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Article: Risk management of European device clinical studies.(regulation and standards column)(Clinical report)
- Article from:
- Medical Device Technology
- Article date:
- March 1, 2007
- Author:
CopyrightCOPYRIGHT 2007 Octo Media Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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There is an increasing need to perform clinical studies to support device safety and performance claims. This article discusses risks associated with conducting European clinical studies of medical devices that are unrelated to risks concerning the use of the device. These can jeopardise the success of a clinical study regardless of the safety and performance aspects of the device.
Beyond device risks
The European medical device Directives place significant importance on the need to identify risks related to the use of medical devices and to reduce those risks as much as possible. The Directives require that any risks that may be associated with the use of medical ...