{"id":271039,"date":"2022-02-12T17:22:56","date_gmt":"2022-02-12T16:22:56","guid":{"rendered":"https:\/\/cadtech.es\/non-categorise\/como-osstem-implant-acelera-el-desarrollo-de-implantes-seguros-y-conformes-a-nivel-global\/"},"modified":"2026-02-23T12:32:25","modified_gmt":"2026-02-23T11:32:25","slug":"como-osstem-implant-acelera-el-desarrollo-de-implantes-seguros-y-conformes-a-nivel-global","status":"publish","type":"post","link":"https:\/\/cadtech.es\/fr\/perspectivas\/como-osstem-implant-acelera-el-desarrollo-de-implantes-seguros-y-conformes-a-nivel-global\/","title":{"rendered":"Comment Osstem Implant acc\u00e9l\u00e8re le d\u00e9veloppement d\u2019implants s\u00fbrs et conformes \u00e0 l\u2019\u00e9chelle mondiale"},"content":{"rendered":"

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(Photo \u00a9 Osstem Implant )<\/em><\/h6>\n

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Osstem Implant, l\u2019un des principaux fabricants mondiaux d\u2019implants dentaires, a adopt\u00e9 la plateforme 3DEXPERIENCE de Dassault Syst\u00e8mes et la solution sectorielle License to Cure for Medical Device afin d\u2019acc\u00e9l\u00e9rer la mise sur le march\u00e9 de dispositifs m\u00e9dicaux innovants, s\u00fbrs et pleinement conformes aux r\u00e9glementations internationales. L\u2019objectif: combiner personnalisation, qualit\u00e9 et conformit\u00e9 r\u00e9glementaire sans freiner l\u2019innovation.<\/p>\n

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Innovation pour un sourire sain<\/h2>\n

Fond\u00e9e en 1997, Osstem Implant est leader en Asie-Pacifique dans le secteur des implants dentaires, avec une forte pr\u00e9sence en Cor\u00e9e et en Chine, et se positionne parmi les cinq plus grands fabricants au monde. Sa comp\u00e9titivit\u00e9 repose sur un engagement fort en R&D ainsi que sur des technologies avanc\u00e9es d\u2019usinage de haute pr\u00e9cision, des traitements de surface et des contr\u00f4les qualit\u00e9 rigoureux.<\/p>\n

Le march\u00e9 dentaire exige une grande vari\u00e9t\u00e9 d\u2019implants adapt\u00e9s aux caract\u00e9ristiques sp\u00e9cifiques de chaque patient: implants ultra larges, courts ou piliers personnalis\u00e9s. Pour r\u00e9pondre \u00e0 cette diversit\u00e9, l\u2019entreprise avait besoin d\u2019une infrastructure de gestion de l\u2019information flexible et robuste, capable de s\u2019adapter \u00e0 la demande croissante de personnalisation sans compromettre l\u2019efficacit\u00e9.<\/p>\n

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Conformit\u00e9 r\u00e9glementaire sans freiner le d\u00e9veloppement<\/h2>\n

La croissance mondiale implique de se conformer \u00e0 des r\u00e9glementations nationales et internationales exigeantes. En particulier, la mise en \u0153uvre du syst\u00e8me UDI (Unique Device Identification) conforme \u00e0 la FDA a repr\u00e9sent\u00e9 une \u00e9tape cl\u00e9 pour am\u00e9liorer la tra\u00e7abilit\u00e9 et la s\u00e9curit\u00e9 des patients.<\/p>\n

Cependant, bien qu\u2019Osstem Implant g\u00e9n\u00e8re et transmette d\u00e9j\u00e0 les informations UDI \u00e0 la base de donn\u00e9es GUDID de la FDA, ces donn\u00e9es n\u2019\u00e9taient pas connect\u00e9es aux informations de conception ni aux processus internes de qualit\u00e9. Cela compliquait le suivi en cas d\u2019erreurs et ralentissait la g\u00e9n\u00e9ration de nouveaux identifiants pour sa large gamme de produits.<\/p>\n

L\u2019entreprise avait besoin d\u2019une solution capable d\u2019int\u00e9grer la conception, la qualit\u00e9, la r\u00e9glementation et la production dans un environnement unifi\u00e9.<\/p>\n

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(Photo \u00a9 Osstem Implant)<\/em><\/h6>\n
<\/h5>\n

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3DEXPERIENCE et License to Cure: int\u00e9gration de bout en bout<\/h2>\n

Pour g\u00e9rer globalement les informations UDI, les modifications de conception et les processus qualit\u00e9, Osstem Implant a choisi la plateforme 3DEXPERIENCE<\/a> et la solution License to Cure for Medical Device, d\u00e9velopp\u00e9e sp\u00e9cifiquement pour le secteur des sciences de la vie.<\/p>\n

Cette solution fournit un cadre collaboratif et int\u00e9gr\u00e9 qui relie les donn\u00e9es de d\u00e9veloppement produit aux informations de qualit\u00e9 et de r\u00e9glementation au sein d\u2019une source unique mise \u00e0 jour. Elle prend \u00e9galement en charge les contr\u00f4les de conception r\u00e9gis par les normes ISO et la soumission des informations UDI \u00e0 la FDA via le standard HL7 SPL.<\/p>\n

Apr\u00e8s sa mise en \u0153uvre, des processus auparavant g\u00e9r\u00e9s de mani\u00e8re isol\u00e9e ont \u00e9t\u00e9 enti\u00e8rement int\u00e9gr\u00e9s : gestion de la nomenclature (BOM), device master record (DMR), contr\u00f4le documentaire et gestion des versions, exigences, certifications, substances environnementales et, en particulier, gestion des UDI.<\/p>\n

