clinical evaluations, user manuals for diagnostic devices, or regulatory submission files, Dr.Localize follows certified processes that meet the highest international standards.