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UL Medical Business expands services with addition of self test devices for blood coagulation to Notified Body scope

NORTHBROOK, Ill.; June 6, 2007 -- Underwriters Laboratories (UL), a world leader in product safety testing, certification and management system registrations, announced today expansion of its Notified Body scope accreditation with the addition of self test devices for blood coagulation.

Ongoing technological advances have made it possible to design and manufacture sophisticated in vitro diagnostic (IVD) devices for real-time monitoring of blood coagulation that enable even medically untrained users to safely and conveniently obtain reliable results.

Self test coagulation devices are used to monitor the treatment of blood thickness disorders. Users can then determine and implement appropriate changes to dosage levels of medications prescribed to regulate blood thickness. Such devices comprise a new product category known as theranostics - a diagnostic device that functions in combination with a drug dosage system.

"This latest expansion of UL's Notified Body scope accreditation further demonstrates our commitment to providing end-to-end regulatory services for medical device manufacturers and their suppliers," said Anil Patel, General Manager of UL's Medical Business Unit. "UL realizes that such specialized, single-source solutions can help accelerate compliance in the complex global regulatory environment and enable our customers to capitalize on emerging market opportunities."

UL applied for the scope extension in response to a customer request from a major manufacturer in the medical devices sector. Earlier in 2007, UL became the first to offer ISO 14971 Registration Service for medical device manufacturers seeking global regulatory compliance.

To learn more, visit www.ul.com/hitech/medical/index.html. 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.

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