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Tra\u00e7abilit\u00e9, qualit\u00e9 et r\u00e9activit\u00e9<\/h2>\n

L\u2019int\u00e9gration de l\u2019UDI dans l\u2019environnement 3DEXPERIENCE a consid\u00e9rablement am\u00e9lior\u00e9 le contr\u00f4le qualit\u00e9. Il est d\u00e9sormais possible de retracer rapidement le Device Identifier (DI) et le Production Identifier (PI) en consultant simplement l\u2019UDI du produit.<\/p>\n

Cela permet de r\u00e9agir plus rapidement en cas d\u2019incidents potentiels, d\u2019am\u00e9liorer la s\u00e9curit\u00e9 des patients et de renforcer la surveillance du dispositif sur le march\u00e9. De plus, l\u2019entreprise dispose d\u2019une infrastructure favorisant la collaboration entre les d\u00e9partements qualit\u00e9, production, licences et R&D.<\/p>\n

Gr\u00e2ce \u00e0 la plateforme, Osstem Implant a r\u00e9ussi \u00e0 am\u00e9liorer l\u2019efficacit\u00e9 op\u00e9rationnelle, \u00e0 acc\u00e9l\u00e9rer le time-to-market et \u00e0 renforcer la conformit\u00e9 r\u00e9glementaire, progressant ainsi vers sa vision strat\u00e9gique: devenir le fabricant num\u00e9ro un d\u2019implants dentaires au niveau mondial.<\/p>\n

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<\/div>\n

Article bas\u00e9 sur l\u2019histoire client publi\u00e9e par Dassault Syst\u00e8mes sur son site web officiel.<\/strong>
Acc\u00e9der au cas complet ici: https:\/\/www.3ds.com\/insights\/customer-stories\/osstem-implant<\/a><\/p>\n

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<\/div>\n

\u00c0 propos d\u2019Osstem Implant<\/strong><\/p>\n

Fabricant de dispositifs m\u00e9dicaux dentaires.
Produits: solutions d\u2019implants dentaires, mat\u00e9riaux dentaires et produits pharmaceutiques.
Si\u00e8ge: S\u00e9oul, Cor\u00e9e du Sud.<\/p>\n

Plus d\u2019informations: www.osstem.com<\/a><\/p>\n

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D\u00e9partement Communication de CADTECH<\/strong><\/span><\/p>\n

comunicacion@cadtech.es \u2013 800 007 177<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

(Photo \u00a9 Osstem Implant )Osstem Implant, l\u2019un des principaux fabricants mondiaux d\u2019implants dentaires, a adopt\u00e9 la plateforme 3DEXPERIENCE de Dassault Syst\u00e8mes et la solution sectorielle License to Cure for Medical Device afin d\u2019acc\u00e9l\u00e9rer la mise sur le march\u00e9 de dispositifs m\u00e9dicaux innovants, s\u00fbrs et pleinement conformes aux r\u00e9glementations internationales. L\u2019objectif: combiner personnalisation, qualit\u00e9 et conformit\u00e9 r\u00e9glementaire sans freiner l\u2019innovation.Innovation pour un sourire sain Fond\u00e9e en 1997, Osstem Implant est leader en Asie-Pacifique dans le secteur des implants dentaires, avec une forte pr\u00e9sence en Cor\u00e9e et en Chine, et se positionne parmi les cinq plus grands fabricants au monde. Sa comp\u00e9titivit\u00e9 repose sur un engagement fort en R&D ainsi que sur des technologies avanc\u00e9es d\u2019usinage de haute pr\u00e9cision, des traitements de surface et des contr\u00f4les qualit\u00e9 rigoureux. Le march\u00e9 dentaire exige une grande vari\u00e9t\u00e9 d\u2019implants adapt\u00e9s aux caract\u00e9ristiques sp\u00e9cifiques de chaque patient: implants ultra larges, courts ou piliers personnalis\u00e9s. Pour r\u00e9pondre \u00e0 cette diversit\u00e9, l\u2019entreprise avait besoin d\u2019une infrastructure de gestion de l\u2019information flexible et robuste, capable de s\u2019adapter \u00e0 la demande croissante de personnalisation sans compromettre l\u2019efficacit\u00e9.Conformit\u00e9 r\u00e9glementaire sans freiner le d\u00e9veloppement La croissance mondiale implique de se conformer \u00e0 des r\u00e9glementations nationales et internationales exigeantes. En particulier, la mise […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[212,156],"tags":[],"class_list":["post-271039","post","type-post","status-publish","format-standard","hentry","category-healthcare","category-perspectivas"],"acf":[],"yoast_head":"\nComment Osstem Implant acc\u00e9l\u00e8re le d\u00e9veloppement d\u2019implants s\u00fbrs et conformes \u00e0 l\u2019\u00e9chelle mondiale - Cadtech<\/title>\n<meta name=\"description\" content=\"Osstem Implant acc\u00e9l\u00e8re le d\u00e9veloppement d\u2019implants dentaires s\u00fbrs et personnalis\u00e9s avec 3DEXPERIENCE, en int\u00e9grant la conception, la qualit\u00e9 et la gestion UDI afin de garantir la conformit\u00e9 r\u00e9glementaire mondiale.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cadtech.es\/fr\/perspectivas\/como-osstem-implant-acelera-el-desarrollo-de-implantes-seguros-y-conformes-a-nivel-global\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Comment Osstem Implant acc\u00e9l\u00e8re le d\u00e9veloppement d\u2019implants s\u00fbrs et conformes \u00e0 l\u2019\u00e9chelle mondiale - 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