{"id":6840,"date":"2022-02-09T09:42:46","date_gmt":"2022-02-09T09:42:46","guid":{"rendered":"https:\/\/r-biopharm.com\/?p=6840"},"modified":"2022-06-15T10:39:53","modified_gmt":"2022-06-15T10:39:53","slug":"la-prioridad-en-r-biopharm-el-ivdr","status":"publish","type":"post","link":"https:\/\/r-biopharm.com\/es\/la-prioridad-en-r-biopharm-el-ivdr\/","title":{"rendered":"La prioridad en R-Biopharm: el IVDR"},"content":{"rendered":"
[vc_row][vc_column][vc_single_image image=\u00bb6702″ img_size=\u00bbfull\u00bb alignment=\u00bbcenter\u00bb][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=\u00bb.vc_custom_1644583869784{margin-bottom: 0px !important;}\u00bb]La UE ha creado un marco jur\u00eddico para la calidad y la seguridad de los dispositivos m\u00e9dicos in vitro<\/em>, en concreto, el IVDR (Reglamento sobre los productos sanitarios para diagn\u00f3stico in vitro<\/em>), que establece normas m\u00e1s estrictas y jur\u00eddicamente vinculantes para todos los Estados miembros de la UE a partir de mayo de 2022. En primer lugar, este decreto mejora la seguridad cl\u00ednica de los dispositivos m\u00e9dicos de diagn\u00f3stico in vitro<\/em> y establece una base jur\u00eddica uniforme para todos los fabricantes.<\/p>\n

Los elementos clave del nuevo reglamento son requisitos m\u00e1s estrictos de documentaci\u00f3n, pruebas cl\u00ednicas y evaluaci\u00f3n de conformidad, as\u00ed como transparencia y trazabilidad una vez que los productos se lanzan al mercado. Con esta certificaci\u00f3n, los fabricantes demuestran que cumplen con las mas estrictas normas de calidad y seguridad y que cuentan con un sistema de gesti\u00f3n de riesgos eficaz.[\/vc_column_text][vc_single_image image=\u00bb6848″ img_size=\u00bbfull\u00bb alignment=\u00bbcenter\u00bb onclick=\u00bblink_image\u00bb][vc_column_text css=\u00bb.vc_custom_1646733041124{margin-bottom: 0px !important;}\u00bb]Puesto que siempre ha tenido un firme compromiso con la calidad, R-Biopharm afirma su garant\u00eda de cumplimiento al 100\u00a0% de las disposiciones del IVDR y emplea considerables recursos para vigilar la implementaci\u00f3n completa de este reglamento. Nuestro exhaustivo sistema de gesti\u00f3n de la calidad nos permite garantizar el cumplimiento de las normas y los requisitos reglamentarios, as\u00ed como la aplicaci\u00f3n de normas de calidad con la exigencia adecuada para el desarrollo de productos de acuerdo con su uso. De esta manera garantizamos la mejora continua de la calidad con el fin de suministrar productos confiables y de alta calidad a largo plazo para la salud de los consumidores y pacientes.<\/p>\n

R-Biopharm se mantendr\u00e1 firme en su compromiso con la determinaci\u00f3n de responder a los desaf\u00edos futuros, que es uno de los valores esenciales de nuestra empresa. Por supuesto, los periodos de transici\u00f3n se ampliaron; las innovaciones de productos deben cumplir con la nueva normativa a partir del 26 de mayo de 2022, mientras que para los productos existentes de distintas clases, esto solo se aplicar\u00e1 a partir de finales de mayo de 2025 (para productos de clase D), 2026 (clase C) y 2027 (clases A est\u00e9ril y B). A pesar de este hecho, la implementaci\u00f3n de los requisitos de IVDR sigue siendo la prioridad en R-Biopharm.[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

[vc_row][vc_column][vc_single_image image=\u00bb6702″ img_size=\u00bbfull\u00bb alignment=\u00bbcenter\u00bb][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=\u00bb.vc_custom_1644583869784{margin-bottom: 0px !important;}\u00bb]La UE ha creado un marco jur\u00eddico para la calidad y la seguridad de los dispositivos m\u00e9dicos in vitro, en concreto, el IVDR (Reglamento sobre los productos sanitarios para diagn\u00f3stico in vitro), que establece normas m\u00e1s estrictas y jur\u00eddicamente vinculantes para todos los Estados miembros de la UE a […]<\/p>\n","protected":false},"author":1114,"featured_media":6712,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[364],"tags":[],"class_list":["post-6840","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-archivo-de-noticias"],"acf":[],"yoast_head":"\nLa prioridad en R-Biopharm: el IVDR - 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