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.
You may also be interested in...
Canada Boosts Postmarket Device Safety With New Reporting Rules
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.
Global Regulators Seek Unified Approach To Remote Inspections
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Canada Proposes 14 New Entries To List Of Recognized Device Standards
The Canadian medtech regulator has recommended updating its list of recognized medical device standards that manufacturers can rely on to demonstrate compliance with local safety, effectiveness and labeling requirements.
Need a specific report? 1000+ reports available
Buy Reports