ISO 14971 Medical Devices - Application of Risk Management to Medical Devices

The ISO 14971 standard has been designed by the International Organization for Standards (ISO) to describe the features and testing methods for applying risk management to medical devices. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 14971 Medical devices - Implementation of risk management on medical devices.

In fact, the basis of this standard is the CSA-14971-07 standard developed by the Canadian Standards Association (CSA) (CAN / CSA-ISO 14971-07 Medical Devices - Application of Risk Management to Medical Devices).

The CSA-14971-07 standard describes the process for a manufacturer to identify hazards associated with medical devices, including in vitro diagnostic medical devices, estimate and evaluate associated risks, control these risks, and monitor the effectiveness of controls. The requirements of this standard apply to all stages of a medical device's life cycle. However, it is not valid for clinical decision making. It does not indicate acceptable levels of risk.

This standard does not require the manufacturer to have a quality management system. However, risk management is considered an integral part of a quality management system.

The requirements in the ISO 14971 standard, an international standard, provide manufacturers with a framework in which experience, insight and judgment are systematically applied to manage risks to the use of medical devices. This standard has been specially designed for companies producing medical devices based on the risk management principles that have developed over the years. This standard is also used as a guide for the development and maintenance of a risk management process for other products that do not need to be medical devices and suppliers and other parties involved in the medical device life cycle.

Within the framework of laboratory testing services, our organization also provides services on the application of ISO 14971 Risk management to medical devices.