UL Medical Business Unit First to Launch ISO 14971 Registration
Northbrook, Ill., March 13, 2007 -- Underwriters Laboratories Inc. (UL), a world leader in product safety testing and certification and management system registrations, today unveiled a first-of-its-kind service for the medical device industry that streamlines the regulatory compliance assessment process for manufacturers seeking global market access efficiencies.
UL is the first compliance and regulatory service provider to offer a registration service to ISO 14971. As first to market with this service, UL continues to support our position as an end-to-end regulatory solutions provider and industry leader, with the vision to help the Medical Device industry achieve business advantage.
"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," said 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 3rd Edition compliance requirements."
Benefits of UL's ISO 14971 Registration Service:
- Assists Medical Device Manufacturers in complying with the risk management requirements of ISO 13485:2003 and IEC 60601 - Third Edition
- Helps suppliers to the medical device industry demonstrate compliance without multiple vendor audits
- Helps manufacturers demonstrate due diligence in managing their risks
- Supports flexibility in compliance testing and critical component decisions
**Find out how well your Risk Management System complies with ISO 14971.**
View the entire Press Release and download the ISO 14971 Checklist at: www.ul.com/hitech/iso14971
For more information on UL's ISO 14971 Registration Service visit us at www.ul.com/hitech/iso14971 or contact UL's Medical Business Unit at:
Phone: 1-877-854-3577 ext. 49462
Email: Medical@us.ul.com