Zenodo (CERN)
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Études de faisabilité précoce en Europe: enjeux, perspectives et impacts attendus pour l'évaluation clinique des dispositifs médicaux (Early feasibility studies in Europe: Challenges, perspectives, and expected impacts on the clinical evaluation of medical devices)
Résumé Le Règlement (UE) 2017/745 sur les dispositifs médicaux (DM) a renforcé l’évaluation clinique et rendu obligatoire la réalisation d’investigations cliniques pour les dispositifs à haut risque. Parmi celles-ci, les &eacu
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