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Evaluation clinique des dispositifs médicaux

Abstract : Medical devices are health products representing a heterogeneous set of more than 500 000technologies, from the simplest to the most complex ones. Unlike drugs, there is no formalframework for the stages of clinical development of medical devices, especially those with ahigher degree of risk.The objective of this thesis was to describe clinical data available in France when a medicaldevice is launched, and suggest some options to improve the quality and quantity of clinicalstudies performed. To this end, we explored two ways: supporting enterprises for theimplementation of clinical studies that meet the expectations of all stakeholders; and usingregistries to improve the level of available evidence by generating additional post-marketingclinical data.The clinical evaluation of medical devices is complex and difficult, and must go through thelearning of industrials and interactions with health authorities. However, the level of clinicalevidence should and can be improved, including the specialization of methodologists and theaccompaniment of enterprises through platforms close to the clinical field.
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  • HAL Id : tel-00983482, version 1


Laure Huot. Evaluation clinique des dispositifs médicaux. Médecine humaine et pathologie. Université Claude Bernard - Lyon I, 2012. Français. ⟨NNT : 2012LYO10345⟩. ⟨tel-00983482⟩



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