{"id":2380,"date":"2021-01-28T11:55:20","date_gmt":"2021-01-28T10:55:20","guid":{"rendered":"https:\/\/www.yoo.me\/?p=2380"},"modified":"2025-01-29T15:44:53","modified_gmt":"2025-01-29T14:44:53","slug":"legal-manufacturer","status":"publish","type":"post","link":"https:\/\/www.yoo.me\/en\/services-en\/legal-manufacturer\/","title":{"rendered":"Legal Manufacturer"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-center fusion-flex-content-wrap\" 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_1_1 1_1 fusion-flex-column fusion-animated\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:80px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0px;--awb-margin-bottom-medium:70px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0px;--awb-margin-bottom-small:50px;--awb-spacing-left-small:0px;\" data-animationType=\"fadeIn\" data-animationDuration=\"1.0\" data-animationOffset=\"top-into-view\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:var(--awb-typography2-font-size);--awb-line-height:var(--awb-typography2-line-height);--awb-letter-spacing:var(--awb-typography2-letter-spacing);--awb-text-transform:var(--awb-typography2-text-transform);--awb-margin-bottom:10px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p><a href=\"https:\/\/www.bayoocare.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">BAYOOCARE<\/a><\/p>\n<\/div><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-one\" style=\"--awb-margin-bottom:30px;--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:30px;--awb-margin-left-small:0px;--awb-font-size:50px;\"><h1 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"font-family:var(--awb-typography1-font-family);font-weight:var(--awb-typography1-font-weight);font-style:var(--awb-typography1-font-style);margin:0;letter-spacing:-1px;font-size:1em;--fontSize:50;line-height:var(--awb-typography1-line-height);\">Your legal manufacturer for medical devices<\/h1><\/div><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-center fusion-flex-justify-content-center fusion-flex-content-wrap\" style=\"--awb-flex-grow:0;--awb-flex-grow-medium:0;--awb-flex-grow-small:0;--awb-flex-shrink:0;--awb-flex-shrink-medium:0;--awb-flex-shrink-small:0;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_2_3 2_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:66.666666666667%;--awb-margin-top-large:0px;--awb-spacing-right-large:calc( 0.06 * calc( 100% - 0px ) );--awb-spacing-left-large:0px;--awb-width-medium:66.666666666667%;--awb-order-medium:0;--awb-spacing-right-medium:calc( 0.06 * calc( 100% - 0px ) );--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0px;--awb-spacing-left-small:0px;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2 sm-text-align-center\"><p>If you want to launch a medical device internationally, you need very detailed knowledge about the regulatory approval.<br \/>\nWith our experts from BAYOOCARE, we at YOOme help you understand and fulfill the requirements of the target markets.<br \/>\nWe accompany you in successfully launching your medical device on the market.  <\/p>\n<p>We are certified according to ISO 13485:2016 and MDSAP by T\u00dcV S\u00fcd, as a notified and certification body.<br \/>\nIn addition, we have EU-VO 2017\/745 certificates for a risk class IIb and a IIa product (NeoDoppler and Companion Med App).<br \/>\nAs a legal manufacturer, authorized representative or consultant, we are at your side as a partner in over 30 countries &#8211; in Europe, Switzerland, Great Britain and soon also <span style=\"color: var(--awb-text-color);font-family: var(--awb-text-font-family);font-size: var(--awb-font-size);font-style: var(--awb-text-font-style);font-weight: var(--awb-text-font-weight);letter-spacing: var(--awb-letter-spacing);text-align: var(--awb-content-alignment);text-transform: var(--awb-text-transform);background-color: var(--awb-bg-color-hover)\">in the USA.<\/span><\/p>\n<\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--awb-margin-top:25px;\" target=\"_self\" href=\"https:\/\/www.yoo.me\/en\/kontakt\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Contact us now<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-1 fusion_builder_column_inner_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-spacing-left-large:0px;--awb-width-medium:33.333333333333%;--awb-order-medium:0;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0px;--awb-spacing-left-small:0px;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1440\" height=\"385\" alt=\"YOOme BAYOOCARE Legalhersteller MDSAP und T\u00dcV S\u00fcd zertifiziert\" title=\"YOOme BAYOOCARE Legalhersteller MDSAP und T\u00dcV S\u00fcd zertifiziert\" src=\"https:\/\/www.yoo.me\/wp-content\/uploads\/2023\/05\/YOOme-BAYOOCARE-Legalhersteller-MDSAP-und-TUeV-Sued-zertifiziert.png\" data-orig-src=\"https:\/\/yoo.me\/wp-content\/uploads\/2023\/05\/YOOme-BAYOOCARE-Legalhersteller-MDSAP-und-TUeV-Sued-zertifiziert.png\" class=\"lazyload img-responsive wp-image-1877\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271440%27%20height%3D%27385%27%20viewBox%3D%270%200%201440%20385%27%3E%3Crect%20width%3D%271440%27%20height%3D%27385%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/www.yoo.me\/wp-content\/uploads\/2023\/05\/YOOme-BAYOOCARE-Legalhersteller-MDSAP-und-TUeV-Sued-zertifiziert-200x53.png 200w, https:\/\/www.yoo.me\/wp-content\/uploads\/2023\/05\/YOOme-BAYOOCARE-Legalhersteller-MDSAP-und-TUeV-Sued-zertifiziert-400x107.png 400w, https:\/\/www.yoo.me\/wp-content\/uploads\/2023\/05\/YOOme-BAYOOCARE-Legalhersteller-MDSAP-und-TUeV-Sued-zertifiziert-600x160.png 600w, https:\/\/www.yoo.me\/wp-content\/uploads\/2023\/05\/YOOme-BAYOOCARE-Legalhersteller-MDSAP-und-TUeV-Sued-zertifiziert-800x214.png 800w, https:\/\/www.yoo.me\/wp-content\/uploads\/2023\/05\/YOOme-BAYOOCARE-Legalhersteller-MDSAP-und-TUeV-Sued-zertifiziert-1200x321.png 1200w, https:\/\/www.yoo.me\/wp-content\/uploads\/2023\/05\/YOOme-BAYOOCARE-Legalhersteller-MDSAP-und-TUeV-Sued-zertifiziert.png 1440w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 640px) 100vw, 600px\" \/><\/span><\/div><\/div><\/div><\/div><ul style=\"--awb-margin-top:50px;--awb-line-height:27.2px;--awb-icon-width:27.2px;--awb-icon-height:27.2px;--awb-icon-margin:11.2px;--awb-content-margin:38.4px;--awb-circlecolor:var(--awb-color6);--awb-circle-yes-font-size:14.08px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default fusion-no-medium-visibility fusion-no-large-visibility type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-briefcase fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Does it seem impossible to comply with all the legal requirements of your medical device?