Medical Device Risk Management

This just revised ISO standard promotes the safety of devices and equipment used for medical purposes.  It covers the risks of injury related to the health of patients, the operator and other persons, as well as potential damage to property, equipment and the environment.

ISO 14971, Medical Devices – Application of risk management to medical devices, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products. ISO 14971 helps manufacturers to identify the hazards and estimate the risks associated with a medical device, enabling them to control those risks and monitor the effectiveness of the controls they put in place.  

ISO 14971, Medical Devices – Application of risk management to medical devices can be purchased at the Techstreet Store.

One Response to “Medical Device Risk Management”

  1. The information on this blog is very useful and very interesting. Thanks for sharing.

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