{"id":69915,"date":"2021-12-15T08:17:36","date_gmt":"2021-12-15T08:17:36","guid":{"rendered":"https:\/\/key2compliance.com\/?page_id=69915"},"modified":"2026-05-20T14:36:52","modified_gmt":"2026-05-20T12:36:52","slug":"medical-device-qa","status":"publish","type":"page","link":"https:\/\/key2compliance.com\/sv\/our-services\/medical-device-qa\/","title":{"rendered":"Medicinteknisk QA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"69915\" class=\"elementor elementor-69915\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1ba7d72 e-flex e-con-boxed e-con e-parent\" data-id=\"1ba7d72\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-3db11b6 e-con-full e-flex e-con e-child\" data-id=\"3db11b6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eee9ff9 elementor-widget elementor-widget-heading\" data-id=\"eee9ff9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">QUALITY ASSURANCE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-be15c8d elementor-widget elementor-widget-heading\" data-id=\"be15c8d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Ensuring Quality and Compliance for Medical Devices<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba8ec5d elementor-widget elementor-widget-text-editor\" data-id=\"ba8ec5d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>At GBA Key2Compliance, we understand the critical role medical devices play in healthcare. We are dedicated to supporting manufacturers in delivering safe, effective, and compliant products to the market. Our approach is tailored to each client&#8217;s unique needs, ensuring a personalized and efficient service.\u00a0<\/p><p><span style=\"color: var( --e-global-color-text );\">Contact us to learn more about our services and how we can assist you in your journey towards quality and compliance excellence or just good enough.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f99d93f elementor-widget elementor-widget-spacer\" data-id=\"f99d93f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba03e5f elementor-widget elementor-widget-button\" data-id=\"ba03e5f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#contact\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-angle-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CONTACT OUR EXPERTS<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b296386 e-con-full e-flex e-con e-child\" data-id=\"b296386\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a3e6626 elementor-widget elementor-widget-spacer\" data-id=\"a3e6626\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb188fd elementor-widget elementor-widget-image\" data-id=\"fb188fd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/qa-featured-860.avif\" class=\"attachment-large size-large wp-image-87688\" alt=\"Medical Device Quality Assurance team in meeting\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/qa-featured-860.avif 860w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/qa-featured-860-300x200.avif 300w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/qa-featured-860-768x512.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/qa-featured-860-600x400.avif 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3f602ab7 e-flex e-con-boxed e-con e-parent\" data-id=\"3f602ab7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-50907fee e-con-full e-flex e-con e-child\" data-id=\"50907fee\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dde35cd elementor-widget elementor-widget-heading\" data-id=\"dde35cd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">We know the requirements - and ensure you meet them<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7f84d17 elementor-widget elementor-widget-heading\" data-id=\"7f84d17\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Learn more about our services and how we can help you<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e492531 e-con-full e-flex e-con e-child\" data-id=\"e492531\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<a class=\"elementor-element elementor-element-bf0fb88 e-con-full e-flex e-con e-child\" data-id=\"bf0fb88\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/key2compliance.com\/quality-management-system-qms\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-439c863 elementor-widget elementor-widget-heading\" data-id=\"439c863\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">QMS - Quality Management System<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-6be62f2 e-con-full e-flex e-con e-child\" data-id=\"6be62f2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/key2compliance.com\/qa-support-and-quality-manager-for-medical-devices-and-ivd\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ad4ad90 elementor-widget elementor-widget-heading\" data-id=\"ad4ad90\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">QA Support<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-354653e e-con-full e-flex e-con e-child\" data-id=\"354653e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/key2compliance.com\/qa-support-and-quality-manager-for-medical-devices-and-ivd\">\n\t\t\t\t<div class=\"elementor-element elementor-element-437217b elementor-widget elementor-widget-heading\" data-id=\"437217b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Quality Manager<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-76387bea e-con-full e-flex e-con e-child\" data-id=\"76387bea\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<a class=\"elementor-element elementor-element-7c2d0f75 e-con-full e-flex e-con e-child\" data-id=\"7c2d0f75\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/key2compliance.com\/internal-audit-services\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4a5baa41 elementor-widget elementor-widget-heading\" data-id=\"4a5baa41\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Internal Audits and<br>\nInspection readiness<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-31f1f38a e-con-full e-flex e-con