{"id":115365,"date":"2024-10-18T10:47:07","date_gmt":"2024-10-18T08:47:07","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?p=115365"},"modified":"2025-03-10T10:47:36","modified_gmt":"2025-03-10T09:47:36","slug":"gba-key2compliance-supports-bohus-with-comprehensive-cro-services","status":"publish","type":"post","link":"https:\/\/lightweb.dev\/s\/key2compliance\/news\/gba-key2compliance-supports-bohus-with-comprehensive-cro-services\/","title":{"rendered":"GBA Key2Compliance supports BOHUS with comprehensive CRO services"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"115365\" class=\"elementor elementor-115365\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-87ad922 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"87ad922\" 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-65909f0\" data-id=\"65909f0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-fa77e58 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fa77e58\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-234db20\" data-id=\"234db20\" 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-9829fc7 elementor-widget elementor-widget-heading\" data-id=\"9829fc7\" 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\">GBA Key2Compliance Enhances Quality Assurance, Regulatory Compliance, and Clinical Investigation for BOHUS <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-74e3d2f elementor-widget elementor-widget-text-editor\" data-id=\"74e3d2f\" 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 take pride in our role as the primary CRO for BOHUS, a Swedish company dedicated to producing high-quality hyaluronic acid (HA) products. Specializing in ophthalmics, aesthetics, and orthopedics, BOHUS extends its market reach to over 60 countries in the EU and MENA regions. Their commitment to excellence in HA manufacturing aims to revolutionize the market with superior products and sustainable processes.<\/p><p><strong>Comprehensive CRO Support for Clinical Regulatory Excellence<\/strong><\/p><p>To reach their ambitious goals, BOHUS relies on GBA Key2Compliance for expert guidance in regulatory compliance, quality assurance, and clinical investigations. Our partnership is instrumental in maintaining their high standards and ensuring products meet international regulatory and safety requirements.<\/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<div class=\"elementor-element elementor-element-1633bdc elementor-widget elementor-widget-text-editor\" data-id=\"1633bdc\" 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>Michelle Johansson, Head of Quality Assurance and Regulatory Affairs at BOHUS, emphasizes:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-4459643 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4459643\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-713866e\" data-id=\"713866e\" 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-02f237c elementor-widget elementor-widget-image\" data-id=\"02f237c\" 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=\"350\" height=\"350\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/Michelle_Bohus_350.avif\" class=\"attachment-large size-large wp-image-115411\" alt=\"Michelle Johansson\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/Michelle_Bohus_350.avif 350w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/Michelle_Bohus_350-300x300.avif 300w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/Michelle_Bohus_350-150x150.avif 150w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/Michelle_Bohus_350-100x100.avif 100w\" sizes=\"(max-width: 350px) 100vw, 350px\" \/>\t\t\t\t\t\t\t\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-50 elementor-inner-column elementor-element elementor-element-81608ba\" data-id=\"81608ba\" 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-6d8f91b elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"6d8f91b\" 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>&#8220;<em>GBA Key2Compliance is our main consultant in the clinical development process. They assist in developing the clinical strategy for our product portfolio, manage details in the specific study design, develops clinical investigation plans, and of course provides general clinical regulatory advice. All in all, they project manage all our clinical investigations from start to finish.&#8221;<\/em><\/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<div class=\"elementor-element elementor-element-6ed78ea elementor-widget elementor-widget-text-editor\" data-id=\"6ed78ea\" 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><strong>Ensuring Regulatory Compliance for BOHUS\u2019s Products<\/strong><\/p><p>Our expertise supports BOHUS in manufacturing and delivering HA products across three primary areas:<\/p><ul><li><strong>Ophthalmics:\u00a0<\/strong>Minivisc\u00ae Plus, an ophthalmic viscosurgical device (OVD), offers comfort and easy removal with high molecular weight and viscosity for optimum space during cataract surgery.<\/li><li><strong>Aesthetics:\u00a0<\/strong>The Decoria\u00ae dermal filler collection, featuring minimal HA molecule modification. The portfolio consists of four fillers: Decoria\u00ae Essence, Decoria\u00ae Intense, Decoria\u00ae Voluma, and Decoria\u00ae Intense Strong.<\/li><li><strong>Orthopedics:<\/strong>\u00a0Lubravisc\u00ae Bio, used in treating osteoarthritis, mimics and replaces naturally occurring HA, lubricating, and protecting cells and tissues.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-9fd6e10 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9fd6e10\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-b1f3e61\" data-id=\"b1f3e61\" 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-32d1299 elementor-widget elementor-widget-text-editor\" data-id=\"32d1299\" 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>GBA Key2Compliance ensures these medical devices meet regulatory requirements, providing support throughout the product lifecycle, including post-market surveillance.<\/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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-237c90e\" data-id=\"237c90e\" 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-66ed35c elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"66ed35c\" 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=\"409\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/bohus_hyaluronic-acid_860-2.avif\" class=\"attachment-large size-large wp-image-115437\" alt=\"Bohus Hyaluronic acid sample\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/bohus_hyaluronic-acid_860-2.avif 860w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/bohus_hyaluronic-acid_860-2-300x153.avif 300w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/bohus_hyaluronic-acid_860-2-768x393.avif 768w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/bohus_hyaluronic-acid_860-2-600x307.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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-54c6965 elementor-widget elementor-widget-text-editor\" data-id=\"54c6965\" 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><strong>Navigating Regulatory Changes<\/strong><\/p><p>The introduction of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) has increased regulatory requirements in Europe. GBA Key2Compliance has been instrumental in helping BOHUS update their documentation to maintain compliance with these stringent standards.