{"id":7000154224,"date":"2025-02-05T09:53:32","date_gmt":"2025-02-05T09:53:32","guid":{"rendered":"https:\/\/www.plastod.com\/?page_id=7000154224"},"modified":"2026-04-30T10:30:30","modified_gmt":"2026-04-30T10:30:30","slug":"certification","status":"publish","type":"page","link":"https:\/\/www.plastod.com\/fr\/certification\/","title":{"rendered":"Certification"},"content":{"rendered":"

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Certifications<\/p>\n

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Conformit\u00e9 des produits<\/h1>\n

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Nous nous engageons \u00e0 offrir des solutions m\u00e9dicales s\u00fbres, fiables et de haute qualit\u00e9 \u00e0 nos clients en Italie et dans le monde.<\/span><\/p>\n

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\u00c9voluant dans un march\u00e9 mondial des dispositifs m\u00e9dicaux en constante mutation, Plastod s\u2019adapte continuellement aux avanc\u00e9es technologiques et aux \u00e9volutions r\u00e9glementaires.<\/h3>\n

Garantir des standards \u00e9lev\u00e9s en mati\u00e8re de qualit\u00e9, de s\u00e9curit\u00e9 et de responsabilit\u00e9 environnementale n\u00e9cessite un mod\u00e8le organisationnel particuli\u00e8rement performant.<\/h3>\n

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Le syst\u00e8me de management de Plastod couvre l\u2019ensemble des phases de conception, de production et de contr\u00f4le qualit\u00e9 des dispositifs m\u00e9dicaux. L\u2019entreprise est certifi\u00e9e par un organisme notifi\u00e9 reconnu \u00e0 l\u2019\u00e9chelle internationale et accr\u00e9dit\u00e9 au niveau europ\u00e9en, conform\u00e9ment aux normes <\/span>ISO 9001<\/b> et <\/span>ISO 13485<\/b>. Par ailleurs, Plastod est soumise \u00e0 des audits r\u00e9guliers r\u00e9alis\u00e9s par les autorit\u00e9s comp\u00e9tentes, tant europ\u00e9ennes qu\u2019extra-europ\u00e9ennes, dans les pays o\u00f9 ses dispositifs sont enregistr\u00e9s.<\/span><\/p>\n

La <\/span>s\u00e9curit\u00e9 des produits<\/b> demeure une priorit\u00e9 strat\u00e9gique. En actualisant en permanence ses comp\u00e9tences techniques, ses connaissances r\u00e9glementaires et ses applications cliniques, Plastod garantit des solutions \u00e0 la pointe en mati\u00e8re de qualit\u00e9 et de fiabilit\u00e9.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Plastod a r\u00e9alis\u00e9 avec succ\u00e8s la transition vers le nouveau r\u00e8glement europ\u00e9en relatif aux dispositifs m\u00e9dicaux (MDR)<\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=\u00a0\u00bb4.27.4″ text_font=\u00a0\u00bbRubik|300|||||||\u00a0\u00bb text_text_color=\u00a0\u00bbgcid-50828945-3c18-4689-ac10-51c91885c7a7″ text_font_size=\u00a0\u00bb16px\u00a0\u00bb text_line_height=\u00a0\u00bb1.4em\u00a0\u00bb locked=\u00a0\u00bboff\u00a0\u00bb global_colors_info=\u00a0\u00bb{%22gcid-50828945-3c18-4689-ac10-51c91885c7a7%22:%91%22text_text_color%22%93}\u00a0\u00bb theme_builder_area=\u00a0\u00bbpost_content\u00a0\u00bb]<\/p>\n

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Les dispositifs m\u00e9dicaux fabriqu\u00e9s par Plastod portent le marquage CE, conform\u00e9ment \u00e0 la r\u00e9glementation en vigueur sur les dispositifs m\u00e9dicaux, avec une certification d\u00e9livr\u00e9e par l\u2019Organisme Notifi\u00e9 Kiwa Cermet Italia.<\/span><\/p>\n

En obtenant la certification MDR bien avant les \u00e9ch\u00e9ances fix\u00e9es par la r\u00e9glementation, Plastod se distingue comme un partenaire fiable capable d\u2019accompagner ses clients dans la transition r\u00e9glementaire tout en garantissant la <\/span>conformit\u00e9 aux exigences les plus r\u00e9centes<\/b>.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Contr\u00f4le syst\u00e9matique des processus<\/h3>\n