e-child\" data-id=\"31f1f38a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/key2compliance.com\/prrc-person-responsible-for-regulatory-compliance\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-57e1c013 elementor-widget elementor-widget-heading\" data-id=\"57e1c013\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">PRRC - Person Responsible for Regulatory Compliance<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t<a class=\"elementor-element elementor-element-7e9b105c e-con-full e-flex e-con e-child\" data-id=\"7e9b105c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\" href=\"https:\/\/key2compliance.com\/life-cycle-management-post-market-surveillance\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e1ccd30 elementor-widget elementor-widget-heading\" data-id=\"e1ccd30\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Life Cycle Management &amp; Post Market Surveillance<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-438cc02 e-flex e-con-boxed e-con e-parent\" data-id=\"438cc02\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-d17b1f4 e-con-full e-flex e-con e-child\" data-id=\"d17b1f4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9509880 elementor-widget elementor-widget-heading\" data-id=\"9509880\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">IVDR Compliance made simple<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-42dfa20 elementor-widget elementor-widget-text-editor\" data-id=\"42dfa20\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Simplify your path to In Vitro Diagnostic Regulation (IVDR) compliance. Let us guide you through the complexities of IVDR implementation, ensuring a seamless and successful compliance experience. Don&#8217;t navigate the regulatory landscape alone \u2013 Rely on us<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-965fc28 elementor-widget elementor-widget-button\" data-id=\"965fc28\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/key2compliance.com\/ivdr-compliance-made-easy\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-angle-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">READ MORE<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d1d9f34 e-con-full e-flex e-con e-child\" data-id=\"d1d9f34\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ca61f9f elementor-widget elementor-widget-image\" data-id=\"ca61f9f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"534\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/04\/ivdr_top_image-1024x683.avif\" class=\"attachment-large size-large wp-image-84834\" alt=\"Female lab technician holding sample tube\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/04\/ivdr_top_image-1024x683.avif 1024w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/04\/ivdr_top_image-300x200.avif 300w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/04\/ivdr_top_image-768x512.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/04\/ivdr_top_image-1536x1024.avif 1536w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/04\/ivdr_top_image-600x400.avif 600w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/04\/ivdr_top_image.avif 1620w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6ebd5fb e-flex e-con-boxed e-con e-parent\" data-id=\"6ebd5fb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-105a61f e-con-full e-flex e-con e-child\" data-id=\"105a61f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e7c5f73 elementor-widget elementor-widget-image\" data-id=\"e7c5f73\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2022\/04\/kampanj-qms.avif\" class=\"attachment-large size-large wp-image-74885\" alt=\"2 female QA specialists in meeting\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2022\/04\/kampanj-qms.avif 860w, https:\/\/key2compliance.com\/wp-content\/uploads\/2022\/04\/kampanj-qms-300x200.avif 300w, https:\/\/key2compliance.com\/wp-content\/uploads\/2022\/04\/kampanj-qms-768x512.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2022\/04\/kampanj-qms-600x400.avif 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-42fdcf6 e-con-full e-flex e-con e-child\" data-id=\"42fdcf6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9692726 elementor-widget elementor-widget-heading\" data-id=\"9692726\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Simplifying your journey to MDR Compliance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f6a7a44 elementor-widget elementor-widget-text-editor\" data-id=\"f6a7a44\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Navigate the complexities of the Medical Device Regulation (MDR). With our guidance, we streamline MDR compliance with thorough gap assessments, technical documentation review, and clinical evaluation support. We help you develop a robust post-market surveillance strategy and optimize your QMS to align with MDR requirements. Our customized training programs empower your team with the knowledge and skills for MDR compliance.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-61ec780 elementor-widget elementor-widget-button\" data-id=\"61ec780\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/key2compliance.com\/qms-mdr-analysis-training-and-audit-package\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-angle-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">READ MORE<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5caaa93b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5caaa93b\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7bab307\" data-id=\"7bab307\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b05c8cb elementor-widget elementor-widget-spacer\" data-id=\"2b05c8cb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4aba9527 elementor-widget elementor-widget-heading\" data-id=\"4aba9527\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Want to learn more about the road to CE-mark for your medical device?