{"id":2380,"date":"2026-03-20T11:01:51","date_gmt":"2026-03-20T10:01:51","guid":{"rendered":"https:\/\/www.bayoocare.com\/regulatory-update-current-issue\/"},"modified":"2026-03-20T11:01:51","modified_gmt":"2026-03-20T10:01:51","slug":"regulatory-update-current-issue","status":"publish","type":"page","link":"https:\/\/www.bayoocare.com\/en\/regulatory-update-current-issue\/","title":{"rendered":"Regulatory Update &#8211; Current issue"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling fusion-no-medium-visibility fusion-no-large-visibility\" 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-padding-top-small:0px;--awb-margin-top-medium:0px;--awb-margin-top-small:-45px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 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:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element sm-text-align-center\" style=\"--awb-aspect-ratio:3 \/ 2;--awb-margin-right-small:-30px;--awb-margin-left-small:-30px;--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 has-aspect-ratio\"><img decoding=\"async\" width=\"2560\" height=\"1463\" title=\"Startseite Platzhalter KI generiert\" src=\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/02\/Startseite-Platzhalter-KI-generiert-scaled.jpg\" class=\"img-responsive wp-image-73 img-with-aspect-ratio\" data-parent-fit=\"cover\" data-parent-container=\".fusion-image-element\" alt srcset=\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/02\/Startseite-Platzhalter-KI-generiert-200x114.jpg 200w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/02\/Startseite-Platzhalter-KI-generiert-400x229.jpg 400w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/02\/Startseite-Platzhalter-KI-generiert-600x343.jpg 600w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/02\/Startseite-Platzhalter-KI-generiert-800x457.jpg 800w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/02\/Startseite-Platzhalter-KI-generiert-1200x686.jpg 1200w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/02\/Startseite-Platzhalter-KI-generiert-scaled.jpg 2560w\" sizes=\"(max-width: 1100px) 100vw, 1200px\" \/><\/span><\/div><\/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:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0%;--awb-margin-bottom-small:0px;--awb-spacing-left-small:0%;\"><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-1 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-color8);--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:35;line-height:var(--awb-typography1-line-height);\">Current developments in regulation and legal practice<\/h2><\/div><div class=\"fusion-text fusion-text-1\" style=\"--awb-text-color:var(--awb-color8);\"><p>Every month, we prepare the most relevant developments from MDR, IVDR, data protection and related legal areas for you &#8211; with a practical focus and without detours. You can find the latest articles directly here. <\/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=\"--button-border-radius-top-left:60px;--button-border-radius-top-right:60px;--button-border-radius-bottom-right:60px;--button-border-radius-bottom-left:60px;\" target=\"_self\" href=\"#contact\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Contact us now<\/span><\/a><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling fusion-no-small-visibility\" 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-margin-top:-60px;--awb-margin-bottom:60px;--awb-margin-top-medium:-50px;--awb-margin-bottom-medium:0px;--awb-background-color:rgba(217,213,220,0.43);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_2 1_2 fusion-flex-column fusion-flex-align-self-center\" style=\"--awb-padding-top:50px;--awb-padding-right:50px;--awb-padding-bottom:50px;--awb-padding-left:0%;--awb-overflow:hidden;--awb-bg-size:cover;--awb-border-radius:0px 60px 60px 0px;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-center fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-one\" style=\"--awb-text-color:var(--awb-color8);--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h1 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:42;line-height:var(--awb-typography1-line-height);\">Current developments in regulation and legal practice<\/h1><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-color:var(--awb-color8);\"><p>Every month, we prepare the most relevant developments from MDR, IVDR, data protection and related legal areas for you &#8211; with a practical focus and without detours. You can find the latest articles directly here. <\/p>\n<\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-2 fusion-button-default-span fusion-button-default-type\" style=\"--button-border-radius-top-left:60px;--button-border-radius-top-right:60px;--button-border-radius-bottom-right:60px;--button-border-radius-bottom-left:60px;\" target=\"_self\" href=\"#contact\"><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 fusion-builder-column-3 fusion_builder_column_1_2 1_2 fusion-flex-column