<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-rocket fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Are you looking for support to identify the launch strategy to market approval for your medical device?<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-gavel fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>You want to be insured in case of damage? As a legal manufacturer, we will take over the liability for your medical device and take care of vigilance or pharmacovigilance.<\/p>\n<\/div><\/li><\/ul><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:74px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-order-small:0;--awb-margin-top-small:50px;--awb-spacing-right-small:0px;--awb-spacing-left-small:0px;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-bottom:30px;--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:30px;--awb-margin-left-small:0px;--awb-font-size:40px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"font-family:var(--awb-typography1-font-family);font-weight:var(--awb-typography1-font-weight);font-style:var(--awb-typography1-font-style);margin:0;letter-spacing:-1px;font-size:1em;--fontSize:40;line-height:var(--awb-typography1-line-height);\">An overview of all services for your medical device<\/h2><\/div><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-center fusion-flex-justify-content-center fusion-flex-content-wrap\" style=\"--awb-flex-grow:0;--awb-flex-grow-medium:0;--awb-flex-grow-small:0;--awb-flex-shrink:0;--awb-flex-shrink-medium:0;--awb-flex-shrink-small:0;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-2 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-1 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-3\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>Legal Manufacturer as a Service<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-3 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-2 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-4\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>Regulatory &amp; legal consulting<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-4 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-3 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-5\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>Liability &amp; legal liability<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-5 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-4 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-6\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>Conformity<br \/> assessment<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-6 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-5 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-7\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>Launch &amp; Market Strategy<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-7 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-6 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-8\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>Clinical Evaluation<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-8 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-7 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-9\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>EU-, CH &amp; UK-Rep<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-9 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-8 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-10\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>Registration of your medical products<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-10 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-9 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-11\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>Opening up new markets<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-11 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-spacing-left-large:10px;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-10 fb-icon-element fontawesome-icon fa-check-circle fas circle-no\" style=\"--awb-font-size:27px;--awb-align-self:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;\"><\/i><div class=\"fusion-text fusion-text-12\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);--awb-margin-top:10px;--awb-margin-right:15px;--awb-margin-left:15px;--awb-text-font-family:var(--awb-typography2-font-family);--awb-text-font-weight:var(--awb-typography2-font-weight);--awb-text-font-style:var(--awb-typography2-font-style);\"><p>Post-Market-Surveillance (PMS)<\/p>\n<\/div><\/div><\/div><\/div><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-center fusion-flex-justify-content-center fusion-flex-content-wrap\" style=\"--awb-flex-grow:0;--awb-flex-grow-medium:0;--awb-flex-grow-small:0;--awb-flex-shrink:0;--awb-flex-shrink-medium:0;--awb-flex-shrink-small:0;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-12 