{"id":3140,"date":"2022-10-25T11:48:21","date_gmt":"2022-10-25T09:48:21","guid":{"rendered":"https:\/\/scc-medical-devices.com\/risk-assessment\/"},"modified":"2025-06-18T12:04:57","modified_gmt":"2025-06-18T10:04:57","slug":"risikoanalyse-medizinprodukte-din-en-iso-14971","status":"publish","type":"page","link":"https:\/\/scc-medical-devices.com\/de\/risikoanalyse-medizinprodukte-din-en-iso-14971\/","title":{"rendered":"Risk Assessment DE"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3140\" class=\"elementor elementor-3140\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-12dfc16d elementor-section-height-min-height elementor-section-content-middle elementor-section-full_width elementor-section-height-default elementor-section-items-middle\" data-id=\"12dfc16d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-31f99f8d\" data-id=\"31f99f8d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-7bcc5c0f elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile\" data-id=\"7bcc5c0f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-4b99724f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4b99724f\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-49577853\" data-id=\"49577853\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-46a62bcd\" data-id=\"46a62bcd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-60fd62bd animated-slow elementor-invisible elementor-widget elementor-widget-image\" data-id=\"60fd62bd\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_mouse&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInDown&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"#start\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"218\" height=\"206\" src=\"https:\/\/scc-medical-devices.com\/wp-content\/uploads\/start.png\" class=\"attachment-medium size-medium wp-image-2928\" alt=\"\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-73a10efe\" data-id=\"73a10efe\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-3806613 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3806613\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e125d00\" data-id=\"e125d00\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1717dd8e elementor-widget elementor-widget-heading\" data-id=\"1717dd8e\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"start\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Risikomanagement \u2013 EN ISO 14971<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-128715e5 elementor-widget elementor-widget-text-editor\" data-id=\"128715e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Die Anforderungen der EN ISO 14971 sind komplex und bei einer Risikoanalyse k\u00f6nnen viele Fragestellungen auftreten.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-5c845d00 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5c845d00\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-77930f0f\" data-id=\"77930f0f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6d6c10ba elementor-widget elementor-widget-text-editor\" data-id=\"6d6c10ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Bei Medizinprodukten sind die Sicherheit und Wirksamkeit abh\u00e4ngig von der Natur des Produktes und der vorgesehenen Verwendung individuell zu bewerten. Aus diesem Grund ist eine alleinige Betrachtung der grundlegenden Anforderungen zur Auslegung und Herstellung von Medizinprodukten nicht ausreichend. Daher wird es von den Herstellern verlangt, ein<strong>\u00a0Risikomanagementsystem<\/strong>\u00a0einzurichten, anzuwenden, zu dokumentieren und aufrecht zu erhalten. Dabei kommt es darauf an, dass etwaige Risiken bei der Anwendung \u2013 gemessen am Nutzen f\u00fcr den Patienten \u2013 vertretbar und mit einem hohen Ma\u00df an Gesundheitsschutz und Sicherheit vereinbar sein m\u00fcssen, wobei der allgemein anerkannte Stand der Technik zugrunde zu legen ist. Weiterhin ist es erforderlich, potentielle Risiken so weit wie m\u00f6glich zu reduzieren, ohne dass sich dies auf das Nutzen-Risiko-Verh\u00e4ltnis negativ auswirkt.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7491b610 elementor-widget elementor-widget-heading\" data-id=\"7491b610\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Unsere Dienstleistungen im \u00dcberblick<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cc30104 elementor-widget elementor-widget-text-editor\" data-id=\"cc30104\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul>\n<li>Erstellung von Verfahrensanweisungen f\u00fcr die Umsetzung der Risikopolitik und Aktivit\u00e4ten des Risikomanagements<\/li>\n<li>Bereitstellung von Formbl\u00e4ttern f\u00fcr die Risikomanagementakte gem\u00e4\u00df der neuesten ISO 14971 und ISO\/TR 24971, einschlie\u00dflich kundenspezifischer Unterst\u00fctzung<\/li>\n<li>Moderation von Sitzungen des Risikobewertungsteams<\/li>\n<li>Unterst\u00fctzung bei konkreten Fragen und Abweichungen<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-01f99d3\" data-id=\"01f99d3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-inner-section