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 in 2008 Excel Translations decided to make the necessary investment to become ISO 13485:2003-certified, and be an ISO 13485 Certified Medical Translator. We continue to maintain this certification today. The IOS 13485 standard effectively aligning its quality processes with its clients’ in the medical device, diagnostic, hospital supply, and dental supply industries. This ensures that Excel Translations’ medical translation efforts meet international standards.
BSI Management Systems America, Inc., a leading global provider of management systems assessment and certification solutions, 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.
An ISO 13485 Certified Medical Translator
The decision by 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 were operating in an ISO 9001:2008-certified controlled environment. Our intent with ISO 13485 remains: 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.”
Safety is Critical
Due to the nature of medical devices, safety is the principal objective. To achieve this effectively, medical translations must be accurate. 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, Vice President of Production 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 Medical Translator are:
Your quality system and the quality system of your ISO 13485 certified translation services partner will be seamlessly integrated and harmonized.
You will reduce cost and improve risk mitigation during ISO 13485 audits.
You can introduce a shorter qualifying process and significantly reduce your resource allocation for supplier qualification and control.