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La mise sur le marché de l’Union européenne de tout dispositif médical (DM) nécessite de faire la démonstration de sa conformité aux exigences essentielles (de sécurité et de performance) déterminées par les directives européennes. Selon la classe (niveau de dangerosité du DM), une série de tests devront être conduits en respectant les normes harmonisées correspondantes. Un audit par un organisme...
Set the date range to filter the displayed results. You can set a starting date, ending date or both. You can enter the dates manually or choose them from the calendar.