elementor-element elementor-element-3b141e33 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3b141e33\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-5152df65\" data-id=\"5152df65\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1035a7c5 elementor-widget elementor-widget-image\" data-id=\"1035a7c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"570\" src=\"https:\/\/scc-medical-devices.com\/wp-content\/uploads\/Theis-MD-2.jpg\" class=\"attachment-large size-large wp-image-3044\" alt=\"\" srcset=\"https:\/\/scc-medical-devices.com\/wp-content\/uploads\/Theis-MD-2.jpg 1000w, https:\/\/scc-medical-devices.com\/wp-content\/uploads\/Theis-MD-2-421x300.jpg 421w, https:\/\/scc-medical-devices.com\/wp-content\/uploads\/Theis-MD-2-768x548.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-240cfcc1 elementor-widget elementor-widget-text-editor\" data-id=\"240cfcc1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5><strong><span class=\"ap-hl\">IHR ANSPRECHPARTNER<br \/><\/span><\/strong><\/h5><p><strong>Dr. Alexander Theis<\/strong> <br \/>Senior Managing Consultant<br \/>Technical Documentation and Regulatory Affairs, Medical Devices<\/p><p>Tel.: +49 170 4173178<br \/><a href=\"mailto:alexander.theis@ramboll.com\">alexander.theis@ramboll.com<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-7b41ed49 elementor-section-full_width raute-left-row elementor-section-height-default elementor-section-height-default\" data-id=\"7b41ed49\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-45174b75\" data-id=\"45174b75\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-11ee810b elementor-widget elementor-widget-image\" data-id=\"11ee810b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"266\" height=\"602\" src=\"https:\/\/scc-medical-devices.com\/wp-content\/uploads\/Raute-01.png\" class=\"attachment-large size-large wp-image-2929\" alt=\"\" srcset=\"https:\/\/scc-medical-devices.com\/wp-content\/uploads\/Raute-01.png 266w, https:\/\/scc-medical-devices.com\/wp-content\/uploads\/Raute-01-133x300.png 133w\" sizes=\"(max-width: 266px) 100vw, 266px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-7a472ec3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7a472ec3\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6a122301\" data-id=\"6a122301\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5f832974 elementor-widget elementor-widget-heading\" data-id=\"5f832974\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Wir unterst\u00fctzen Sie bei der Einrichtung des Risikomanagements<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3ab1f11e elementor-widget elementor-widget-text-editor\" data-id=\"3ab1f11e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Kontaktieren Sie unsere Experten, wenn Sie zu Beginn der Entwicklung oder vor dem Start der Vermarktung Fragen zu einer Risikoanalyse haben oder sich \u00fcber deren Aktualisierung informieren m\u00f6chten.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4f0e6457 elementor-align-left elementor-widget elementor-widget-button\" data-id=\"4f0e6457\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md elementor-animation-grow\" href=\"https:\/\/scc-medical-devices.com\/de\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 122.88 85.57\"><title>mail<\/title><path d=\"M3.8,0,62.48,47.85,118.65,0ZM0,80.52,41.8,38.61,0,4.53v76ZM46.41,42.37,3.31,85.57h115.9L78,42.37,64.44,53.94h0a3,3,0,0,1-3.78.05L46.41,42.37Zm36.12-3.84,40.35,42.33V4.16L82.53,38.53Z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ihr Kontakt zu Experten<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-1c6aa3f2\" data-id=\"1c6aa3f2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-105557b elementor-widget elementor-widget-template\" data-id=\"105557b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"section\" data-elementor-id=\"4994\" class=\"elementor elementor-4994 elementor-2246 elementor-2246\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-inner-section elementor-element elementor-element-53b1d9f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"53b1d9f\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-711a20e9\" data-id=\"711a20e9\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6ff0af6f elementor-widget elementor-widget-image\" data-id=\"6ff0af6f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/wp-content\/uploads\/Ramboll-SCC_Flyer_MD_General_DE.pdf\" target=\"_blank\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"727\" src=\"https:\/\/scc-medical-devices.com\/wp-content\/uploads\/module-flyer-medical_devices-1.jpg\" class=\"attachment-large size-large wp-image-11170\" alt=\"\" srcset=\"https:\/\/scc-medical-devices.com\/wp-content\/uploads\/module-flyer-medical_devices-1.jpg 500w, https:\/\/scc-medical-devices.com\/wp-content\/uploads\/module-flyer-medical_devices-1-206x300.jpg 206w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-4f1e255\" data-id=\"4f1e255\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5bb0394c