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Tous les <\/span>processus de conception et de production<\/b> de Plastod sont r\u00e9alis\u00e9s avec la plus grande rigueur et selon des <\/span>standards de qualit\u00e9 \u00e9lev\u00e9s<\/b>. Les lignes de production et les d\u00e9partements de fabrication sont soumis \u00e0 des protocoles de validation stricts, essentiels pour l\u2019assurance qualit\u00e9 des dispositifs m\u00e9dicaux. Les zones de production sont class\u00e9es salles blanches ISO 8, permettant de contr\u00f4ler les niveaux de contamination particulaire et microbiologique afin de garantir la <\/span>st\u00e9rilit\u00e9 <\/b>et la <\/span>s\u00e9curit\u00e9 <\/b>des produits.<\/span><\/p>\n

Chaque \u00e9tape de la production \u2014 y compris les proc\u00e9d\u00e9s de st\u00e9rilisation par irradiation ou par traitement \u00e0 l\u2019oxyde d\u2019\u00e9thyl\u00e8ne \u2014 est valid\u00e9e et soigneusement surveill\u00e9e. Les fournisseurs de mati\u00e8res premi\u00e8res doivent \u00e9galement respecter des <\/span>standards de qualit\u00e9<\/b> stricts <\/b>afin d\u2019assurer l\u2019excellence du produit final et la s\u00e9curit\u00e9 de l\u2019utilisateur.<\/span><\/p>\n

Plastod garantit le maintien de la qualit\u00e9 gr\u00e2ce \u00e0 un contr\u00f4le rigoureux des mat\u00e9riaux et des produits. Avec des dispositifs m\u00e9dicaux enregistr\u00e9s aux niveaux europ\u00e9en et international, l\u2019entreprise op\u00e8re dans le plein respect des normes de conformit\u00e9, en \u00e9troite collaboration avec les organismes notifi\u00e9s et les autorit\u00e9s r\u00e9glementaires mondiales.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Outils de contr\u00f4le<\/h3>\n

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Afin de garantir la conformit\u00e9 \u00e0 chaque \u00e9tape \u2014 de la conception initiale jusqu\u2019au produit fini \u2014 Plastod dispose d\u2019un <\/span>laboratoire interne structur\u00e9<\/b>, capable de r\u00e9aliser des essais physiques et fonctionnels selon des m\u00e9thodes bas\u00e9es sur des normes techniques reconnues. Le laboratoire est \u00e9quip\u00e9 d\u2019instruments r\u00e9guli\u00e8rement \u00e9talonn\u00e9s afin d\u2019assurer pr\u00e9cision et fiabilit\u00e9.<\/span><\/p>\n

Pour les <\/span>essais complexes<\/b> et les \u00e9tudes exp\u00e9rimentales approfondies, Plastod collabore avec des laboratoires <\/span>externes accr\u00e9dit\u00e9s<\/b>, avec lesquels elle d\u00e9finit les protocoles de test et analyse les r\u00e9sultats.<\/span><\/p>\n

L\u2019entreprise s\u2019appuie \u00e9galement sur des consultants sp\u00e9cialis\u00e9s en applications cliniques pour mener des analyses approfondies du rapport b\u00e9n\u00e9fice-risque de ses dispositifs m\u00e9dicaux.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Expertise sur toutes les classes de risque<\/h3>\n

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Gr\u00e2ce \u00e0 sa connaissance approfondie de la r\u00e9glementation europ\u00e9enne et aux certifications obtenues, Plastod est habilit\u00e9e \u00e0 concevoir et fabriquer des <\/span>dispositifs m\u00e9dicaux<\/b> appartenant \u00e0 <\/span>toutes les classes de risque<\/b>, de la classe I \u00e0 la classe III. La classification des dispositifs repose sur le niveau de risque potentiel pour le patient en cas de dysfonctionnement, principalement d\u00e9termin\u00e9 par le degr\u00e9 d\u2019invasivit\u00e9 du dispositif et la dur\u00e9e de contact avec le corps du patient.<\/span><\/p>\n

Cette expertise \u00e9tendue t\u00e9moigne de la grande flexibilit\u00e9 op\u00e9rationnelle de l\u2019entreprise dans la gestion de dispositifs pr\u00e9sentant diff\u00e9rents niveaux de complexit\u00e9, tout en garantissant s\u00e9curit\u00e9, conformit\u00e9 et fiabilit\u00e9.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Nos certifications<\/h3>\n

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Plastod op\u00e8re conform\u00e9ment \u00e0 des certifications reconnues \u00e0 l\u2019\u00e9chelle internationale, qui garantissent les <\/span>standards les plus \u00e9lev\u00e9s dans la fabrication de dispositifs m\u00e9dicaux<\/b> :<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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CertificationsConformit\u00e9 des produitsNous nous engageons \u00e0 offrir des solutions m\u00e9dicales s\u00fbres, fiables et de haute qualit\u00e9 \u00e0 nos clients en Italie et dans le monde.

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