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UL Offers Registration to ISO 14971

Quality Digest
Tue, 03/27/2007 - 22:00
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(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.”

 …

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