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-551be265 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"551be265\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-a44fd45\" data-id=\"a44fd45\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-23824245 elementor-widget elementor-widget-spacer\" data-id=\"23824245\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-125f2e85 elementor-widget elementor-widget-image\" data-id=\"125f2e85\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"504\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2024\/05\/road-to-ce-mark_bl-1024x645-1-png.avif\" class=\"attachment-large size-large wp-image-101462\" alt=\"Road to CE-mark guide folder\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2024\/05\/road-to-ce-mark_bl-1024x645-1-png.avif 1024w, https:\/\/key2compliance.com\/wp-content\/uploads\/2024\/05\/road-to-ce-mark_bl-1024x645-1-300x189.avif 300w, https:\/\/key2compliance.com\/wp-content\/uploads\/2024\/05\/road-to-ce-mark_bl-1024x645-1-768x484.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2024\/05\/road-to-ce-mark_bl-1024x645-1-600x378.avif 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6423db41 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"6423db41\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/key2compliance.com\/guide-road-to-ce-mark\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-angle-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">DOWNLOAD NOW<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-inner-column elementor-element elementor-element-320175bf\" data-id=\"320175bf\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1c4b1830 elementor-widget elementor-widget-text-editor\" data-id=\"1c4b1830\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>The CE mark indicates that a product meets the applicable EU laws and allows the manufacturer to make their device available on the European market. Navigate the complexities of obtaining a CE mark for your medical device with our guide.<\/p><p>In this guide, you will find:<\/p><ul><li>Detailed Overview: A comprehensive look at the CE marking process from initial concept to market entry.<\/li><li>Regulatory Framework: Insights into the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).<\/li><li>Quality Management Essentials: Steps to establish and maintain a Quality Management System (QMS) that complies with EU standards.<\/li><li>Practical Tips: Expert advice on navigating the certification efficiently to save time and avoid common pitfalls.<\/li><\/ul><div>\u00a0<\/div><p>Download our guide and start your road to CE mark!<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t<div class=\"elementor-element elementor-element-b9a64bb e-flex e-con-boxed e-con e-parent\" data-id=\"b9a64bb\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-17a0a60 e-con-full e-flex e-con e-child\" data-id=\"17a0a60\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3e0c672 elementor-widget elementor-widget-spacer\" data-id=\"3e0c672\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c12b29d elementor-widget elementor-widget-heading\" data-id=\"c12b29d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Fulfill USA market regulations with QSR compliance  <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4c08216 elementor-widget elementor-widget-text-editor\" data-id=\"4c08216\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span class=\"TextRun SCXW180361712 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW180361712 BCX0\">Simplify your entry into the USA market with our expert guidance. We will <\/span><span class=\"NormalTextRun SCXW180361712 BCX0\">assist<\/span><span class=\"NormalTextRun SCXW180361712 BCX0\"> you in navigating the intricate FDA requirements, ensuring a seamless and successful compliance experience.<\/span> <span class=\"NormalTextRun SCXW180361712 BCX0\">Count on our support and <\/span><span class=\"NormalTextRun SCXW180361712 BCX0\">expertise<\/span><span class=\"NormalTextRun SCXW180361712 BCX0\">, so you <\/span><span class=\"NormalTextRun SCXW180361712 BCX0\">don&#8217;t<\/span><span class=\"NormalTextRun SCXW180361712 BCX0\"> have to navigate the regulatory landscape alone.<\/span><\/span><span class=\"EOP SCXW180361712 BCX0\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-35a06b7 elementor-widget elementor-widget-button\" data-id=\"35a06b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#contact\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-angle-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CONTACT US<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2077818 e-con-full e-flex e-con e-child\" data-id=\"2077818\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-451b7d6 elementor-widget elementor-widget-image\" data-id=\"451b7d6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/us-map_860.avif\" class=\"attachment-large size-large wp-image-87698\" alt=\"USA states Map\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/us-map_860.avif 860w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/us-map_860-300x200.avif 300w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/us-map_860-768x512.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/us-map_860-600x400.avif 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3ce66cb e-flex e-con-boxed e-con e-parent\" data-id=\"3ce66cb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-90d731d e-con-full e-flex e-con e-child\" data-id=\"90d731d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a698c41 elementor-widget elementor-widget-image\" data-id=\"a698c41\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/mdsap_860.avif\" class=\"attachment-large size-large wp-image-87694\" alt=\"Two females in meeting in front of a laptop\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/mdsap_860.avif 860w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/mdsap_860-300x200.avif 300w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/mdsap_860-768x512.