{"id":271041,"date":"2022-02-12T17:22:56","date_gmt":"2022-02-12T16:22:56","guid":{"rendered":"https:\/\/cadtech.es\/sem-categoria\/como-osstem-implant-acelera-el-desarrollo-de-implantes-seguros-y-conformes-a-nivel-global\/"},"modified":"2026-02-23T11:55:38","modified_gmt":"2026-02-23T10:55:38","slug":"como-osstem-implant-acelera-el-desarrollo-de-implantes-seguros-y-conformes-a-nivel-global","status":"publish","type":"post","link":"https:\/\/cadtech.es\/pt-pt\/perspectivas-pt-pt\/como-osstem-implant-acelera-el-desarrollo-de-implantes-seguros-y-conformes-a-nivel-global\/","title":{"rendered":"Como a Osstem Implant acelera o desenvolvimento de implantes seguros e conformes a n\u00edvel global"},"content":{"rendered":"

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

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A Osstem Implant, um dos principais fabricantes mundiais de implantes dent\u00e1rios, adotou a plataforma 3DEXPERIENCE da Dassault Syst\u00e8mes e a solu\u00e7\u00e3o setorial License to Cure for Medical Device para acelerar a entrega de dispositivos m\u00e9dicos inovadores, seguros e plenamente conformes com as regulamenta\u00e7\u00f5es internacionais. O objetivo: combinar personaliza\u00e7\u00e3o, qualidade e conformidade regulat\u00f3ria sem travar a inova\u00e7\u00e3o.<\/p>\n

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Inova\u00e7\u00e3o para um sorriso saud\u00e1vel<\/h2>\n

Fundada em 1997, a Osstem Implant \u00e9 l\u00edder na \u00c1sia-Pac\u00edfico no setor de implantes dent\u00e1rios, com forte presen\u00e7a na Coreia e na China, posicionando-se entre os cinco maiores fabricantes do mundo. A sua competitividade baseia-se numa aposta decidida na I&D e em tecnologias avan\u00e7adas de maquinagem de ultra precis\u00e3o, tratamentos de superf\u00edcie e rigorosos controlos de qualidade.<\/p>\n

O mercado dent\u00e1rio exige uma ampla variedade de implantes adaptados \u00e0s caracter\u00edsticas espec\u00edficas de cada paciente: implantes ultra largos, curtos ou pilares personalizados. Para responder a esta diversidade, a empresa precisava de uma infraestrutura de gest\u00e3o da informa\u00e7\u00e3o flex\u00edvel e robusta, capaz de se adaptar \u00e0 crescente procura de personaliza\u00e7\u00e3o sem comprometer a efici\u00eancia.<\/p>\n

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Conformidade regulamentar sem travar o desenvolvimento<\/h2>\n

O crescimento global implica cumprir exigentes regulamenta\u00e7\u00f5es nacionais e internacionais. Em particular, a implementa\u00e7\u00e3o do sistema UDI (Unique Device Identification) em conformidade com a FDA representou um passo fundamental para melhorar a rastreabilidade e a seguran\u00e7a do paciente.<\/p>\n

No entanto, embora a Osstem Implant j\u00e1 gerasse e enviasse a informa\u00e7\u00e3o UDI para a base de dados GUDID da FDA, esses dados n\u00e3o estavam ligados \u00e0 informa\u00e7\u00e3o de design nem aos processos internos de qualidade. Isto dificultava o acompanhamento em caso de erros e abrandava a gera\u00e7\u00e3o de novos identificadores para a sua ampla gama de produtos.<\/p>\n

A empresa precisava de uma solu\u00e7\u00e3o capaz de integrar design, qualidade, regulamenta\u00e7\u00e3o e produ\u00e7\u00e3o num ambiente unificado.<\/p>\n

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

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3DEXPERIENCE e License to Cure: integra\u00e7\u00e3o de ponta a ponta<\/h2>\n

Para gerir globalmente a informa\u00e7\u00e3o UDI, as altera\u00e7\u00f5es de design e os processos de qualidade, a Osstem Implant escolheu a plataforma 3DEXPERIENCE<\/a> e a solu\u00e7\u00e3o License to Cure for Medical Device, desenvolvida especificamente para o setor das ci\u00eancias da vida.<\/p>\n

Esta solu\u00e7\u00e3o proporciona um quadro colaborativo e integrado que liga os dados de desenvolvimento de produto \u00e0 informa\u00e7\u00e3o de qualidade e regulamenta\u00e7\u00e3o numa \u00fanica fonte atualizada. Al\u00e9m disso, suporta controlos de design regulados pela ISO e a submiss\u00e3o de informa\u00e7\u00e3o UDI \u00e0 FDA atrav\u00e9s do padr\u00e3o HL7 SPL.<\/p>\n

Ap\u00f3s a sua implementa\u00e7\u00e3o, processos que antes eram geridos de forma isolada passaram a estar completamente integrados: gest\u00e3o da lista de materiais (BOM), device master record (DMR), controlo documental e versionamento, requisitos, certifica\u00e7\u00f5es, subst\u00e2ncias ambientais e, especialmente, a gest\u00e3o de UDI.<\/p>\n

