Many highly specialized medical devices have been introduced globally in recent years, requiring medical professionals, healthcare providers and patients to comprehend complex instructions in order to operate the devices safely. At the same time, manufacturers, technicians and regulators have come to realize the benefits of medical device labeling and documentation that can be clearly and fully understood in a language and format compatible with users' experience and knowledge.
"Medical device labeling must convey to users critical safety information about the product while taking into account the language of both the user and the device documentation," said Steve McRoberts, Principal Engineer, Medical Regulatory & Proprietary Compliance, UL International (UK) Ltd. "Crimson Life Sciences is to be applauded for attaining this first-ever ISO 14971 Registration for a risk management system capable of mitigating safety issues inherent to translation of medical device literature – an issue of great importance to the global medical community."
The international standard for risk management for medical devices known as ISO 14971 has become an integral element for satisfying regulatory requirements in most major markets. Although ISO 14971 has existed since 2000, this is first time that a third party registration has been issued to that standard. ISO 14971 has been formally recognized by the U.S. Food and Drug Administration (FDA) and by Health Canada; the European Union has adopted it as a harmonized standard; Japan has designated it as a Japanese Industrial Standard; and Australia has made it their "de facto" standard for risk management.
"This ISO 14971 Registration required us to critically examine an emerging customer need from a global perspective and combine that with a sustained development effort to create a unique service for medical device manufacturers," said Marc H. Miller, president of Crimson Life Sciences. "The net result is a risk management system that provides our clients with a fundamentally better service offering and supports enhanced internal performance by acting as a common point of reference."
The practice of maintaining equivalent levels of certification between manufacturer and supplier known as Quality System Parity plays a key role in effective risk management. Published research shows that 55 percent of "non-exempt" suppliers have sought such parity through voluntary certification to ISO 13485, an international standard that facilitates harmonized medical device regulatory requirements for quality management systems. Since effective risk management throughout the supply chain is especially vital to the medical device industry, supplier registration to ISO 14971 is valuable to manufacturers interested in maintaining Quality System Parity.
In preparation for its ISO 14971 Registration assessment, Crimson Life Sciences completed a pre-audit gap analysis in 2006. On-site implementation audits are part of UL's service offering to help customers assess their risk management systems based on ISO 14971. UL also provides private on-site training workshops to assist manufacturer's understanding of the requirements for conformity with ISO 14971.
In March 2007, UL became the first third-party organization to offer ISO 14971 Registration Service as part of its end-to-end regulatory services to streamline global market access efficiencies for medical device manufacturers and their suppliers. UL professionals have expertise in all aspects of regulatory compliance and have been involved in the development of ISO 14971 since 1996.
To learn more, visit www.ul.com/hitech/medical/iso14971. For business inquiries, contact Tara Kambeitz, Global Marketing Manager, Medical Business Unit, 1-877-ULHELPS (1-877-854-3577) ext. 55610 or Tara.L.Kambeitz@us.ul.com.
About UL
Underwriters Laboratories is an independent, not-for-profit product safety certification organization that has been writing Standards for Safety, testing products and involved in conformity assessment for well over a century. UL evaluates more than 19,000 types of products, components, materials and systems annually with 21 billion UL Marks appearing on 71,000 manufacturers' products in the global marketplace each year. UL has also issued nearly 9,000 registrations to management system standards and has performed over 12,000 assessments in 62 countries. UL's worldwide family of companies and network of service providers includes 66 laboratory, testing and certification facilities serving customers with business operations on six continents. Visit: www.ul.com/newsroom.
About Crimson Life Sciences
Crimson Life Sciences, founded in 1992, provides Expertise in Translation and Labeling Risk Management for the Medical Technology Industries and is the only translation organization in the world certified to ISO 9001:2000, ISO 13485:2003 and ISO 14971:2000. Crimson's work has been recognized as MDD compliant by an EU Notified Body and the company has also received official Notified Body recognition for its innovative application of the SAE J2450 translation quality standard. The firm's specialized approach to translation risk management is patent pending.
Crimson's specialized approach to medical technology translation has been featured in industry publications such as Medical Device & Diagnostics Industry and Medical Products Outsourcing. Founder and president Marc H. Miller holds a degree in languages and literature from Harvard University and an MBA from the Scottish Business School in Stirling, Scotland. While working as a Senior Research Fellow with the international strategy consulting firm S.I.A.R., he prepared strategic assessments for EU and U.S. medical technology firms.
Principal architect of Crimson's risk management system is Kai Simonsen, Crimson's VP of Production and Quality Systems. Co-author of the industry's first risk management patent, Simonsen has been responsible for the development and implementation of Crimson's quality systems and production processes since 2002. A native of Flensburg, Germany, he completed his undergraduate studies in English, Education, and Physics, and has held various positions in the translation and localization field since 1997.
In 2005, Crimson joined the TransPerfect family of companies. Clients benefit from Crimson's specialized quality system and risk management methodology combined with the extensive resources and localization talent of TransPerfect and its software localization unit, Translations.com. For more information, visit: www.medical.crimsonlanguage.com.