{"id":6630,"date":"2015-02-20T20:12:45","date_gmt":"2015-02-20T19:12:45","guid":{"rendered":"https:\/\/digiterm.hu\/qualite-et-securite\/"},"modified":"2024-10-06T21:45:27","modified_gmt":"2024-10-06T19:45:27","slug":"qualite-et-securite","status":"publish","type":"page","link":"https:\/\/digiterm.hu\/fr\/qualite-et-securite\/","title":{"rendered":"Qualit\u00e9 et s\u00e9curit\u00e9"},"content":{"rendered":"

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R\u00c8GLEMENT DE L’UE SUR LES DISPOSITIFS M\u00c9DICAUX<\/h2><\/div>

Le nouveau r\u00e8glement sur les dispositifs m\u00e9dicaux 2017\/745 (MDR)<\/strong> est entr\u00e9 en vigueur dans l’UE le 26 mai 2021. Tous les dispositifs m\u00e9dicaux relevant de la classe I doivent \u00eatre conformes au r\u00e8glement MDR d\u00e8s le premier jour. La plupart de nos chaises appartiennent \u00e0 ce groupe.<\/p>\n

Nous avons le plaisir de vous informer que Digiterm a termin\u00e9 la phase de pr\u00e9paration et est maintenant conforme au MDR.<\/p>\n

ID Acteur\/SRN : HU-MF-000004201<\/strong><\/p>\n

Digiterm sur EDUAMED Liste des op\u00e9rateurs \u00e9conomiques Produits<\/a><\/p>\n

Digterm sur EDUAMED<\/a><\/p>\n<\/div><\/div><\/div>

Suite \u00e0 l’enregistrement, certains changements seront visibles sur les \u00e9tiquettes des chaises. Elles contiennent l’identifiant UDI-DI du type de chaise et la d\u00e9nomination de la chaise dans la langue locale de la destination.<\/p>\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

Si vous avez des questions relatives \u00e0 la gestion de la qualit\u00e9, veuillez contacter notre l’\u00e9quipe QMS & EMS :<\/strong><\/p>\n

E-mail : quality@digiterm.hu<\/a><\/p>\n

Contact <\/i><\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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<\/a>Syst\u00e8me de gestion de la qualit\u00e9<\/h2><\/span>
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Afin d’atteindre nos objectifs, les\u00a0normes ISO 9001:2015<\/strong> pour la qualit\u00e9 des produits et des services et EN ISO 13485:2016<\/strong>, en particulier pour la qualit\u00e9 des produits m\u00e9dicaux, sont maintenues. La conformit\u00e9 aux exigences des normes fait l’objet d’audits r\u00e9guliers.<\/p>\n

ISO 9001:2015 Syst\u00e8me de gestion de la qualit\u00e9
\n<\/strong>Reg. No. : C603179
\nDate d’expiration : 03.09.2026<\/p>\n

Voir le certificat<\/a><\/h3>\n

ISO 13485:2016 Syst\u00e8me de gestion de la qualit\u00e9
\n<\/strong>Reg. No. : 145207
\nDate d’expiration : 06.09.2026<\/p>\n

Voir le certificat<\/a><\/h3>\n<\/div><\/div><\/div>
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Syst\u00e8me de gestion de l’environnement<\/h2><\/span>
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La direction de Digiterm Ltd. a d\u00e9clar\u00e9 son engagement – conform\u00e9ment aux exigences de la norme ISO 14001:2015<\/strong> – en faveur du d\u00e9veloppement continu des performances environnementales et de la pr\u00e9vention de la pollution.<\/p>\n

La conformit\u00e9 aux exigences des normes fait l’objet d’audits r\u00e9guliers.<\/p>\n

ISO 14001:2015 Syst\u00e8me de management environnemental
\n<\/strong>Reg. Non. : 24081586KIR
\n<\/strong>Date d’expiration : 14.09.2027<\/strong><\/p>\n

Voir le certificat<\/a><\/h3>\n<\/div><\/div><\/div>
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Enregistrement et inscription des dispositifs aupr\u00e8s de la FDA<\/span><\/b><\/h2><\/h2><\/span>
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Les produits de Digiterm appartiennent \u00e0 une cat\u00e9gorie g\u00e9n\u00e9rique de dispositifs de classe I exempt\u00e9s, tels que d\u00e9finis dans 21 CFR Parts 862-892, et il n’est donc pas n\u00e9cessaire d’introduire une demande de notification pr\u00e9alable \u00e0 la mise sur le march\u00e9 et d’obtenir l’autorisation de la FDA avant de commercialiser le dispositif aux \u00c9tats-Unis.<\/span><\/p>\n

Toutefois, en tant que fabricant, Digiterm doit enregistrer son \u00e9tablissement :<\/span><\/p>\n

L’enregistrement de l’\u00e9tablissement de Digiterm aupr\u00e8s de la FDA est disponible ici.<\/span><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div>

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<\/a>Certificat SFDA<\/h2><\/h2><\/span>
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\"\"<\/p>\n<\/td>\n

Digiterm Ltd., en tant que fabricant de dispositifs m\u00e9dicaux, est \u00e9galement enregistr\u00e9 par l’Autorit\u00e9 saoudienne des aliments et des m\u00e9dicaments<\/strong>. (L’autorisation permet de commercialiser les fauteuils de confort dans le Royaume d’Arabie Saoudite.<\/p>\n

Le certificat est d\u00e9livr\u00e9 conform\u00e9ment au Medical devices interim regulation (MDIR) et en particulier au implementing rule MDS-IR6 for Medical Device Marketing Authorisation (MDMA).<\/p>\n

Num\u00e9ro d’autorisation :<\/strong>MDMA-1-2018-1153
\nDate d’<\/strong> expiration<\/strong>: 26.02.2027.<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div>

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<\/a>Certificat GOST-R<\/h2><\/h2><\/span>
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\"\"<\/p>\n<\/td>\n

Digiterm Ltd., fabricant de dispositifs m\u00e9dicaux, est \u00e9galement enregistr\u00e9 par le minist\u00e8re russe de la sant\u00e9. (Num\u00e9ro d’enregistrement : F33 2012\/11522)<\/p>\n

Les fauteuils Comfort Therapy sont test\u00e9s par SGS International Certification Services S. A.<\/strong> et le certificat GOST-R atteste de leur conformit\u00e9 aux normes russes en vigueur.<\/p>\n

Num\u00e9ro de certificat POCC HU. IM 24 N Q5939<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div><\/div><\/main>

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DO YOU HAVE QUESTIONS ABOUT OUR PRODUCTS?<\/h2><\/span>
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We work as a united team around the world and give our clients the highest quality products and solutions possible. Our sales team will be happy to help you!<\/h3>\n<\/div>
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Nous contacter<\/span><\/a><\/div><\/div><\/div><\/div><\/div>\n<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"100-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6630","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nQualit\u00e9 et s\u00e9curit\u00e9 - Digiterm Ltd.<\/title>\n<meta name=\"description\" content=\"Digiterm Dialysis chairs are designed to provide a comfortable and supportive seating arrangement for patients.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/digiterm.hu\/fr\/qualite-et-securite\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qualit\u00e9 et s\u00e9curit\u00e9 - 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