{"id":697,"date":"2024-06-14T10:06:12","date_gmt":"2024-06-14T10:06:12","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?page_id=697"},"modified":"2026-01-21T09:12:09","modified_gmt":"2026-01-21T09:12:09","slug":"espana-cmc-consulting","status":"publish","type":"page","link":"https:\/\/cmcmedicaldevices.com\/es\/regiones\/espana-cmc-consulting\/","title":{"rendered":"Espa\u00f1a – CMC Consulting"},"content":{"rendered":"
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Espa\u00f1a | CMC CONSULTING<\/h1><\/div>

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Tu partner de servicios de Consultor\u00eda en Espa\u00f1a<\/div>\n<\/div>\n<\/div>\n<\/div><\/h2><\/div><\/div><\/div><\/div><\/div>

Ofrecemos soluciones estrat\u00e9gicas y personalizadas para cumplir con las normativas internacionales y potenciar el \u00e9xito de sus productos en mercados globales.<\/h4><\/div>
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Desde CMC consulting ofrecemos servicios de consultor\u00eda sobre las \u00faltimas normativas, as\u00ed como la preparaci\u00f3n de documentaci\u00f3n t\u00e9cnica.<\/p>\n

CMC le guiar\u00e1 en cada paso de la obtenci\u00f3n del marcado CE para productos sanitarios y de productos de diagn\u00f3stico in vitro bajo los nuevos reglamentos (MDR 2017\/745<\/a><\/u><\/span><\/strong> y IVDR 2017\/746<\/a><\/u><\/span><\/strong>) con el fin de conseguir el marcado CE para su dispositivo. Tambi\u00e9n podemos ayudarte a realizar tus ensayos cl\u00ednicos en la UE para productos sanitarios y dispositivos IVD.<\/p>\n<\/div>

Contacta con nosotros<\/span><\/i><\/i><\/a><\/div><\/div><\/div><\/div><\/div>

Licencia de Importaci\u00f3n de Productos Sanitarios e IVD<\/h3><\/div>
CMC Medical Devices puede asistir a los importadores en la obtenci\u00f3n de una licencia de importaci\u00f3n para productos sanitarios y productos para diagn\u00f3stico in vitro (IVD) en Espa\u00f1a.<\/h6><\/div>

Le guiamos durante el proceso de solicitud, requisitos documentales y cumplimiento de la normativa espa\u00f1ola, asegurando que su sitio de fabricaci\u00f3n cumpla con todos los est\u00e1ndares necesarios.<\/p>\n

Con CMC, podr\u00e1 obtener su licencia de importaci\u00f3n de manera eficiente y cumpliendo totalmente los requisitos del pa\u00eds.<\/p>\n<\/div>

Solicitamos tu licencia de importaci\u00f3n<\/span><\/i><\/i><\/a><\/div><\/div><\/div>

Licencia de Fabricaci\u00f3n de Productos Sanitarios e IVD (AEMPS)<\/h3><\/div>
CMC Medical Devices puede asistir a los fabricantes en la obtenci\u00f3n de una licencia de fabricaci\u00f3n de AEMPS para productos sanitarios y productos para diagn\u00f3stico in vitro (IVD) en Espa\u00f1a.<\/h6><\/div>

Le guiamos durante el proceso de solicitud, requisitos documentales y cumplimiento de la normativa espa\u00f1ola, asegurando que su sitio de fabricaci\u00f3n cumpla con todos los est\u00e1ndares necesarios.<\/p>\n

Con CMC, podr\u00e1 obtener su licencia de fabricaci\u00f3n de manera eficiente y cumpliendo totalmente los requisitos de AEMPS.<\/p>\n<\/div>

Solicitamos tu licencia AEMPS<\/span><\/i><\/i><\/a><\/div><\/div><\/div><\/div><\/div>

EU FSC<\/h3><\/div>
Un Certificado de Libre Venta, a veces denominado \u201cCertificado para la Exportaci\u00f3n\u201d, es una prueba de que los productos sanitarios se venden o distribuyen legalmente en el mercado abierto, libremente y sin restricciones, y est\u00e1n aprobados por las autoridades reguladoras.<\/h6><\/div>

Se utiliza cuando se registra un nuevo producto en un pa\u00eds no europeo. CMC tambi\u00e9n puede solicitar la FSC de la UE para cualquier pa\u00eds del mundo, incluida la legalizaci\u00f3n del pa\u00eds correspondiente.<\/p>\n<\/div>

Solicitamos tu FSC en EUROPA<\/span><\/i><\/i><\/a><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":634,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-697","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nEspa\u00f1a - CMC Consulting | CMC Medical Devices<\/title>\n<meta name=\"description\" content=\"Servicios de consultor\u00eda para dispositivos m\u00e9dicos en Espa\u00f1a. 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