Originally Published MPMN
Originally Published MPMN July 2004
On-Line Service Facilitates Clinical Investigations
(click to go to site).|
An on-line service enables subscribers to access the latest regulatory information for medical devices in European countries. The Regulatory Intelligence Centre (RIC), launched by d-Target (Yverdon-les-Bains, Switzerland), helps clinical and regulatory managers develop the right strategies for their products and conduct clinical investigations in compliance with applicable directives or standards.
The Web site lists the appropriate standards applicable to all classes of devices in terms of quality system or risk assessment. The user can query the RIC to find information about a variety of key issues, such as which competent authorities need to be notified for any intended clinical investigation, which investigational plan requires ethics committee approval, and which documents need to be reviewed as a basis for determining device safety and performance.
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