A Medical Device Daily Staff Report

Crimson Life Sciences (Boston), a division of TransPerfect (New York) and the only ISO 13485 and ISO 14971 certified translation provider, was recently granted a translation risk management patent (U.S. Patent No. 8,140,322 B2).

Invented by Kai Simonsen, Crimson's VP of Production & Quality Systems, and Marc Miller, Division President, the Crimson patent provides a valuable advancement that device makers can use to demonstrate compliance and satisfy key risk management requirements for translated labeling.

Article 1, Section 8 of the U.S. Constitution grants Congress the power to issue patents. To insure success, an application must be novel, useful, non-obvious, and, by definition, advances "state of the art" in the field in which it is granted. Crimson's process patent for translation risk management defines this new state of the art for medical device labeling translation—with important quality and compliance benefits for medical device manufacturers.

Due to issues of patient safety, risk management is a critical consideration for medical device manufacturers. Since its initial publication over 10 years ago, ISO 14971 has been the device industry's standard for effective risk management. Shortly after publication, ISO 14971 was directly referenced by the industry's other key standard: ISO 13485. And, just recently, ISO 14971 was formally required for device manufacturers through IEC 60601 (3rd Ed)—the standard for electrical devices.

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