fusion-flex-align-self-center\" style=\"--awb-z-index:-1;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:50px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:50px;--awb-spacing-left-large:0%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-center fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-aspect-ratio:3 \/ 2;--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-2 hover-type-none has-aspect-ratio\" style=\"border-radius:6px;\"><img decoding=\"async\" width=\"1024\" height=\"585\" title=\"BAYOOCARE_Regulatory Update Newsletter\" src=\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE_Regulatory-Update-Newsletter-1024x585.jpg\" class=\"img-responsive wp-image-2094 img-with-aspect-ratio\" data-parent-fit=\"cover\" data-parent-container=\".fusion-image-element\" alt srcset=\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE_Regulatory-Update-Newsletter-200x114.jpg 200w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE_Regulatory-Update-Newsletter-400x229.jpg 400w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE_Regulatory-Update-Newsletter-600x343.jpg 600w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE_Regulatory-Update-Newsletter-800x457.jpg 800w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE_Regulatory-Update-Newsletter-1200x686.jpg 1200w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE_Regulatory-Update-Newsletter.jpg 1792w\" sizes=\"(max-width: 1100px) 100vw, 800px\" \/><\/span><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background 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-margin-top:0px;--awb-margin-top-medium:20px;--awb-margin-top-small:30px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_1 1_1 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0%;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-center fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:35;line-height:var(--awb-typography1-line-height);\">The current articles in this issue<\/h2><\/div><div class=\"fusion-text fusion-text-3\"><p>Three topics that MedTech companies and medical device manufacturers are currently dealing with &#8211; categorized by our regulatory experts<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-4 fusion-flex-container has-pattern-background has-mask-background 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-margin-top:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion-flex-column\" style=\"--awb-padding-left:35vw;--awb-padding-left-small:25px;--awb-overflow:hidden;--awb-bg-color:var(--awb-color3);--awb-bg-color-hover:var(--awb-color3);--awb-bg-size:cover;--awb-border-radius:0px 60px 60px 0px;--awb-width-large:120%;--awb-margin-top-large:60px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:-35vw;--awb-width-medium:120%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:-35vw;--awb-width-small:110%;--awb-order-small:0;--awb-margin-top-small:20px;--awb-spacing-right-small:0%;--awb-spacing-left-small:-25px;\"><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-4 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:35;line-height:1.2;\">Regulatory safety for medical devices &#8211; that is our core business<\/h2><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_1_1 1_1 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:60px;--awb-spacing-right-large:0.96%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0.96%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-margin-top-small:20px;--awb-spacing-right-small:0%;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-center fusion-content-layout-column\"><div class=\"fusion-text fusion-text-4\"><p>BAYOOCARE supports MedTech companies, pharmaceutical companies and international manufacturers from the initial product idea to worldwide market approval. As a certified legal manufacturer in accordance with MDR and IVDR, we assume full regulatory responsibility &#8211; so that you can concentrate on development and sales. <\/p>\n<p>The Regulatory Update is part of our commitment to keeping our customers and partners up to date at all times &#8211; because regulatory knowledge is a decisive competitive advantage today.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-7 fusion_builder_column_1_3 1_3 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:30px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0%;--awb-width-medium:33.333333333333%;--awb-order-medium:0;--awb-spacing-right-medium:5.76%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-margin-top-small:0px;--awb-spacing-right-small:0%;--awb-spacing-left-small:0%;\"><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-5 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Legal Manufacturer as a Service<\/h3><\/div><div class=\"fusion-text fusion-text-5 fusion-text-no-margin\" style=\"--awb-margin-bottom:25px;\"><p>Full manufacturer responsibility according to MDR\/IVDR &#8211; including CE marking, technical documentation and post-market surveillance.