Translated Labeling an Important Risk Management Issue The growing influence of risk management for medical device manufacturers is evident in a number of important ways (read more). Now, statements from industry experts and regulatory authorities highlight the risk management importance of another critical service: translation of labeling and product information (read Risk Management Statements).

Commendations Based on Audited Risk Management System
In order to satisfy your labeling risk management requirements, Crimson has developed the world’s first translation risk management system specifically for medical device manufacturers. Registered to ISO 14971:2000 by Underwriters Laboratories (read more), Crimson’s risk management system is patent pending and recommended by industry experts:

"…Crimson’s efforts to improve and perfect the translation of labeling should be an integral part of any [manufacturer’s] risk management system."
—Dr. Harvey Rudolph, co-author of ISO 14971

"Crimson Life Sciences is to be applauded for attaining this first-ever ISO 14971 certification for a risk management system capable of mitigating safety issues inherent to translation of medical device literature – an issue of great importance to the medical community."
—Steve McRoberts, Principal Engineer, Medical Regulatory & Proprietary Compliance, UL

"Identifying and preventing serious errors is the key translation risk management consideration (a serious error is one that may result in patient harm). In this regard, your adaptation and use of the SAE translation quality metric (SAE J2450) is supported by KEMA for the following purposes…

• Evaluation of prospective translation resources
• In-process translation QA
• Audit of existing translated materials"

—KEMA Notified Body

In fact, with Crimson’s risk management processes in place, you can eliminate the burdensome requirements of full-document distributor review (read more). For companies wishing to maintain a review process, Crimson offers the only Notified Body-endorsed method for translation audit (read more). We provide custom audit/review services for some of the best-known names in the medical device industry.