Expert: Update Risk Management Systems to ISO 14971:2007

The risk management process, as spelled out in ISO 14971:2007, “will go a long way to prevent” errors in medical device design and manufacture, Barrett Craner, director of quality assurance for Lipid Science, said at a recent FDAnews audioconference.

ISO 14971 is recognized as the international standard for risk management and is useful for device manufacturers who need to conform to both the European Medical Device Directives and the FDA’s Quality System Regulation. While the FDA does not require risk management, it does require risk evaluation and analysis, Craner noted.

ISO 14971:2007 replaces the original risk management standard, ISO 14971:2000, and a 2003 amendment.

Craner said there are few changes to the 2007 version, and they are not that significant. Modifications include six new terms and definitions:

• In vitro diagnostic medical device;
• Life cycle;
• Postproduction;
• Risk estimation;
• Top management; and
• Use error.

There also is a change in Section 4.3 of ISO 14971:2007 emphasizing the potential path of a hazard — from identification of the hazard to development of a hazardous situation and ultimately harm to the patient or user, Craner said. The standard adds a traceability requirement to the risk management report.

The audioconference, “Manage Risk for Medical Devices: ISO 14971:2007 and Beyond,” can be accessed at www.fdanews.com/conference/detail?eventId=1338.