<\/p>\n<\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;flex-grow:1;width:100%;\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-8 fusion_builder_column_1_3 1_3 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:30px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0%;--awb-width-medium:33.333333333333%;--awb-order-medium:0;--awb-spacing-right-medium:5.76%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-margin-top-small:0px;--awb-spacing-right-small:0%;--awb-spacing-left-small:0%;\"><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-6 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">International market approval<\/h3><\/div><div class=\"fusion-text fusion-text-6 fusion-text-no-margin\" style=\"--awb-margin-bottom:25px;\"><p>From the EU to the USA and Australia to Asian and Middle Eastern markets &#8211; we know the requirements and the right local partners.<\/p>\n<\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;flex-grow:1;width:100%;\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-9 fusion_builder_column_1_3 1_3 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:30px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0%;--awb-width-medium:33.333333333333%;--awb-order-medium:0;--awb-spacing-right-medium:5.76%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-margin-top-small:0px;--awb-spacing-right-small:0%;--awb-spacing-left-small:0%;\"><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-7 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">ISO 13485 &amp; MDSAP certification<\/h3><\/div><div class=\"fusion-text fusion-text-7 fusion-text-no-margin\" style=\"--awb-margin-bottom:25px;\"><p>Our certifications enable simplified approval procedures in Australia, Brazil, Canada, Japan and the USA.<\/p>\n<\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;flex-grow:1;width:100%;\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-5 fusion-flex-container has-pattern-background has-mask-background 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-margin-top:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-10 fusion_builder_column_1_3 1_3 fusion-flex-column fusion-flex-align-self-center fusion-no-small-visibility\" style=\"--awb-padding-top:50px;--awb-padding-right:50px;--awb-padding-bottom:50px;--awb-padding-left:50px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom_color_2);--awb-bg-color-hover:var(--awb-custom_color_2);--awb-bg-size:cover;--awb-border-radius:60px 0px 0px 60px;--awb-width-large:33.333333333333%;--awb-margin-top-large:60px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0%;--awb-width-medium:33.333333333333%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start 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:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-0 fusion_builder_column_inner_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><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-3 hover-type-none\" style=\"border-radius:100px;\"><img decoding=\"async\" width=\"776\" height=\"776\" alt=\"BAYOOCARE - Alfred Koch - CEO &amp; PRRC\" title=\"BAYOOCARE &#8211; Alfred Koch &#8211; CEO &amp; PRRC\" src=\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Alfred-Koch-CEO-PRRC.png\" class=\"img-responsive wp-image-51\" srcset=\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Alfred-Koch-CEO-PRRC-200x200.png 200w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Alfred-Koch-CEO-PRRC-400x400.png 400w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Alfred-Koch-CEO-PRRC-600x600.png 600w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Alfred-Koch-CEO-PRRC.png 776w\" sizes=\"(max-width: 1100px) 100vw, 400px\" \/><\/span><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-1 fusion_builder_column_inner_3_4 3_4 fusion-flex-column fusion-flex-align-self-center\" style=\"--awb-bg-size:cover;--awb-width-large:75%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.56%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:2.56%;--awb-width-medium:75%;--awb-order-medium:0;--awb-spacing-right-medium:2.56%;--awb-spacing-left-medium:2.56%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><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-8\" style=\"--awb-line-height:0.5;--awb-text-color:var(--awb-color8);\"><p><strong>Alfred Koch<\/strong><\/p>\n<p>CEO | PRRC<\/p>\n<\/div><\/div><\/div><\/div><div class=\"fusion-title title fusion-title-8 fusion-sep-none fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color8);--awb-margin-top:50px;--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:24;line-height:var(--awb-typography1-line-height);\">How to contact us<\/h4><\/div><div class=\"fusion-text fusion-text-9\" style=\"--awb-text-color:var(--awb-color8);\"><p>Are you planning a project or do you have very specific regulatory questions about placing your medical device on the market? No matter what phase of your project you are in, we will be happy to support you.  