Risk Management for Medical Devices

The second edition of ISO 14971:2007, Application of Risk Management to Medical Devices, has been released. The revised version aligns better with ISO 13485:2003 requirements and provides an improved model for implementing a risk management system.

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

You can purchase the standard for $160 at this web page at the ANSI site.

ISO/TR 14969:2004 provides guidance for applying the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. However, its guidance can be used to better understand the ISO 13485 requirements and to illustrate some of the methods and approaches available for meeting those requirements.