<\/p><p><strong>Synergistic Approach to Quality and Compliance<\/strong><\/p><p>While BOHUS has a robust regulatory affairs and quality assurance department, the expertise and support from GBA Key2Compliance have proven invaluable. By partnering with GBA Key2Compliance, BOHUS ensures adherence to their quality management systems and internal procedures, while staying updated with ISO standards.<\/p><p>Michelle Johansson appreciates GBA Key2Complaince\u2019s professional approach:<br \/><em style=\"color: var( --e-global-color-text ); font-size: 1rem;\">&#8220;They speak their mind without judgment and respect our decisions. Their competence and flexibility have made them a reliable partner for many years. They genuinely aim to offer the best solutions.&#8221;<\/em><\/p><p>Jeanette Demorney, Director of Clinical Development at GBA Key2Compliance, adds:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-2a15c85 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2a15c85\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-7205712\" data-id=\"7205712\" 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-721c4e5 elementor-widget elementor-widget-image\" data-id=\"721c4e5\" 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=\"626\" height=\"800\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/jeanette_demorney_626.avif\" class=\"attachment-large size-large wp-image-115439\" alt=\"Jeanette Demorney, Director, Clinical development\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/jeanette_demorney_626.avif 626w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/jeanette_demorney_626-235x300.avif 235w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/10\/jeanette_demorney_626-600x767.avif 600w\" sizes=\"(max-width: 626px) 100vw, 626px\" \/>\t\t\t\t\t\t\t\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-50 elementor-inner-column elementor-element elementor-element-ff3b67f\" data-id=\"ff3b67f\" 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-676201d elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"676201d\" 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>&#8220;<em style=\"color: var( --e-global-color-text ); font-size: 1rem;\">We&#8217;ve been teaming up with BOHUS for several years now, and in that time, both our companies have grown. It&#8217;s truly a rare and invaluable privilege to have such a close partnership, allowing us to collaborate and support each other in meaningful ways.<\/em><\/p><p><em>Navigating the complexities of product development as a MedTech company is no walk in the park. It&#8217;s crucial to understand and adapt to each company&#8217;s unique ecosystem and needs. At GBA Key2Compliance, those of us in clinical development are driven by the potential of the products and the companies we work with, guided by our ethical compass and the regulations in place to ensure everyone who interacts with the product feels safe.<\/em><\/p><p><em>Plus, let&#8217;s be honest, we just enjoy working together. Our team meets every week, moving each study forward step by step. This is what we call the rewarding outcome of a &#8216;long-term relationship.\u201d<\/em><\/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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-84b0517 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"84b0517\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-bbde515\" data-id=\"bbde515\" 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-3891b91 elementor-widget elementor-widget-text-editor\" data-id=\"3891b91\" 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><strong>Clinical Research Organization (CRO) Services by GBA Key2Compliance<\/strong><\/p>\n<p>GBA Key2Compliance offers comprehensive MedTech CRO services to support every step of your product&#8217;s clinical development lifecycle. We assist with clinical evaluations, study design, clinical investigations, and evaluations for both existing and new products. Our services include preparing for submission to competent authorities, assisting in handling the application process, and project management throughout the study conduct, closure, and incorporation of all collected data into the clinical evaluation.<\/p>\n<p>Our team of experts ensures that your clinical investigation is conducted in accordance with the highest standards, providing robust data to support regulatory submissions and market access. Whether you are developing new medical devices or improving existing ones, our CRO services are tailored to meet your specific needs and ensure successful outcomes.<\/p>\n<p><strong>Partnering for Regulatory Success<\/strong><\/p>\n<p>At GBA Key2Compliance, we are committed to helping our clients achieve their regulatory compliance goals. Our team of consultants and industry experts offers tailored guidance, from medical device QA and regulatory affairs to clinical and product development. We also provide comprehensive training programs, including in-house, on-demand, and public courses.<\/p>\n<p>Let GBA Key2Compliance be your full-service partner, providing the expertise and guidance you need to succeed. Contact us today to learn how we can add value to your projects and help you achieve your goals.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9b1bfb elementor-widget elementor-widget-button\" data-id=\"d9b1bfb\" 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:\/\/lightweb.dev\/s\/key2compliance\/about-us\/#contact\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact GBA Key2Compliance Today<\/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\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>GBA Key2Compliance Enhances Quality Assurance, Regulatory Compliance, and Clinical Investigation for BOHUS At GBA Key2Compliance, we take pride in our role as the primary CRO for BOHUS, a Swedish company dedicated to producing high-quality hyaluronic acid (HA) products. Specializing in ophthalmics, aesthetics, and orthopedics, BOHUS extends its market reach to over 60 countries in the [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":115412,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wds_primary_category":21,"footnotes":""},"categories":[374,21,399],"tags":[313,194,301],"blog-subject":[],"class_list":["post-115365","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-customer-stories","category-news","category-testimonials","tag-clinical-investigation","tag-quality-assurance","tag-regulatory-compliance"],"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts\/115365","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/comments?post=115365"}],"version-history":[{"count":0,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts\/115365\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media\/115412"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=115365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/categories?post=115365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/tags?post=115365"},{"taxonomy":"blog-subject","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/blog-subject?post=115365"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}