The quickest way to reach us &#8211; feel free to write to us.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-11 fusion_builder_column_2_3 2_3 fusion-flex-column\" style=\"--awb-padding-top:50px;--awb-padding-right:50px;--awb-padding-bottom:50px;--awb-padding-left:50px;--awb-padding-top-small:25px;--awb-padding-right-small:30px;--awb-padding-bottom-small:25px;--awb-padding-left-small:30px;--awb-overflow:hidden;--awb-bg-color:var(--awb-color3);--awb-bg-color-hover:var(--awb-color3);--awb-bg-size:cover;--awb-border-radius:60px 60px 60px 60px;--awb-width-large:66.666666666667%;--awb-margin-top-large:60px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0%;--awb-width-medium:66.666666666667%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0%;--awb-margin-bottom-small:0px;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-menu-anchor\" id=\"contact\"><\/div><div class=\"fusion-title title fusion-title-9 fusion-sep-none fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-left:30px;--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:20px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:24;line-height:var(--awb-typography1-line-height);\">Contact form<\/h4><\/div><div class=\"fusion-form fusion-form-builder fusion-form-form-wrapper fusion-form-2413\" style=\"--awb-tooltip-text-color:#ffffff;--awb-tooltip-background-color:#333333;--awb-form-label-color:var(--awb-color1);--awb-form-border-color:var(--awb-color1);--awb-form-focus-border-color:var(--awb-color2);--awb-form-focus-border-hover-color:hsla(var(--awb-color2-h),var(--awb-color2-s),var(--awb-color2-l),calc(var(--awb-color2-a) - 50%));\" data-form-id=\"2413\" data-config=\"{&quot;form_id&quot;:2413,&quot;form_post_id&quot;:2413,&quot;post_id&quot;:2380,&quot;form_type&quot;:&quot;ajax&quot;,&quot;confirmation_type&quot;:&quot;message&quot;,&quot;redirect_url&quot;:&quot;&quot;,&quot;redirect_timeout&quot;:&quot;0&quot;,&quot;field_labels&quot;:{&quot;vorname&quot;:&quot;First name&quot;,&quot;nachname&quot;:&quot;Name&quot;,&quot;unternehmen&quot;:&quot;Company&quot;,&quot;position&quot;:&quot;Position&quot;,&quot;e-mail-adresse&quot;:&quot;E-mail&quot;,&quot;telefonnummer&quot;:&quot;Phone&quot;,&quot;bevorzugte_kontaktmethode&quot;:&quot;Preferred contact method&quot;,&quot;fragen_oder_projektvorhaben&quot;:&quot;Your questions or comments&quot;,&quot;datenschutzhinweis&quot;:&quot;Data protection notice&quot;},&quot;field_logics&quot;:{&quot;vorname&quot;:&quot;&quot;,&quot;nachname&quot;:&quot;&quot;,&quot;unternehmen&quot;:&quot;&quot;,&quot;position&quot;:&quot;&quot;,&quot;e-mail-adresse&quot;:&quot;&quot;,&quot;telefonnummer&quot;:&quot;&quot;,&quot;bevorzugte_kontaktmethode&quot;:&quot;&quot;,&quot;fragen_oder_projektvorhaben&quot;:&quot;&quot;,&quot;datenschutzhinweis&quot;:&quot;&quot;,&quot;submit_1&quot;:&quot;&quot;,&quot;notice_1&quot;:&quot;&quot;},&quot;field_types&quot;:{&quot;vorname&quot;:&quot;text&quot;,&quot;nachname&quot;:&quot;text&quot;,&quot;unternehmen&quot;:&quot;text&quot;,&quot;position&quot;:&quot;text&quot;,&quot;e-mail-adresse&quot;:&quot;email&quot;,&quot;telefonnummer&quot;:&quot;phone_number&quot;,&quot;bevorzugte_kontaktmethode&quot;:&quot;radio&quot;,&quot;fragen_oder_projektvorhaben&quot;:&quot;textarea&quot;,&quot;datenschutzhinweis&quot;:&quot;checkbox&quot;,&quot;submit_1&quot;:&quot;submit&quot;,&quot;notice_1&quot;:&quot;notice&quot;},&quot;nonce_method&quot;:&quot;ajax&quot;,&quot;form_views&quot;:&quot;ajax&quot;,&quot;form_views_counting&quot;:&quot;all&quot;}\"><form action=\"https:\/\/www.bayoocare.com\/en\/regulatory-update-current-issue\/\" method=\"post\" class=\"fusion-form fusion-form-2413\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-5-1 fusion-flex-container has-pattern-background has-mask-background 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-padding-right-small:0px;--awb-padding-left-small:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-12 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-flex-grow:0;--awb-flex-shrink:0;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-flex-grow-medium:;--awb-flex-shrink-medium:;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-flex-grow-small:;--awb-flex-shrink-small:;--awb-spacing-right-small:0%;--awb-margin-bottom-small:-20px;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-form-field fusion-form-text-field fusion-form-label-above\" style=\"\" data-form-id=\"2413\"><div class=\"fusion-form-label-wrapper\"><label for=\"vorname\">First name <abbr class=\"fusion-form-element-required\" title=\"required\">*<\/abbr><\/label><\/div><input type=\"text\" autocomplete=\"off\" name=\"vorname\" id=\"vorname\" value=\"\"  class=\"fusion-form-input\" required=\"true\" aria-required=\"true\" data-holds-private-data=\"false\" minlength=\"0\"\/><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-13 