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 13485, 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.
– Dr. Harvey Rudolph, 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, KEMA Notified Body

Notified Bodies will expect to see that manufacturers have a process in place for the translation of medical device labelling…. As translation is a risk related activity (e.g. intent is to minimize the risk of translation inaccuracy), then a recognized management system deemed compliant to ISO 14971 and ISO 13485 should yield maximum assurance of the robustness of the process and the accuracy of translations provided.
– Steve McRoberts, Underwriters Laboratories

We conducted a study in 2007 that demonstrated a 50% failure rate in the risk management function of Class III labeling. Unfortunately, people do not do what you expect, but only what you inspect.
– Dr. Jos Kraus, Dutch Healthcare Inspectorate

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 patent pending.

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