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0px;--awb-spacing-left-small:0px;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-2 fusion-button-default-span fusion-button-default-type fusion-has-button-gradient\" style=\"--awb-margin-top:40px;--button_accent_color:var(--awb-color1);--button_accent_hover_color:var(--awb-color1);--button_border_hover_color:var(--awb-color1);--button_gradient_end:0%;--button_gradient_top_color:var(--awb-color5);--button_gradient_bottom_color:var(--awb-color4);--button_gradient_top_color_hover:hsla(var(--awb-color5-h),calc(var(--awb-color5-s) - 5%),calc(var(--awb-color5-l) - 10%),var(--awb-color5-a));--button_gradient_bottom_color_hover:hsla(var(--awb-color5-h),calc(var(--awb-color5-s) - 5%),calc(var(--awb-color5-l) - 10%),var(--awb-color5-a));\" target=\"_self\" href=\"https:\/\/www.yoo.me\/en\/services\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">More services<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0px;--awb-spacing-left-small:0px;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-bottom:30px;--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:30px;--awb-margin-left-small:0px;--awb-font-size:40px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"font-family:var(--awb-typography1-font-family);font-weight:var(--awb-typography1-font-weight);font-style:var(--awb-typography1-font-style);margin:0;letter-spacing:-1px;font-size:1em;--fontSize:40;line-height:var(--awb-typography1-line-height);\">Our services for your success<\/h2><\/div><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:30px;--awb-margin-left-small:0px;--awb-font-size:20px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:var(--awb-typography2-font-family);font-weight:var(--awb-typography2-font-weight);font-style:var(--awb-typography2-font-style);margin:0;letter-spacing:-1px;font-size:1em;--fontSize:20;--minFontSize:20;line-height:var(--awb-typography1-line-height);\">We create your medical device compliance<\/h3><\/div><div class=\"fusion-text fusion-text-13\"><p>Simply leave regulatory issues relating to your medical device to us.<br \/>\nWhether regulatory affairs, quality and data protection requirements or other compliance issues: we keep an eye on everything for you.<br \/>\nWith Legal Manufacturer as a Service, we offer you as a legal manufacturer an all-round service for your medical device &#8211; so that you successfully pass the conformity assessment procedure.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-5 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:30px;--awb-margin-left-small:0px;--awb-font-size:20px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:var(--awb-typography2-font-family);font-weight:var(--awb-typography2-font-weight);font-style:var(--awb-typography2-font-style);margin:0;letter-spacing:-1px;font-size:1em;--fontSize:20;--minFontSize:20;line-height:var(--awb-typography1-line-height);\">We accompany you during the successful market launch of your medical device<\/h3><\/div><div class=\"fusion-text fusion-text-14\"><p>EU Rep, CH Rep, UK Rep &#8211; Wherever you are planning the approval of your medical device or in-vitro diagnostics, we will create a concept for you as part of our launch strategy, including trend analyses and product classification.<br \/>\ntrend analyses and classification of the product classification.<br \/>\nAt YOOme, our BAYOOCARE experts leave nothing to chance &#8211; for the successful launch and marketing of your medical device.  <\/p>\n<\/div><div class=\"fusion-title title fusion-title-6 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:30px;--awb-margin-left-small:0px;--awb-font-size:20px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:var(--awb-typography2-font-family);font-weight:var(--awb-typography2-font-weight);font-style:var(--awb-typography2-font-style);margin:0;letter-spacing:-1px;font-size:1em;--fontSize:20;--minFontSize:20;line-height:var(--awb-typography1-line-height);\">In the case of damage, we are liable, not you<\/h3><\/div><div class=\"fusion-text fusion-text-15\"><p>Your product safety is our top priority.<br \/>\nIf liability issues do arise, you can rely on us completely.<br \/>\nAs a legal manufacturer, we assume liability for your medical device and take care of vigilance or pharmacovigilance.  <\/p>\n<\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-3 fusion-button-default-span fusion-button-default-type\" style=\"--awb-margin-top:25px;\" target=\"_self\" href=\"https:\/\/www.yoo.me\/en\/kontakt\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Contact us now<\/span><\/a><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>CH-, UK-, EU-Rep, Regulatory Consulting, Post-Market-Surveillance<\/p>\n","protected":false},"author":1,"featured_media":1924,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[103],"tags":[136,126,127,137,134,135,106],"class_list":["post-2380","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-services-en","tag-compliance-en","tag-in-vitro-diagnostics","tag-iso-13485-en","tag-launch-strategy-en","tag-legal-manufacturer","tag-market-launch","tag-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast 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content=\"https:\/\/www.yoo.me\/en\/services-en\/legal-manufacturer\/\" \/>\n<meta property=\"og:site_name\" content=\"YOOme\" \/>\n<meta property=\"article:published_time\" content=\"2021-01-28T10:55:20+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-29T14:44:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.yoo.me\/wp-content\/uploads\/2023\/05\/YOOme-ist-Ihr-Legalhersteller-fuer-Medizinprodukte.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"yoome_wp_admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"yoome_wp_admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"21 minutes\" 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