Historical
ANSI/AAMI/ISO TIR24971:2013
Medical devices - Guidance on the application of ISO 14971
Experience indicates that manufacturers have difficulty with practical implementation of some clauses of the risk management International Standard, ISO 14971:2007, Medical devices - Application of risk management to medical devices. This Technical Report provides guidance to assist in the development, implementation and maintenance of risk management for medical devices that aim to meet the requirements of ISO 14971. It provides guidance for specific aspects of ISO 14971 for a wide variety of medical devices. These medical devices include active, non-active, implantable, and non-implantable medical devices and in vitro diagnostic medical devices
Content Provider
Association for the Advancement of Medical Instrumentation [aami]
