ISO 14971:2019 (medical devices)

The standard ISO 14971:2019 Medical devices — Application of risk management to medical devices has recently been issued.

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.

The 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. The standard was updated to better align with changes in medical device regulations around the world.

For details, see: https://www.iso.org/obp/ui/#iso:std:iso:14971:ed-3:v1:en

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)