Medical Services

Risk Management for Medical Device Industry - ISO 14971 Registration

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UL - First to offer ISO 14971 Registration in 2007

Underwriters Laboratories Inc. (UL) is the first compliance and regulatory service provider to launch an ISO 14971 Registration Service. UL is first to market with this service, supporting our position as an end-to-end regulatory solutions provider and industry leader, with the vision to help the Medical Device industry assess their compliance with the ISO 14971 requirements.

What is 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) continually 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.

Who Needs ISO 14971?

Every regulated medical device manufacturer needs to prove to the regulators that they have practiced risk management for their devices. ISO 14971 is accepted by regulators globally as the standard that addresses this need for risk management.

Benefits of UL's ISO 14971 Registration Service

It is a process oriented approach supporting product certification
Supports flexibility in compliance testing and critical component decisions
Helps suppliers to the medical device industry demonstrate compliance
Helps manufacturers demonstrate due diligence in managing their risks
Assists Medical Device manufacturers in complying with the risk management requirements of ISO 13485:2003 and IEC 60601 3rd Edition