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/mdsap_860-600x400.avif 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e0c817a e-con-full e-flex e-con e-child\" data-id=\"e0c817a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7c316e7 elementor-widget elementor-widget-heading\" data-id=\"7c316e7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDSAP Compliance made simple<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31b7935 elementor-widget elementor-widget-text-editor\" data-id=\"31b7935\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span class=\"ui-provider fy b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">Get your Quality Management System (QMS) ready for a MDSAP (Medical Device Single Audit Program) audit with our assistance. We will conduct a thorough GAP analysis, make necessary updates, and conduct a Mock audit.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-07bd84b elementor-widget elementor-widget-button\" data-id=\"07bd84b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/key2compliance.com\/quality-management-system-qms\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-angle-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">READ MORE<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3e77a6c e-flex e-con-boxed e-con e-parent\" data-id=\"3e77a6c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-980f8f1 e-con-full e-flex e-con e-child\" data-id=\"980f8f1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b0cde8b elementor-widget elementor-widget-spacer\" data-id=\"b0cde8b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31913a9 elementor-widget elementor-widget-heading\" data-id=\"31913a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Rely on us - meet our experts<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-22dbf7c elementor-widget elementor-widget-text-editor\" data-id=\"22dbf7c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>\u201cTogether with our experienced QA\/RA consultants, GBA Key2Compliance supports medical device manufacturers in building and maintaining robust quality management systems. We help companies navigate regulatory requirements, prepare for audits and inspections, and strengthen compliance throughout the product lifecycle. <br \/>Our expertise covers roles such as Quality Manager, QA\/RA, and PRRC, as well as GAP analyses, internal audits, and Notified Body audit support.\u201d<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d4935fc elementor-widget elementor-widget-text-editor\" data-id=\"d4935fc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Olivia Sun, Consultant manager<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e171206 elementor-widget elementor-widget-button\" data-id=\"e171206\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#contact\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-angle-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CONTACT OUR EXPERTS<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6db6bff elementor-widget elementor-widget-spacer\" data-id=\"6db6bff\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1fce59f e-con-full e-flex e-con e-child\" data-id=\"1fce59f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6017eda elementor-widget elementor-widget-image\" data-id=\"6017eda\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"828\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/05\/olivia_frilagd_bord-768x828.avif\" class=\"attachment-medium_large size-medium_large wp-image-133460\" alt=\"Olivia Sun, Consultant manager\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/05\/olivia_frilagd_bord-768x828.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/05\/olivia_frilagd_bord-278x300.avif 278w, https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/05\/olivia_frilagd_bord-600x647.avif 600w, https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/05\/olivia_frilagd_bord.avif 928w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-173302b7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"173302b7\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3d737d8\" data-id=\"3d737d8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d6cd632 elementor-widget elementor-widget-spacer\" data-id=\"d6cd632\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c7d16d9 elementor-widget elementor-widget-heading\" data-id=\"2c7d16d9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Related material<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ea4fe8e elementor-widget elementor-widget-spacer\" data-id=\"ea4fe8e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f35811f elementor-testimonial--layout-image_above elementor-testimonial--align-left elementor-testimonial--skin-default elementor-arrows-yes elementor-pagination-type-bullets elementor-widget elementor-widget-testimonial-carousel\" data-id=\"2f35811f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;slides_per_view&quot;:&quot;3&quot;,&quot;autoplay_speed&quot;:4000,&quot;show_arrows&quot;:&quot;yes&quot;,&quot;pagination&quot;:&quot;bullets&quot;,&quot;speed&quot;:500,&quot;autoplay&quot;:&quot;yes&quot;,&quot;loop&quot;:&quot;yes&quot;,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;space_between&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;space_between_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;space_between_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]}}\" data-widget_type=\"testimonial-carousel.default\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-main-swiper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Slides\">\n\t\t\t\t<div class=\"swiper-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial\">\n\t\t\t\t\t\t\t<div class=\"elementor-testimonial__content\">\n\t\t\t\t\t<div class=\"elementor-testimonial__text\">\n\t\t\t\t\t\t<b>Webinar - \nWhat about Change Management?<\/b><br>A theoretic and practical solution to your Change management issues.