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