{"id":2464,"date":"2020-04-12T08:05:55","date_gmt":"2020-04-12T05:05:55","guid":{"rendered":"https:\/\/www.eurocert-eqc.com\/?page_id=2464"},"modified":"2023-05-20T03:26:00","modified_gmt":"2023-05-20T00:26:00","slug":"iso-13485-management-for-medical-devices","status":"publish","type":"page","link":"https:\/\/www.eurocert-eqc.com\/en\/certification\/iso-certification\/iso-13485-management-for-medical-devices\/","title":{"rendered":"ISO 13485 Management for Medical Devices"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling fusion-no-small-visibility\" style=\"background-color: #ffffff;background-position: center bottom;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start\" style=\"max-width:calc( 1200px + 0px );margin-left: calc(-0px \/ 2 );margin-right: calc(-0px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_3_5 3_5 fusion-flex-column fusion-animated\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;background-color:#ffffff;border-width: 0 0 0 0;border-color:#efefef;border-style:solid;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-1\" style=\"transform:translate3d(0,0,0);\"><h3 class=\"entry-title fusion-responsive-typography-calculated\" style=\"line-height: 1.15;\" data-fontsize=\"22\" data-lineheight=\"25.3px\">ISO 13485:2016<\/h3>\n<p>Die ISO 13485 ist eine ISO-Norm, die die Erfordernisse f\u00fcr ein umfassendes Qualit\u00e4tsmanagementsystem f\u00fcr das Design und die Herstellung von Medizinprodukten repr\u00e4sentiert.<\/p>\n<p>Die aktuelle Ausgabe ist 2016 ver\u00f6ffentlicht worden und ersetzt direkt die letzte Version aus dem Jahr 2012. In der ISO 13485:2012 wurden fr\u00fchere Normen wie die EN 46001 und EN 46002 (beide aus dem Jahr 1997), die ISO 13485 und ISO 13488 aus dem Jahr 1996 zusammengefasst und erg\u00e4nzt.<\/p>\n<p>Obwohl sie ein eigenst\u00e4ndiges Dokument ist, ist die ISO 13485:2003 in weiten Teilen mit der ISO 9001 identisch. W\u00e4hrend die ISO 9001 die Anforderung stellt, dass die Organisation insgesamt eine kontinuierliche Verbesserung anstreben muss (Qualit\u00e4tsmanagement), bezieht sich der Kernanspruch der ISO 13485 auf die Produktsicherheit und -wirksamkeit. Hier soll die Erf\u00fcllung der Anforderungen an das Produkt durch die Wirksamkeit der eingef\u00fchrten Prozesse sichergestellt werden.<\/p>\n<h3><span style=\"font-size: 22px;\" data-fusion-font=\"true\">Welche Vorteile bietet die ISO 13485 Medizinprodukte?<\/span><\/h3>\n<ul>\n<li>Steigern des Zugangs zu weltweiten M\u00e4rkten durch die Zertifizierung<\/li>\n<li>Beschreiben der Pr\u00fcfungen und Optimieren der Prozesse in Ihrem Unternehmen<\/li>\n<li>Steigern der Effizienz, Senken der Kosten und \u00dcberwachen der Leistung der Lieferkette<\/li>\n<li>Demonstrieren der Herstellung von sichereren und effektiveren Medizinprodukten<\/li>\n<li>Erf\u00fcllen von Medizinprodukterichtlinien (MDD) und Kundenerwartungen<\/li>\n<\/ul>\n<\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-0{width:60% !important;margin-top : 15px;margin-bottom : 15px;}.fusion-builder-column-0 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 0px;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 0px;}@media only screen and (max-width:1000px) {.fusion-body .fusion-builder-column-0{width:100% !important;order : 0;}.fusion-builder-column-0 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-0{width:100% !important;order : 0;}.fusion-builder-column-0 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}<\/style><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_2_5 2_5 fusion-flex-column\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;border-radius:10px 10px 10px 10px;background-color:#ffffff;border-width: 0 0 0 0;border-color:#707070;border-style:solid;border-radius:10px 10px 10px 10px;overflow:hidden;padding: 4% 4% 4% 4%;\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start\" style=\"width:calc( 100% + 0px ) !important;max-width:calc( 100% + 0px ) !important;margin-left: calc(-0px \/ 2 );margin-right: calc(-0px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-0 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\" style=\"background-image: linear-gradient(180deg, var(--awb-custom14) 1%, 90%);background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;border-radius:10px 10px 10px 10px;background-color:rgba(196,196,196,0.27);border-width: 2px 2px 2px 2px;border-color:#707070;border-style:solid;border-radius:10px 10px 10px 10px;overflow:hidden;padding: 4% 4% 4% 4%;\"><div class=\"fusion-text fusion-text-2\" style=\"transform:translate3d(0,0,0);\"><ul>\n<li style=\"list-style-type: none;\"><\/li>\n<\/ul>\n<p><span style=\"color: #ff0000; font-size: 17px;\">&#8220;Unser Ziel war es, unseren Kundenstamm zu vergr\u00f6\u00dfern. Vor allem wird die ISO 13485 die T\u00fcren zur medizinischen Gemeinschaft \u00f6ffnen.