JIS T 14971 Medical Devices Test Standard for the Application of Risk Management to Medical Devices

EUROLAB laboratory provides testing and compliance services within the scope of JIS T 14971 standard. This standard specifies terminology, principles and a process for the risk management of medical devices, including software as medical devices and in vitro diagnostic medical devices.

The process described in this standard is intended to assist medical device manufacturers in identifying medical device-related hazards, predicting and evaluating associated risks, controlling those risks, and monitoring the effectiveness of controls.

The requirements of this standard apply to all stages of the life cycle of a medical device. The process described in this standard applies to risks associated with a medical device, such as risks related to biocompatibility, data and system security, electrical, moving parts, radiation, and usability.

The process described in this standard can also be applied to products that are not required to be medical devices in some jurisdictions and may be used by others involved in the medical device lifecycle.

This standard requires manufacturers to establish objective criteria for risk acceptability, but does not specify acceptable levels of risk.

Risk management can be an integral part of a quality management system. However, this standard does not require the manufacturer to have a quality management system in place.

EUROLAB assists manufacturers with JIS T 14971 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.