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Rastreabilidade, qualidade e resposta \u00e1gil<\/h2>\n

A integra\u00e7\u00e3o do UDI no ambiente 3DEXPERIENCE melhorou significativamente o controlo de qualidade. Agora \u00e9 poss\u00edvel rastrear rapidamente o Device Identifier (DI) e o Production Identifier (PI) simplesmente consultando o UDI do produto.<\/p>\n

Isto permite responder com maior rapidez a poss\u00edveis incidentes, melhorar a seguran\u00e7a do paciente e refor\u00e7ar a vigil\u00e2ncia do dispositivo no mercado. Al\u00e9m disso, a empresa disp\u00f5e de uma infraestrutura que promove a colabora\u00e7\u00e3o entre os departamentos de qualidade, produ\u00e7\u00e3o, licen\u00e7as e I&D.<\/p>\n

Gra\u00e7as \u00e0 plataforma, a Osstem Implant conseguiu melhorar a efici\u00eancia operacional, acelerar o time-to-market e refor\u00e7ar a conformidade regulamentar, avan\u00e7ando assim para a sua vis\u00e3o estrat\u00e9gica: tornar-se o fabricante n\u00famero um de implantes dent\u00e1rios a n\u00edvel mundial.<\/p>\n

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<\/div>\n

Artigo baseado na hist\u00f3ria de cliente publicada pela Dassault Syst\u00e8mes na sua p\u00e1gina web oficial.<\/strong>
Aceda ao caso completo aqui: https:\/\/www.3ds.com\/insights\/customer-stories\/osstem-implant<\/a><\/p>\n

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<\/div>\n

Sobre a Osstem Implant<\/strong><\/p>\n

Fabricante de dispositivos m\u00e9dicos dent\u00e1rios.
Produtos: solu\u00e7\u00f5es de implantes dent\u00e1rios, materiais dent\u00e1rios e produtos farmac\u00eauticos.
Sede: Seul, Coreia do Sul.<\/p>\n

Mais informa\u00e7\u00f5es: www.osstem.com<\/a><\/p>\n

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Depto. de Comunica\u00e7\u00e3o da CADTECH<\/strong><\/span><\/p>\n

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

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(Photo \u00a9 Osstem Implant )A Osstem Implant, um dos principais fabricantes mundiais de implantes dent\u00e1rios, adotou a plataforma 3DEXPERIENCE da Dassault Syst\u00e8mes e a solu\u00e7\u00e3o setorial License to Cure for Medical Device para acelerar a entrega de dispositivos m\u00e9dicos inovadores, seguros e plenamente conformes com as regulamenta\u00e7\u00f5es internacionais. O objetivo: combinar personaliza\u00e7\u00e3o, qualidade e conformidade regulat\u00f3ria sem travar a inova\u00e7\u00e3o.Inova\u00e7\u00e3o para um sorriso saud\u00e1vel Fundada em 1997, a Osstem Implant \u00e9 l\u00edder na \u00c1sia-Pac\u00edfico no setor de implantes dent\u00e1rios, com forte presen\u00e7a na Coreia e na China, posicionando-se entre os cinco maiores fabricantes do mundo. A sua competitividade baseia-se numa aposta decidida na I&D e em tecnologias avan\u00e7adas de maquinagem de ultra precis\u00e3o, tratamentos de superf\u00edcie e rigorosos controlos de qualidade. O mercado dent\u00e1rio exige uma ampla variedade de implantes adaptados \u00e0s caracter\u00edsticas espec\u00edficas de cada paciente: implantes ultra largos, curtos ou pilares personalizados. Para responder a esta diversidade, a empresa precisava de uma infraestrutura de gest\u00e3o da informa\u00e7\u00e3o flex\u00edvel e robusta, capaz de se adaptar \u00e0 crescente procura de personaliza\u00e7\u00e3o sem comprometer a efici\u00eancia.Conformidade regulamentar sem travar o desenvolvimento O crescimento global implica cumprir exigentes regulamenta\u00e7\u00f5es nacionais e internacionais. Em particular, a implementa\u00e7\u00e3o do sistema UDI (Unique Device Identification) […]<\/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":[213,97],"tags":[],"class_list":["post-271041","post","type-post","status-publish","format-standard","hentry","category-healthcare","category-perspectivas-pt-pt"],"acf":[],"yoast_head":"\nComo a Osstem Implant acelera o desenvolvimento de implantes seguros e conformes a n\u00edvel global - Cadtech<\/title>\n<meta name=\"description\" content=\"A Osstem Implant acelera o desenvolvimento de implantes dent\u00e1rios seguros e personalizados com a 3DEXPERIENCE, integrando design, qualidade e gest\u00e3o UDI para garantir a conformidade regulamentar global.\" \/>\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\/pt-pt\/perspectivas-pt-pt\/como-osstem-implant-acelera-el-desarrollo-de-implantes-seguros-y-conformes-a-nivel-global\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Como a Osstem Implant acelera o desenvolvimento de implantes seguros e conformes a n\u00edvel global - 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