Re: UL issues first ISO 14971 Certificate
The press release: "UL First to Offer ISO 14971 Registration Service for Medical Device Manufacturers Seeking Global Regulatory Compliance
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'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."
The UL ISO 14971 Registration Service is a continuous assessment of a medical device manufacturer's risk management process that assures compliance with the risk management process requirements of ISO 60601 3rd edition. It also provides confidence that the risk management requirements of regulatory bodies in the U.S., 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," said 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 manufacturer's understanding of the requirements for conformity with ISO 14971.
About ISO 14971
As the only international standard for Risk Management for Medical Devices, ISO 14971 has become an integral element for satisfying regulatory requirements in most major markets and should be incorporated into the medical device life cycle.
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.
The purpose of ISO 14971 is to assist medical device manufacturers in establishing, documenting and maintaining a risk management process to: 1) identify hazards and hazardous conditions; 2) estimate and evaluate the associated risks; 3) control those risks; and 4) monitor the effectiveness of the controls put in place throughout the product life cycle.
ISO 14971 is referenced in a number of other important medical device standards, including the third edition of IEC 60601-1(electrical safety), IEC 60601-1-6 (usability), ISO 13485:2003 (quality) and IEC 62304 (software), among others."