IEC 60601 (3rd Ed) Spurs Five-Fold Increase in ISO 14971 GAP Analysis and Registration Activity

BOSTON & SAN FRANCISCO, July 15, 2010 – Crimson Life Sciences, a division of TransPerfect and the first ISO 14971-registered company, today announced their recertification to ISO 14971:2007. The three-year anniversary of the first medical device risk management registration coincides with a 500% increase, industry-wide, in ISO 14971 registration activity. This dramatic increase is directly tied to the specific risk management requirements of IEC 60601 (3rd Edition).

Risk Management’s Three-Year Anniversary
In July of 2006, Crimson completed an extensive Gap Analysis with Dr. Harvey Rudolph, Global Program Manager at Underwriters Laboratories, a 25-year FDA veteran (CDRH), and an original author of ISO 14971. In 2008, Crimson became the first company to successfully register to ISO 14971—the de facto risk management standard for the medical device industry. Now, after one full audit cycle, Crimson has successfully re-certified its pioneering risk management system to ISO 14971:2007—a standard of increasing significance for the medical device industry.  

Crimson’s President, Marc H. Miller, explains, “Last year, we published data that demonstrates the business value of a formal risk management system. Now, the third edition of IEC 60601 confirms our original belief that ISO 14971 will become a key regulatory requirement for all industry participants. This is what led us to obtain the industry’s first ISO 14971 registration: a clear understanding that risk management can have a profoundly beneficial impact on the medical device industry.” (Click here to read “The Alchemy of Risk Management.”)

The third edition of IEC 60601 governs all electrical medical devices and, importantly, contains a normative reference to ISO 14971. This IEC standard imposes a risk management requirement on a large segment of the medical device industry which, according to Notified Body estimates, has increased ISO 14971 registration activity by 500% (year-over-year).

Due Diligence for Labeling Translation
Crimson’s ISO 14971:2007 recertification comes at a crucial time for medical device manufacturers. Labeling scrutiny has become more intense and, according to Notified Body auditors, “major non-conformities are being written for insufficient translation procedures.” Crimson is the only translation provider to hold a formal registration to ISO 14971:2007 and their credentials can help manufacturers demonstrate due diligence in their Notified Body audits. Crimson’s system is the basis for the industry’s only patent pending for labeling translation risk management.

However, warns Miller, manufacturers must exercise caution when sourcing ISO 14971-registered suppliers, “Given the interest in risk management, some suppliers are claiming ISO 14971 ‘conformance’ or ‘compliance’ for marketing purposes. Of course, manufacturers should insist on a registered risk management system that is annually audited by a competent registrar, such as UL.”

Kai Simonsen, Crimson’s VP of Production & Quality Systems adds, “Just as important as continued certification of our formal risk management system is an into our Quality System. Since the elements of risk management mesh very well with ISO 13485, our approach has strengthened our quality processes and produced a true risk management culture in the organization.” The first translation provider registered to 13485, Crimson has been continuously certified to 13485 since 2005.

Risk Management Resources at Crimson
Crimson offers a number of resources on its recently re-launched website. For manufacturers interested in implementing their own risk management system, there is a free, 30-minute instructional video from ISO 14971 co-author, Dr. Harvey Rudolph. Other resources include a labeling symbols library and an archive of published articles.

About Crimson Life Sciences
Crimson is a division of TransPerfect Translations International, Inc. and is the only translation practice devoted exclusively to higher-risk medical devices and IVDs. Crimson is the world’s first translation firm registered to ISO 13485 and ISO 9001 and the only translation firm registered to ISO 14971. TransPerfect, registered to ISO 9001 and EN 15038, is the world’s largest privately held language services provider with more than 70 offices worldwide.