Regulatory – Clinical Methodologies for Medical Device Clinical Trials

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SKU: 978-90-804771-8-6 Category:


Thesis for the fulfilment of the requirements for the Degree of Doctor in Social Health Sciences at the University of Ghent. Chapter 1 gives an overview of the medical device regulatory requirements and the basic principles of compliance.In Chapter 2 the GCP environment as it applies to medical devices and related ethical issues for conducting medical device trials is discussed. In Chapter 3 the various trial methodologies available and how they can or cannot be applied to medical devices is examined. In Chapter 4 the clinical trial method and outcome of a Class I medical device trial are discussed. Chapter 5 concludes with an overview of future regulatory and ethical developments.

English, 179 pages
August 2008
ISBN: 978-90-804771-8-6


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