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US AAMI adopts international standard on device clinical trials

This article was originally published in RAJ Devices

Executive Summary

The US Association for the Advancement of Medical Instrumentation has adopted an updated international standard on medical device clinical trials1. The standard, ANSI/AAMI/ISO 14155, has been revised to provide step-by-step guidance on the creation and execution of clinical trials carried out for testing new devices as well as for testing "new indications for use" of an existing device.

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