Medical devices – Application of risk management to medical devices, ISO 14971:2007, is the definitive worldwide Standard for the medical device sector. It is a management Standard, covering the entire life cycle of all types of medical devices. It helps manufacturers and other users to ensure the safety and effectiveness of medical devices used in healthcare facilities worldwide.

Within the Standard is a defined risk management process. Since no medical device can be completely safe, there is a need for risk management to support manufacturers, clinicians, regulatory authorities, and the public in making decisions about the health and safety of specific products.

The Standard builds on well-established risk management principles and on the work of other risk frameworks, and provides a recognised process for manufacturers of medical devices. All the key principles of risk management apply – the Standard provides a management system and specifies that the steps of hazard identification, risk estimation, risk evaluation, risk control, and risk review must be included in any manufacturer's risk management process.

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.

Summarised from an article by Alfred Dolan, Convenor of ISO/IEC working group 1, and Stan Mastrangelo, working group 1 member, in ISO Focus magazine, June 2009.