Bien qu’il ajoute une administration suppl\u00e9mentaire des dispositifs m\u00e9dicaux pr\u00e9sents sur le march\u00e9, le nouveau syst\u00e8me offre une garantie suppl\u00e9mentaire \u00e0 l’utilisateur final que le dispositif enregistr\u00e9 utilis\u00e9 est s\u00fbr, qu’il est conforme aux r\u00e9glementations les plus strictes et qu’en cas d’\u00e9v\u00e9nements inattendus, il sera plus facile de prendre des mesures correctives et pr\u00e9ventives afin d’\u00e9viter que des \u00e9v\u00e9nements similaires ne se reproduisent. Digiterm s’y conforme encore aujourd’hui, mais apr\u00e8s la fin du mois de mai, il se conformera \u00e9galement \u00e0 ce r\u00e8glement.<\/p>
\n
\n
Nos fauteuils th\u00e9rapeutiques appartiennent \u00e0 la classe I du point de vue des risques. Nos fauteuils avec mesure de poids int\u00e9gr\u00e9e Comfort-3 Scale et Comfort-4 Scale sont des exceptions, car ils appartiennent au groupe de risque de classe I m. Pour ces produits, la nouvelle r\u00e9glementation ne sera appliqu\u00e9e qu’apr\u00e8s 2025, \u00e9tant donn\u00e9 qu’il s’agit d’appareils anciens et que leur conformit\u00e9 est r\u00e9guli\u00e8rement contr\u00f4l\u00e9e par des organisations tierces.<\/p>
\n
\n
Le r\u00e8glement devait \u00eatre introduit en mai 2020, mais en raison de la pand\u00e9mie de Covid-19, il a \u00e9t\u00e9 report\u00e9 d’un an. \u00c0 partir du25<\/sup> mai 2021, tout nouveau dispositif m\u00e9dical fabriqu\u00e9 et utilis\u00e9 devra \u00eatre conforme au RIM.<\/p>
\n
\nNous avons le plaisir de vous informer que Digiterm a termin\u00e9 la phase de pr\u00e9paration et est maintenant conforme au MDR.<\/p>
\n
\n
Identifiant de l’acteur\/SRN : HU-MF-000004201<\/strong><\/p>
\n
\nMaintenant que le module d’enregistrement d’EUDAMED est disponible, nous avons demand\u00e9 et re\u00e7u les identifiants UDI-DI pour nos types de produits.<\/p>
\n
\n
\u00c0 la suite de l’enregistrement, certains changements seront \u00e9galement visibles sur les \u00e9tiquettes des chaises. Elles contiennent l’identifiant UDI-DI du type de chaise ainsi que la d\u00e9nomination de la chaise dans la langue locale de la destination.<\/p>
\n
\n
Tout en fournissant des solutions de si\u00e8ges s\u00fbres et de haute qualit\u00e9 dans le monde entier, la satisfaction de nos partenaires a toujours \u00e9t\u00e9 et restera une valeur cl\u00e9 pour nous.<\/p>
\n
\n
Si vous avez des questions relatives \u00e0 la gestion de la qualit\u00e9, veuillez contacter notre \u00e9quipe QMS & EMS :<\/p>
\n
\n
Courriel : quality@digiterm.hu<\/a><\/p>
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