Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5547018 | Annales Pharmaceutiques Françaises | 2016 | 9 Pages |
Abstract
The amount and level of evidence of clinical studies is naturally correlated to admittance of SMD. These findings suggest that the clinical evidence used to demonstrate safety and efficacy for high-risk medical devices is based on clinical studies with poor quality data, making more difficult the evaluation of SMD in hospital. The development of a multi-criteria tool to help decision-making would improve the process of SMD evaluation by the CODIMS.
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Authors
A. Boudard, A.-L. Cordonnier, N. Martelli, P. Lechat, M. Sinègre, J. Pineau,