<br><br><b><a href=\"https:\/\/vimeo.com\/936573023\/\">Play recording ><\/a><\/b>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-testimonial__footer\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial__image\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2024\/09\/change-mgmnt-caro-bl-png.avif\" alt=\"What about change management\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial\">\n\t\t\t\t\t\t\t<div class=\"elementor-testimonial__content\">\n\t\t\t\t\t<div class=\"elementor-testimonial__text\">\n\t\t\t\t\t\t<b>Internal audits \u2013 an opportunity to improve medical devices<\/b><br>Meet Oscar He, our Senior Consultant and Coordinating Manager for internal audits!<br><br><b><a href=\"https:\/\/key2compliance.com\/news\/meet-oscar-he-our-senior-consultant-and-coordinating-manager-for-internal-audits\/\">Read article ><\/a><\/b>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-testimonial__footer\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial__image\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/01\/Oscar_He_3_800.avif\" alt=\"Oscar He\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial\">\n\t\t\t\t\t\t\t<div class=\"elementor-testimonial__content\">\n\t\t\t\t\t<div class=\"elementor-testimonial__text\">\n\t\t\t\t\t\t<b>What you need to know about the new required role of Person Responsible for Regulatory Compliance!<\/b><br>Learn what PRRC Means for Manufacturers of Medical Devices <br><br><b><a href=\"https:\/\/key2compliance.com\/articles\/the-new-required-role-of-person-responsible-for-regulatory-compliance\/\">Read article ><\/a><\/b>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-testimonial__footer\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial__image\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/02\/prrc_article.avif\" alt=\"Two regulatory specialists discussing a case in front of acomputer screen.\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial\">\n\t\t\t\t\t\t\t<div class=\"elementor-testimonial__content\">\n\t\t\t\t\t<div class=\"elementor-testimonial__text\">\n\t\t\t\t\t\t<b>Webinar - \nWhat about CAPA?<\/b><br>Do you have a systematic approach to identifying, addressing, and preventing issues that could impact product quality or patient safety? <br><br><b><a href=\"https:\/\/vimeo.com\/893326775\/\">Play recording ><\/a><\/b>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-testimonial__footer\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial__image\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/12\/capa-caro-bl-png.avif\" alt=\"Whata about CAPA? Webinar\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial\">\n\t\t\t\t\t\t\t<div class=\"elementor-testimonial__content\">\n\t\t\t\t\t<div class=\"elementor-testimonial__text\">\n\t\t\t\t\t\t<b>Webinar - Is your medical device software MDR ready?<\/b><br><br><b><a href=\"https:\/\/vimeo.com\/658512925\/\">Play recording ><\/a><\/b>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-testimonial__footer\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial__image\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/software-mdr-ready-caro-bl-png.avif\" alt=\"\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial\">\n\t\t\t\t\t\t\t<div class=\"elementor-testimonial__content\">\n\t\t\t\t\t<div class=\"elementor-testimonial__text\">\n\t\t\t\t\t\t<b>Webinar - Medical Device software life cycle processes - IEC 62304 an overview<\/b><br><br><b><a href=\"https:\/\/vimeo.com\/507434373\/\">Play recording ><\/a><\/b>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-testimonial__footer\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-testimonial__image\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2023\/07\/sw-life-cycle-caro-bl-png.avif\" alt=\"\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-prev\" role=\"button\" tabindex=\"0\" aria-label=\"F\u00f6reg\u00e5ende\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-chevron-left\"><\/i>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-next\" role=\"button\" tabindex=\"0\" aria-label=\"N\u00e4sta\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-chevron-right\"><\/i>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-pagination\"><\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-78d0b14 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"78d0b14\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-9b6f307\" data-id=\"9b6f307\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1041deea elementor-widget elementor-widget-menu-anchor\" data-id=\"1041deea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"contact\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20508891 elementor-widget elementor-widget-heading\" data-id=\"20508891\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Get In Touch With Our Experts<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f639e2e elementor-widget elementor-widget-text-editor\" data-id=\"f639e2e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>We have dedicated experts of every service of our business. Feel free to leave your contact details and we will find the right solution just for you.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-126b6e20 elementor-button-align-end elementor-mobile-button-align-center elementor-widget elementor-widget-form\" data-id=\"126b6e20\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Next&quot;,&quot;step_previous_label&quot;:&quot;Previous&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"Webform MedDev QA\" aria-label=\"Webform MedDev QA\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"69915\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"126b6e20\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Medical Medical Device QA | QA Experts | GBA Key2Compliance\" \/>\n\n\t\t\t\t\t\t\t<input type=\"hidden\" name=\"queried_id\" value=\"69915\"\/>\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-formid elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[formid]\" id=\"form-field-formid\" class=\"elementor-field elementor-size-md  elementor-field-textual\" value=\"Webform MedDev QA\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-firstname elementor-col-33 