Underwriters Laboratories

Medical Devices

Choose A Subject of Interest:

Advanced Search

Home > Industries > Health Sciences > Medical Devices > ISO 14971 -- Risk Management for Medical Devices

ISO 14971 -- risk management for medical devices

UL was the first compliance and regulatory service provider to launch an ISO 14971 registration service. As an end-to-end regulatory solutions provider and industry leader, UL led with the vision to help the medical device industry assess their compliance with the ISO 14971 requirements.

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.

Regulatory acceptance

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.

The UL advantage

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

Impartiality statement

Underwriters Laboratories places the utmost importance on the integrity and impartiality of its management system certification activities and the trust it conveys to its clients, their customers and the public at large. The principles inspiring this confidence include impartiality, competence, responsibility, openness, confidentiality, and responsiveness to complaints. These principles are identifiable in UL's Mission Statement. If any internal or external person or body should ever have concern of a situation that may threaten impartiality, it should immediately be brought to the attention of the UL Health Sciences General Manager.

Feedback regarding UL subscribers and UL services

At UL our goal is to continually improve our service to our customers and the customers of UL Subscribers. Should you have any feedback, please contact us and we will respond accordingly.

Additional resources