Are Your Medical Translations at Risk? The advantages of working with an ISO 13485-certified medical translator.

Translation for medical device manufacturers is increasingly perceived by regulators and Notified Bodies as a key outsourcing activity. Issues related to outsourcing and supplier control are at the core of the ISO 13485 standard. This is the reason why Excel Translations has decided to make the necessary investment to become ISO 13485:2003-certified, effectively aligning its quality processes with its clients' in the medical device, diagnostic, hospital supply, and dental supply industries. BSI Management Systems America, Inc., a leading global provider of management systems assessment and certification solutions, has awarded Excel Translations the ISO 13485 certification for its translation services. ISO 13485:2003 demonstrates the existence of an effective quality system that satisfies the rigors of an independent, external audit and addresses the additional safety, regulatory, and quality concerns specific to the medical device industry.

The decision of Excel Translations - already certified to global quality standard ISO 9001 since 2000 - to pursue certification to ISO 13485:2003 is explained by president Hervé Rodriguez: "For eight years we have been operating in an ISO 9001:2008-certified controlled environment. Our intent with ISO 13485 is to better align ourselves with the medical device industry and to provide additional reassurance to our clients and prospects that, indeed, their projects are in good hands with us. We are proud to offer our clients both certifications in order to seamlessly integrate with their quality processes."

Due to the nature of medical devices, safety is the principal objective. Whereas ISO 9001:2000 seeks continuous improvement, the intent of ISO 13485:2003 is to get it right from the beginning. "ISO 13485 is an unforgiving, black-and-white standard," says Rob de Cortie, Manager of Quality Assurance at Excel Translations. "It does not allow for companies to have poor quality or an ineffective process that they can improve upon. Instead, it demands an effective system resulting in a high-quality product from the get-go. We want to assure medical device manufacturers that the same safety, regulatory compliance and care that they apply in order to design and manufacture the best possible device goes into translating the literature that accompanies medical devices."

Benefits of working with an ISO 13485-Certified Translation Partner are:

QMS HARMONIZATION
Your quality system and the quality system of your ISO 13485-certified translation partner will be seamlessly integrated and harmonized.

AUDITS
You will reduce cost and improve risk mitigation during ISO 13485 audits.

VENDOR QUALIFICATION
You can introduce a shorter qualifying process and significantly reduce your resource allocation for supplier qualification and control.

Excel Translations' quality assurance processes enable the company to meet and exceed the strict regulatory requirements and quality standards of its clients. The company's certification to and compliance with ISO 9001:2008, ISO 13485:2003, ISO 14971:2007, EN 15038, and ASTM F 2575-06 acknowledge its long-standing commitment to excellence and its unwavering efforts to provide unparalleled quality to its customers. Contact us for more information about our medical translation services.