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-firstname\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tFirstName\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[firstname]\" id=\"form-field-firstname\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"First name\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-lastname elementor-col-33 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-lastname\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tLastName\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[lastname]\" id=\"form-field-lastname\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Last name\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-field_4f56078 elementor-col-33\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_4f56078\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tTitle\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[field_4f56078]\" id=\"form-field-field_4f56078\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Title\/position\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-company elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-company\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tCompany\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[company]\" id=\"form-field-company\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Company\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tEmail\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Your Email\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-tel elementor-field-group elementor-column elementor-field-group-phone elementor-col-50\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-phone\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tPhone\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<input size=\"1\" type=\"tel\" name=\"form_fields[phone]\" id=\"form-field-phone\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Phone\" pattern=\"[0-9()#&amp;+*-=.]+\" title=\"Endast siffror och telefontecken (#, -, *, etc) accepteras.\">\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-select elementor-field-group elementor-column elementor-field-group-interest elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-interest\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tInterest\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field elementor-select-wrapper remove-before \">\n\t\t\t<div class=\"select-caret-down-wrapper\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-caret-down\"><\/i>\t\t\t<\/div>\n\t\t\t<select name=\"form_fields[interest]\" id=\"form-field-interest\" class=\"elementor-field-textual elementor-size-md\" required=\"required\">\n\t\t\t\t\t\t\t\t\t<option value=\"\">I&#039;m contacting you regarding....<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"biotox\">Biological Evaluations &amp; Toxicology<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"clin\">Clinical Development<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"mdqa\">Quality Assurance<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"ra\">Regulatory Affairs<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"pharmaqa\">Pharma QA<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"public\">Public Courses<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"inhouse\">Inhouse training<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"ondemand\">On-demand training<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"avatar\">Avatar training<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"other\">Other<\/option>\n\t\t\t\t\t\t\t<\/select>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tMessage\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-md\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"3\" placeholder=\"How can we help you?\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-html elementor-field-group elementor-column elementor-field-group-field_ec9c3a2 elementor-col-75\">\n\t\t\t\t\tWe take great care of your contact details. To learn more, read our <a href=\"\/policies-cookies\">Privacy Policy<\/a>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-recaptcha_v3 elementor-field-group elementor-column elementor-field-group-field_ca2340e elementor-col-100 recaptcha_v3-bottomright\">\n\t\t\t\t\t<div class=\"elementor-field\" id=\"form-field-field_ca2340e\"><div class=\"elementor-g-recaptcha\" data-sitekey=\"6Le7F6ggAAAAAAbZrrur_hWj9nDcJd986S-LniFR\" data-type=\"v3\" data-action=\"Form\" data-badge=\"bottomright\" data-size=\"invisible\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-100 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-arrow-right\"><\/i>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Send now<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/form>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-41eb7cd9\" data-id=\"41eb7cd9\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>QUALITY ASSURANCE Ensuring Quality and Compliance for Medical Devices At GBA Key2Compliance, we understand the critical role medical devices play in healthcare. We are dedicated to supporting manufacturers in delivering safe, effective, and compliant products to the market. Our approach is tailored to each client&#8217;s unique needs, ensuring a personalized and efficient service.\u00a0 Contact us [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":87688,"parent":34,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-69915","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/pages\/69915","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/comments?post=69915"}],"version-history":[{"count":5,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/pages\/69915\/revisions"}],"predecessor-version":[{"id":133532,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/pages\/69915\/revisions\/133532"}],"up":[{"embeddable":true,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/pages\/34"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/media\/87688"}],"wp:attachment":[{"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/media?parent=69915"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}