Medical Device Safety Focus

Reducing and managing risks related to medical devices s the objective of a key industry standard, ISO 14971. Detailed guidance to optimize its use has just been updated. 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.

Recently published ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, is a companion document to the globally recognized risk management standard.

Intended for use by manufacturers of medical devices, both ISO 14971 and ISO/TR 24971 are designed to be read and applied together, providing information on how to identify the hazards associated with medical devices, and measure and manage related risks. ISO/TR 24971 Medical Devices can be purchased here at the ANSI Webstore.

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