&#8221;<\/span><\/p>\n<\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-nested-column-0{width:100% !important;margin-top : 15px;margin-bottom : 15px;}.fusion-builder-nested-column-0 > .fusion-column-wrapper {padding-top : 4% !important;padding-right : 4% !important;margin-right : 0px;padding-bottom : 4% !important;padding-left : 4% !important;margin-left : 0px;}@media only screen and (max-width:1000px) {.fusion-body .fusion-builder-nested-column-0{width:100% !important;order : 0;}.fusion-builder-nested-column-0 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-nested-column-0{width:100% !important;order : 0;}.fusion-builder-nested-column-0 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}<\/style><\/div><div ><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\" style=\"border:1px solid #f0f0f0;border-radius:10px;\"><img decoding=\"async\" src=\"https:\/\/www.eurocert-eqc.com\/wp-content\/uploads\/2020\/04\/meeting-medium.jpg\" class=\"img-responsive\"\/><\/span><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:5px;margin-bottom:5px;width:100%;\"><\/div><div ><span class=\" fusion-imageframe imageframe-none imageframe-2 hover-type-none\" style=\"border:1px solid #f0f0f0;border-radius:10px;\"><img decoding=\"async\" src=\"https:\/\/www.eurocert-eqc.com\/wp-content\/uploads\/2020\/04\/meeting2-medium.jpg\" class=\"img-responsive\"\/><\/span><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:5px;margin-bottom:5px;width:100%;\"><\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-1{width:40% !important;margin-top : 15px;margin-bottom : 15px;}.fusion-builder-column-1 > .fusion-column-wrapper {padding-top : 4% !important;padding-right : 4% !important;margin-right : 0px;padding-bottom : 4% !important;padding-left : 4% !important;margin-left : 0px;}@media only screen and (max-width:1000px) {.fusion-body .fusion-builder-column-1{width:100% !important;order : 0;}.fusion-builder-column-1 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-1{width:100% !important;order : 0;}.fusion-builder-column-1 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}<\/style><\/div><style type=\"text\/css\">.fusion-body .fusion-flex-container.fusion-builder-row-1{ padding-top : 0px;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}<\/style><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling fusion-no-medium-visibility fusion-no-large-visibility\" style=\"background-color: #ffffff;background-position: center bottom;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start\" style=\"max-width:calc( 1200px + 0px );margin-left: calc(-0px \/ 2 );margin-right: calc(-0px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_2_5 2_5 fusion-flex-column\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;border-radius:10px 10px 10px 10px;background-color:#ffffff;border-width: 0 0 0 0;border-color:#707070;border-style:solid;border-radius:10px 10px 10px 10px;overflow:hidden;padding: 4% 4% 4% 4%;\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start\" style=\"width:calc( 100% + 0px ) !important;max-width:calc( 100% + 0px ) !important;margin-left: calc(-0px \/ 2 );margin-right: calc(-0px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-1 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\" style=\"background-image: linear-gradient(180deg, var(--awb-custom14) 1%, 90%);background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;border-radius:10px 10px 10px 10px;background-color:rgba(196,196,196,0.27);border-width: 2px 2px 2px 2px;border-color:#707070;border-style:solid;border-radius:10px 10px 10px 10px;overflow:hidden;padding: 4% 4% 4% 4%;\"><div class=\"fusion-text fusion-text-3\" style=\"transform:translate3d(0,0,0);\"><ul>\n<li style=\"list-style-type: none;\"><\/li>\n<\/ul>\n<p><span style=\"color: #ff0000; font-size: 17px;\">&#8220;Unser Ziel war es, unseren Kundenstamm zu vergr\u00f6\u00dfern. Vor allem wird die ISO 13485 die T\u00fcren zur medizinischen Gemeinschaft \u00f6ffnen.&#8221;<\/span><\/p>\n<\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-nested-column-1{width:100% !important;margin-top : 15px;margin-bottom : 15px;}.fusion-builder-nested-column-1 > .fusion-column-wrapper {padding-top : 4% !important;padding-right : 4% !important;margin-right : 0px;padding-bottom : 4% !important;padding-left : 4% !important;margin-left : 0px;}@media only screen and (max-width:1000px) {.fusion-body .fusion-builder-nested-column-1{width:100% !important;order : 0;}.fusion-builder-nested-column-1 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-nested-column-1{width:100% !important;order : 0;}.fusion-builder-nested-column-1 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}<\/style><\/div><div ><span class=\" fusion-imageframe imageframe-none imageframe-3 hover-type-none\" style=\"border:1px solid #f0f0f0;border-radius:10px;\"><img decoding=\"async\" src=\"https:\/\/www.eurocert-eqc.com\/wp-content\/uploads\/2020\/04\/meeting-medium.jpg\" class=\"img-responsive\"\/><\/span><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:5px;margin-bottom:5px;width:100%;\"><\/div><div ><span class=\" fusion-imageframe imageframe-none imageframe-4 hover-type-none\" style=\"border:1px solid #f0f0f0;border-radius:10px;\"><img decoding=\"async\" src=\"https:\/\/www.eurocert-eqc.com\/wp-content\/uploads\/2020\/04\/meeting2-medium.jpg\" class=\"img-responsive\"\/><\/span><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:5px;margin-bottom:5px;width:100%;\"><\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-2{width:40% !important;margin-top : 15px;margin-bottom : 15px;}.fusion-builder-column-2 > .fusion-column-wrapper {padding-top : 4% !important;padding-right : 4% !important;margin-right : 0px;padding-bottom : 4% !important;padding-left : 4% !important;margin-left : 0px;}@media only screen and (max-width:1000px) {.fusion-body .fusion-builder-column-2{width:100% !important;order : 0;}.fusion-builder-column-2 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-2{width:100% !important;order : 0;}.fusion-builder-column-2 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}<\/style><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_3_5 3_5 fusion-flex-column fusion-animated\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;background-color:#ffffff;border-width: 0 0 0 0;border-color:#efefef;border-style:solid;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-4\" style=\"transform:translate3d(0,0,0);\"><h3 class=\"entry-title fusion-responsive-typography-calculated\" style=\"line-height: 1.15;\" data-fontsize=\"22\" data-lineheight=\"25.3px\">ISO 13485:2016<\/h3>\n<p>Die ISO 13485 ist eine ISO-Norm, die die Erfordernisse f\u00fcr ein umfassendes Qualit\u00e4tsmanagementsystem f\u00fcr das Design und die Herstellung von Medizinprodukten repr\u00e4sentiert.<\/p>\n<p>Die aktuelle Ausgabe ist 2016 ver\u00f6ffentlicht worden und ersetzt direkt die letzte Version aus dem Jahr 2012. In der ISO 13485:2012 wurden fr\u00fchere Normen wie die EN 46001 und EN 46002 (beide aus dem Jahr 1997), die ISO 13485 und ISO 13488 aus dem Jahr 1996 zusammengefasst und erg\u00e4nzt.<\/p>\n<p>Obwohl sie ein eigenst\u00e4ndiges Dokument ist, ist die ISO 13485:2003 in weiten Teilen mit der ISO 9001 identisch. W\u00e4hrend die ISO 9001 die Anforderung stellt, dass die Organisation insgesamt eine kontinuierliche Verbesserung anstreben muss (Qualit\u00e4tsmanagement), bezieht sich der Kernanspruch der ISO 13485 auf die Produktsicherheit und -wirksamkeit. Hier soll die Erf\u00fcllung der Anforderungen an das Produkt durch die Wirksamkeit der eingef\u00fchrten Prozesse sichergestellt werden.<\/p>\n<h3><span style=\"font-size: 22px;\" data-fusion-font=\"true\">Welche Vorteile bietet die ISO 13485 Medizinprodukte?<\/span><\/h3>\n<ul>\n<li>Steigern des Zugangs zu weltweiten M\u00e4rkten durch die Zertifizierung<\/li>\n<li>Beschreiben der Pr\u00fcfungen und Optimieren der Prozesse in Ihrem Unternehmen<\/li>\n<li>Steigern der Effizienz, Senken der Kosten und \u00dcberwachen der Leistung der Lieferkette<\/li>\n<li>Demonstrieren der Herstellung von sichereren und effektiveren Medizinprodukten<\/li>\n<li>Erf\u00fcllen von Medizinprodukterichtlinien (MDD) und Kundenerwartungen<\/li>\n<\/ul>\n<\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-3{width:60% !important;margin-top : 15px;margin-bottom : 15px;}.fusion-builder-column-3 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 0px;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 0px;}@media only screen and (max-width:1000px) {.fusion-body .fusion-builder-column-3{width:100% !important;order : 0;}.fusion-builder-column-3 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-3{width:100% !important;order : 0;}.fusion-builder-column-3 > .fusion-column-wrapper {margin-right : 0px;margin-left : 0px;}}<\/style><\/div><style type=\"text\/css\">.fusion-body .fusion-flex-container.fusion-builder-row-2{ padding-top : 0px;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}<\/style><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":2112,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-2464","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.eurocert-eqc.com\/en\/wp-json\/wp\/v2\/pages\/2464","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.eurocert-eqc.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.eurocert-eqc.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.eurocert-eqc.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eurocert-eqc.com\/en\/wp-json\/wp\/v2\/comments?post=2464"}],"version-history":[{"count":0,"href":"https:\/\/www.eurocert-eqc.com\/en\/wp-json\/wp\/v2\/pages\/2464\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.eurocert-eqc.com\/en\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.eurocert-eqc.com\/en\/wp-json\/wp\/v2\/media?parent=2464"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}