ISO 14971 -- risk management for medical devices
UL was the first compliance and regulatory service provider to launch an ISO 14971 registration service and continues to support the health sciences industry with knowledge of ISO 14971 and services to support global regulatory submissions.
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.
Are you ready for ISO 14971?
Questions to keep in mind: See how ready you are for IEC 60601 3rd edition. Take UL's self-assessment by clicking the link on our dedicated 3rd edition web page.
- Do you have a policy on determining risk acceptability?
- Do you have links (inputs/outputs) from all your quality management system (QMS) processes to the risk management process?
- Do you include risk management activities in your internal audits?
- Do you review the risk management system/activities when you periodically review your quality management system?
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.
ISO 14971 - The UL advantage
- Prepares medical device manufacturers for the risk management requirements in IEC 60601 3rd edition
- The ISO 14971 process-oriented approach supports product certification
- Offers flexibility in compliance testing and critical component decisions
- Helps component suppliers to the medical device industry demonstrate compliance
- Helps manufacturers demonstrate due diligence in managing their risks
Impartiality statement
UL 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 industry General Manager.
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Additional resources
- On-demand 30 minute online course "Introduction to Risk Management for Medical Devices Pursuant to EN ISO 14971:2009"
- Now for sale - Risk Management Toolbox - Email Medical.Inquiry@ul.com for more information and pricing
- Are you ready for ISO 14971 registration? Download this checklist to find out (registration required)
- Download Siemens Magnet Technology Ltd. ISO 14971 used in IEC 60601 3rd Edition Case Study (registration required)
- UL Knowledge Services supports the industry with training to ISO 14971, visit http://www.uluniversity.com/ for learning options in your region.
