Crimson Language Svc

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Explains Crimson’s President, Marc H. Miller, “By advancing ‘state of the art’ we provide manufacturers with the first real process benchmark for labeling translation which, in turn, helps to satisfy ISO 14971 risk management requirements.

Crimson, the first medical device supplier certified to ISO 13485 and ISO 14971, is the only translation company to be exclusively devoted to the medical device industry. Crimson has been continually serving the labeling and translation needs of medical device manufacturers for nearly 20 years and today client companies represent a broad cross-section of the industry.

Risk management has been a topic of growing importance for manufacturers since an informative reference to ISO 14971 (risk management standard for medical device manufacturers and suppliers) first appeared in ISO 13485:2003. Risk management now touches all aspects of product realization for manufacturers and serves as an important “lingua qualitatis” between manufacturers and suppliers. Most recently, the 3rd edition of IEC 60601 (governs electrical medical devices) contains a normative reference to ISO 14971–firmly enshrining it in the cannon of required device standards.

Over the past two decades, the medical device industry has globalized at a breathtaking pace. In the past ten years alone, manufacturers have more than doubled the number of markets that they routinely address. In the face of multiplying markets and content types, manufacturers now seek suppliers with a global presence. The ability for suppliers to meet, face-to-face, with manufacturers’ overseas staff is vital for good communications–in turn, a key ingredient for effective feedback and translation quality.

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