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Quality Digest

FDA Compliance

UL Offers Registration to ISO 14971

Published: Tuesday, March 27, 2007 - 22:00

(Underwriters Laboratories Inc.; Northbrook, Illinois) -- Underwriters Laboratories Inc., a world leader in product safety testing, and certification and management system registrations, recently unveiled a service for the medical device industry that streamlines the regulatory compliance assessment process for manufacturers seeking global market access efficiencies.

“UL’s leadership in offering the first ISO 14971 registration service is another example of the continuing commitment UL has in providing end-to-end regulatory services for medical device manufacturers and their suppliers,” says Anil Patel, general manager of UL’s medical business unit. “As part of the overall regulatory process unique to the medical device industry, this registration supports both the manufacturer’s ISO 13485 quality management system and the IEC 60601 third edition compliance requirements.”

The UL ISO 14971 registration service is a continuous assessment of a medical device manufacturer’s risk management process that ensures compliance with the risk management process requirements of ISO 60601, third edition. It also provides confidence that the risk management requirements of regulatory bodies in the United States, Europe, Japan, Canada and Australia are met.

“Medical device manufacturers want specialized, single-source solutions that accelerate their compliance with the complex global regulatory environment,” says Harvey Rudolph, Ph.D., global program manager, medical devices. “As the only provider currently offering an ISO 14971 registration service, UL can satisfy the customer’s needs for conformity assessment to ISO 14971.”

UL professionals have expertise in all aspects of regulatory compliance and have been involved in the development of ISO 14971 since 1996. A staff member in UL’s medical devices business unit is the co-author of the ISO 14971 standard. 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 manufacturers’ understanding of the requirements for conformity with ISO 14971.

For more information, visit www.ul.com/newsroom/newsrel/nr031307.html.


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