Translation Risk Management

Safety and effectiveness are guiding principles for the medical device industry. In response, risk management practices have extended their reach from product design and development right through to post-market information. Now, with the widespread adoption of ISO 14971 and IEC 60601, risk management touches every aspect of manufacturers’ operations — including labeling and labeling translation:

Generating accurate translations for native language users helps to assure that medical devices are operated safely. This is especially true for those portions of the labeling that are themselves risk controls established by the manufacturer (information for safety). Also, there is no doubt that failures of labeling translation comprise post market information that the original device manufacturer needs to assess as part of its risk management process. 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.
Dr. Harvey Rudolph, 25-year FDA veteran, co-author of ISO 14971

Because product labeling fulfills an important risk management function, Notified Bodies and Competent Authorities recognize the importance of labeling translation and control of translation processes:

Due to compliance implications for the essential requirements of the MDD and the IVDD, Notified Bodies consider translation to be an ‘important outsourced service’…. This makes translation providers subject to the outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14971.
Dr. Jeff Schakenraad, DEKRA Notified Body

Fortunately, when it comes to expertise for effective translation risk management, there is a resource you can trust. Crimson Life Sciences is the first translation organization to successfully register to ISO 9001, ISO 13485, and ISO 14971, as well as the only translation firm to receive an official Notified Body endorsement for labeling translation risk management and labeling translation audit. In fact, Crimson’s risk management methods are so effective, they are patented!

In March, 2012, Crimson was granted U.S. Patent No. 8,140,322 for managing risk in medical device translation.  By definition, the Crimson patent advances “state of the art” for medical device translation and helps manufacturers satisfy important risk management requirements (read more).

Specifically, labeling and labeling translation are areas of growing concern for device makers—both in terms of cost and quality. In fact, research shows 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. With Crimson’s patented process you can enjoy labeling compliance and regulatory peace of mind.   

To learn more about our unique processes for labeling translation or schedule a live presentation, click here.




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