The Only Translation Quality System Officially Endorsed to ISO 14971:2000

According to ISO 13485:2003, Section 7.1 (Planning of product realization): The organization shall establish documented requirements for risk management throughout product realization [includes labeling and labeling translation]. Records arising from risk management shall be maintained. Note 3 – See ISO 14971 for guidance related to risk management.

Experts agree: ISO 14971:2000 is the applicable risk management standard for medical devices. In all, FDA accepts ISO 14971:2000 as a consensus standard, ISO 13485:2003 quotes it as a recipe for effective risk management, and the Global Harmonization Task Force (GHTF), in a soon-to-be-published guidance document (SG#/N15R8), specifies risk management for every activity that affects your company’s QS.

The purpose of ISO 14971:2000 is to provide a regulatory framework for identification, estimation, evaluation, and reduction of risk. Risk reduction measures specified by the standard include:

1. Design to eliminate hazardous situations
2. Provide safety mechanisms
3. Provide warning mechanisms
4. Control with labeling and training

As your last line of defense for effective risk reduction, labeling demands careful attention. This is especially true of translated labeling where, according to experts at the 2004 RAPS Annual Conference, inaccurate translation can jeopardize your ISO 14971:2000 compliance in overseas markets. The importance of translation accuracy is clear, but how can you be certain that risk management measures are built in to your labeling translation process?.

Crimson is endorsed to ISO 14971:2000 by the well-known and respected Dutch registrar, KEMA (click here to view endorsement letter) – we are the only translation company in the world to hold this important regulatory credential. Since Registrars are generally obliged to recognize each other’s work, you can use our endorsement with TÜV, BSI, UL or any other registrar to demonstrate evidence of conformity with ISO 13485 and ISO 14971 labeling risk management requirements..

Our process incorporates many of the same risk control methods employed by medical technology companies, including process redundancy and diversity. In fact, our risk management methods are so effective, we have a patent pending (Application Number 60/647670)..

Process Redundancy.

Traditional translation risk management relies on a single redundant review – translation and edit. However, this basic process is inadequate for the regulatory requirements of medical translation. Crimson’s patented process has three separate, redundant reviews to ensure labeling quality and compliance:.

Basic Review:

1. Translation/Edit

Redundant Reviews:

1. Linguistic Optimization
2. BackEditing (Linguistic QA)
3. Formatting QA

Process Diversity Along with redundant review, we increase the reliability of our overall process through diversity – each review step controls for a separate risk in the translation process. For instance, our Linguistic Optimization step resolves ambiguities in the source text that can lead to poor translation results, while our BackEditing™ step solves the “native speaker dilemma” and verifies semantic accuracy. Process Approval Crimson has received Notified Body approval and support for several critical risk management activities – together they make up our patented, approved risk management process. According to KEMA’s endorsement letter:

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:

1. Evaluation of prospective translation resources
2. In-process translation QA
3. Audit of existing translated materials

Crimson’s process effectively addresses the two key translation risk-types: Resource Risk and Process Risk. Further, our patented process has received Notified Body approval as a means to eliminate the costly and time-consuming step of Distributor (Third Party/Overseas) Review. Click here and learn more about how our process can save you time and money by eliminating troublesome distributor review.

Visit our Resources section (login password required) for other valuable risk management and regulatory information.