World’s First Translation Risk Management Patent Advances “State of the Art”; Helps Manufacturers Satisfy ISO 14971 Risk Management Requirements
Bio Portfolio - April 18, 2012
BOSTON & SAN FRANCISCO – (Business Wire) – Crimson Life Sciences, a division of TransPerfect and the only ISO 13485 and ISO 14971 certified translation provider, was recently granted the world’s first 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 H. Miller, Division President, the Crimson patent provides a valuable advancement to “state of the art” that device makers can use to demonstrate compliance and satisfy key risk management requirements for translated labeling.
Advancing “State of the Art” for Medical Device Translation
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.
ISO 14971 and “State of the Art”
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.
Among the most important requirements described in ISO 14971 is management responsibility (section 3.2), including the requirement to reference “state of the art” when determining risk acceptance:
Top management shall provide evidence of its commitment to the risk management process by… determining criteria for risk acceptability; this policy shall…take into account available information such as the generally accepted state of the art…
Indeed, the risk management significance of “state of the art” is specifically cited no fewer than 12 times throughout ISO 14971.
Steve McRoberts, Global Principal Engineer – Medical Regulatory Programs at Underwriters Laboratories (UL), provides a regulatory perspective: “In terms of ISO 14971, ‘state of the art’ applies to expectations of the risk/benefit, rather than ‘cutting edge’. By seeking to reduce patient safety errors, the Crimson patent certainly advances ‘state of the art’ in this regard.”
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. The patent documentation itself makes a solid addition to any manufacturer’s Risk Management File.”
Labeling and labeling translation are areas of growing concern for device makers—both in terms of cost and quality. In fact, research indicates that labeling errors are the number one cause of costly recalls. And accuracy in translated labeling is a matter of increased legal attention in Europe and other worldwide markets.
Compliance and Risk Management Benefits for Manufacturers
Appendix D.8.4 of ISO 14971 instructs manufacturers to reduce their risks to the “lowest level practicable, bearing in mind the state of the art and the benefits of accepting the risk.” This is especially important for device labeling, which is itself a risk control. According to Dr. Harvey Rudolph (an original author of ISO 14971):
Generating accurate translations for native language users helps to assure that devices are operated safely. This is especially true for those portions of the labeling that are themselves risk controls…Thus, Crimson must play a role in their clients’ risk management process, and their efforts to improve and perfect the translation of labeling should be an integral part of any client’s risk management system.
By advancing “state of the art,” Crimson’s patented process clearly helps manufacturers satisfy key risk management requirements, providing unmatched compliance and peace of mind.
About Crimson Life Sciences
Crimson Life Sciences is a division of TransPerfect Translations International, Inc. and is the only translation practice exclusively devoted to the medical device industry. Crimson is the world’s first translation firm certified to both ISO 13485 and ISO 9001 and the only translation firm certified to ISO 14971. Crimson’s ISO 14971-certified risk management system is the basis for the world’s only translation risk management patent (U. S. Patent No. 8,140,322 B2). TransPerfect, certified to ISO 9001 and EN 15038, is the world’s largest privately held language services provider with more than 75 offices worldwide. For more information, visit www.crimsonlanguage.com.