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-flex-grow:0;--awb-flex-shrink:0;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-flex-grow-medium:;--awb-flex-shrink-medium:;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-flex-grow-small:;--awb-flex-shrink-small:;--awb-margin-top-small:0px;--awb-spacing-right-small:0%;--awb-margin-bottom-small:-20px;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-form-field fusion-form-text-field fusion-form-label-above\" style=\"\" data-form-id=\"2413\"><div class=\"fusion-form-label-wrapper\"><label for=\"nachname\">Name <abbr class=\"fusion-form-element-required\" title=\"required\">*<\/abbr><\/label><\/div><input type=\"text\" autocomplete=\"off\" name=\"nachname\" id=\"nachname\" value=\"\"  class=\"fusion-form-input\" required=\"true\" aria-required=\"true\" data-holds-private-data=\"false\" minlength=\"0\"\/><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-14 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-flex-grow:0;--awb-flex-shrink:0;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-flex-grow-medium:;--awb-flex-shrink-medium:;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-flex-grow-small:;--awb-flex-shrink-small:;--awb-spacing-right-small:0%;--awb-margin-bottom-small:-20px;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-form-field fusion-form-text-field fusion-form-label-above\" style=\"\" data-form-id=\"2413\"><div class=\"fusion-form-label-wrapper\"><label for=\"unternehmen\">Company <abbr class=\"fusion-form-element-required\" title=\"required\">*<\/abbr><\/label><\/div><input type=\"text\" autocomplete=\"off\" name=\"unternehmen\" id=\"unternehmen\" value=\"\"  class=\"fusion-form-input\" required=\"true\" aria-required=\"true\" data-holds-private-data=\"false\" minlength=\"0\"\/><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-15 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-flex-grow:0;--awb-flex-shrink:0;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-flex-grow-medium:;--awb-flex-shrink-medium:;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-flex-grow-small:;--awb-flex-shrink-small:;--awb-spacing-right-small:0%;--awb-margin-bottom-small:-20px;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-form-field fusion-form-text-field fusion-form-label-above\" style=\"\" data-form-id=\"2413\"><div class=\"fusion-form-label-wrapper\"><label for=\"position\">Position<\/label><\/div><input type=\"text\" autocomplete=\"off\" name=\"position\" id=\"position\" value=\"\"  class=\"fusion-form-input\" data-holds-private-data=\"false\" minlength=\"0\"\/><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-16 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-flex-grow:0;--awb-flex-shrink:0;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-flex-grow-medium:;--awb-flex-shrink-medium:;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-flex-grow-small:;--awb-flex-shrink-small:;--awb-spacing-right-small:0%;--awb-margin-bottom-small:-20px;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-form-field fusion-form-email-field fusion-form-label-above\" style=\"\" data-form-id=\"2413\"><div class=\"fusion-form-label-wrapper\"><label for=\"e-mail-adresse\">E-mail <abbr class=\"fusion-form-element-required\" title=\"required\">*<\/abbr><\/label><\/div><div class=\"fusion-form-input-with-icon\"><i class=\"awb-form-icon fa-envelope fas\"><\/i><input type=\"email\" autocomplete=\"off\" name=\"e-mail-adresse\" id=\"e-mail-adresse\" value=\"\"  class=\"fusion-form-input\" required=\"true\" aria-required=\"true\" data-holds-private-data=\"false\"\/><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-17 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-flex-grow:0;--awb-flex-shrink:0;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-flex-grow-medium:;--awb-flex-shrink-medium:;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-flex-grow-small:;--awb-flex-shrink-small:;--awb-spacing-right-small:0%;--awb-margin-bottom-small:-20px;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-form-field fusion-form-phone-number-field fusion-form-label-above\" style=\"\" data-form-id=\"2413\"><div class=\"fusion-form-label-wrapper\"><label for=\"telefonnummer\">Phone<\/label><\/div><div class=\"fusion-form-input-with-icon\"><i class=\"awb-form-icon fa-phone-alt fas\"><\/i><input type=\"tel\" autocomplete=\"off\" name=\"telefonnummer\" id=\"telefonnummer\" value=\"\"  class=\"fusion-form-input\" data-holds-private-data=\"false\"\/><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-18 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-flex-grow:0;--awb-flex-shrink:0;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-flex-grow-medium:;--awb-flex-shrink-medium:;--awb-spacing-right-medium:0%;--awb-margin-bottom-medium:0px;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-flex-grow-small:;--awb-flex-shrink-small:;--awb-spacing-right-small:0%;--awb-margin-bottom-small:0px;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start 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