In 2005, Crimson recorded a translation industry first—successfully certifying both its Boston and San Francisco production locations to ISO 9001:2000 and ISO 13485:2003. Crimson is the only translation company in the world to achieve certification to ISO 13485:2003—the quality standard designed specifically for medical device companies and their related services. As stated in our QS Scope, Crimson is certified to provide "Language translation and auxiliary services for the medical technology industries." Crimson's translation quality system was specifically designed by a medical device regulatory consultant and certified by a medical device auditor to satisfy the demanding risk management requirements of medical labeling translation.

Crimson's specialized approach to medical technology translation has been featured in industry publications such as Medical Device & Diagnostics Industry, BI&T Journal (AAMI publication), Orthopedic Design & Technology, and Medical Products Outsourcing.

Thanks to our certified QS and emphasis on risk management, Crimson is the only translation organization in the world registered to ISO 14971:2000. Crimson's proprietary linguistic QA process for translation risk management has received official Notified Body approval and is patent pending (Application Number 60/647670). In fact, KEMA Notified Body has declared that with Crimson's risk management measures in place, you may safely eliminate costly and time-consuming full-document translation review.

At Crimson, we understand that your translated labeling has important risk management and regulatory implications. Our patented processes and certified quality and risk management systems ensure conformance to critical ISO 13485:2003, ISO 14971:2000, MDD, and IVDD labeling requirements. Our professional services structure guarantees that your projects are always supervised by our thoroughly trained staff of experts. Each member of your project team is carefully tested, approved, trained, and audited according to documented, ISO 13485:2003 and ISO 14971:2000 controlled procedures. Most importantly, our roster of satisfied clients provides evidence of Crimson's staff and process effectiveness—delivering you the highest quality/lowest risk translated material.

Please feel free to contact our Boston or San Francisco offices for more information about how Crimson can streamline your labeling translation process and help ensure your regulatory compliance. Please email mmiller@crimsonlanguage.com if you would like a password to access our Resources section (contains valuable regulatory information).