Industry experts declare that every medical device is defined by a unique combination of product and intended use. The intended use, as stated by the manufacturer, is contained in the product’s labeling and/or instructions for use (IFU). Therefore, medical devices can only be assessed in conjunction with their labeling — in the language of the specific user. This fact, together with regulators’ increasing emphasis on the risk management function of labeling, means that translation accuracy has never been more important.
Crimson Life Sciences is the recognized expert for medical device labeling translation. Since 1992, Crimson has provided the highest quality translated labeling for Class II and Class III device manufacturers. Our innovative approach and exclusive dedication to the medical device industry provides the basis for an array of industry firsts, including:
- First certification to ISO 13485
- First certification to ISO 14971
- Only Notified Body endorsement for translation resource evaluation
- Only Notified Body endorsement for translation risk management
- Only Notified Body endorsement for audit of translated labeling
- Only patent-pending for translation risk management
From resource testing and evaluation, to process design and control, to production software validation, Crimson manages the key elements of translation accuracy, in exact proportion, to produce labeling translations that are 400% more accurate than industry average.
Crimson’s method for labeling translation includes BackEdit™ — our proprietary QC process that lowers the risk of serious translation errors by over 50%. Crimson’s adaptation of the SAE J2450 translation quality standard provides the basis for cost-saving custom processes and is Notified Body endorsed.
To learn more about our unique processes for labeling translation or schedule a live presentation, click here. |