elementor-widget elementor-widget-text-editor\" data-id=\"5bb0394c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Unsere Dienstleistungen im \u00dcberblick<br \/><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5298d2f2 elementor-align-right elementor-widget elementor-widget-button\" data-id=\"5298d2f2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-grow\" href=\"\/wp-content\/uploads\/Ramboll-SCC_Flyer_MD_General_DE.pdf\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-caret-square-down\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-541a9f63 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"541a9f63\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-aae2a34\" data-id=\"aae2a34\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7944af7 elementor-widget elementor-widget-heading\" data-id=\"7944af7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Anwendung von Risikomanagement auf Medizinprodukte<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-917cc3b elementor-widget elementor-widget-text-editor\" data-id=\"917cc3b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Die Vorgehensweise bei Risikoanalysen wird durch die\u00a0<strong>EN<\/strong>\u00a0<strong>ISO 14971<\/strong> festgelegt, wobei das Risikomanagement als ein kontinuierlicher, sich wiederholender Prozess w\u00e4hrend des gesamten Lebenszyklus eines Produktes zu verstehen ist, und damit regelm\u00e4\u00dfig systematisch aktualisiert werden muss. Die Anforderungen der EN ISO 14971 sind relativ komplex und h\u00e4ufig kommen formale Fragestellungen auf, w\u00e4hrend eine Risikoanalyse von medizinischen und technischen Experten durchgef\u00fchrt wird.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-179e7563 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"179e7563\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-10a8d4c6\" data-id=\"10a8d4c6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-41486c2a elementor-widget elementor-widget-heading\" data-id=\"41486c2a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Einrichtung des Risikomanagements und Moderation <br>\nUnser Angebot \u2013 Ihre Vorteile<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-122b30bb elementor-widget elementor-widget-text-editor\" data-id=\"122b30bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>SCC bietet Ihnen an, das Risikomanagement entsprechend der Anforderungen der DIN EN ISO 14971 in Ihrem Qualit\u00e4tsmanagementsystem zu etablieren und auch Risikoanalysen zu moderieren. Mit unserer Expertise werden Sie:<\/p>\n<ul>\n<li>Ein Verfahren etablieren, welches alle Anforderungen erf\u00fcllt und auch auf eine breite internationale Akzeptanz st\u00f6\u00dft.<\/li>\n<li>Die Effizienz steigern und mit unserer professionellen Moderation wertvolle Zeit des hochqualifizierten Teams bei der Risikoanalyse einsparen.<\/li>\n<li>Viele Informationen erhalten, die Ihnen dabei helfen, Ihre Medizinprodukte so zu entwickeln, dass diese exakt die Anforderungen der Benutzer und Patienten erf\u00fcllen.<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-7b45a0fc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7b45a0fc\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-64704119\" data-id=\"64704119\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1043a591 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"1043a591\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-xl elementor-animation-grow\" href=\"https:\/\/scc-medical-devices.com\/de\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 122.88 85.57\"><title>mail<\/title><path d=\"M3.8,0,62.48,47.85,118.65,0ZM0,80.52,41.8,38.61,0,4.53v76ZM46.41,42.37,3.31,85.57h115.9L78,42.37,64.44,53.94h0a3,3,0,0,1-3.78.05L46.41,42.37Zm36.12-3.84,40.35,42.33V4.16L82.53,38.53Z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Kontaktieren Sie unsere Experten<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Risikomanagement \u2013 EN ISO 14971 Die Anforderungen der EN ISO 14971 sind komplex und bei einer Risikoanalyse k\u00f6nnen viele Fragestellungen auftreten. Bei Medizinprodukten sind die Sicherheit und Wirksamkeit abh\u00e4ngig von der Natur des Produktes und der vorgesehenen Verwendung individuell zu bewerten. Aus diesem Grund ist eine alleinige Betrachtung der grundlegenden Anforderungen zur Auslegung und Herstellung [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3140","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/pages\/3140","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/comments?post=3140"}],"version-history":[{"count":127,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/pages\/3140\/revisions"}],"predecessor-version":[{"id":10677,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/pages\/3140\/revisions\/10677"}],"wp:attachment":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/media?parent=3140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}