{"id":21345,"date":"2026-07-29T11:52:54","date_gmt":"2026-07-29T09:52:54","guid":{"rendered":"https:\/\/bio4dreams.com\/?p=21345"},"modified":"2026-07-29T13:53:14","modified_gmt":"2026-07-29T11:53:14","slug":"oacp-iso-13485-certification-quality-management","status":"publish","type":"post","link":"https:\/\/bio4dreams.com\/en\/oacp-iso-13485-certification-quality-management\/","title":{"rendered":"OaCP strengthens quality and international growth"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/bio4dreams.com\/oacp-reagenti-diagnostica-oncologica-microbiologica\/\"><strong>OaCP<\/strong><\/a> has obtained <strong>ISO 13485:2016 certification<\/strong>, a strategic milestone confirming that its Quality Management System complies with the requirements of the medical device sector.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The company, <a href=\"https:\/\/bio4dreams.com\/en\/oacp-investment-incubation-oncology-diagnostics-microbiology\/\"><strong>incubated and affiliated with Bio4Dreams<\/strong><\/a>, develops <strong>reagents and solutions for in vitro diagnostics<\/strong>, with a particular focus on oncology, cytogenetics, and molecular diagnostics.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The certification represents a further step in the company\u2019s growth journey and strengthens its management of <strong>quality and regulatory requirements<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 13485:2016 certification<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>ISO 13485:2016<\/strong> is the <strong>international reference standard<\/strong> for <strong>Quality Management Systems<\/strong> in the <strong>medical sector<\/strong>. It defines specific criteria that help organizations manage their activities in a structured manner and <strong>maintain processes aligned<\/strong> with customer needs and <strong>industry standards<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For OaCP, the certification covers the <strong>design<\/strong>, <strong>development<\/strong>, and <strong>distribution <\/strong>of <strong>in vitro diagnostic medical devices<\/strong>. Its scope includes FISH reagents and probes, molecular diagnostic reagents, PCR-based diagnostic kits, nucleic acid detection kits, rapid antigen tests, serological diagnostic devices, and products related to oncology, cytogenetic, and molecular diagnostics.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For hospitals, laboratories, research centers, and diagnostic-sector partners working with OaCP, this means relying on products developed and distributed through defined, controlled, and traceable processes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">A foundation for future development<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 13485 represents an important milestone in OaCP\u2019s journey toward compliance with the <strong>European In Vitro Diagnostic Medical Devices Regulation (IVDR)<\/strong>, which introduces a more rigorous regulatory framework for the quality, safety, and performance of <strong>in vitro diagnostic medical devices<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Building on this foundation, the company can continue its <strong>regulatory pathway<\/strong> with an increasingly robust organizational structure aligned with industry requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The certification also strengthens OaCP\u2019s operating model and supports its <strong>scalability<\/strong>, contributing to <strong>business development<\/strong> activities, the <strong>consolidation<\/strong> of <strong>partnerships<\/strong>, and <strong>growth <\/strong>in the Italian and European markets.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udcd7 Learn more about <strong>OaCP<\/strong> and the other companies in <strong><a href=\"https:\/\/bio4dreams.com\/en\/portfolio\/\" data-type=\"page\" data-id=\"12186\">our portfolio<\/a><\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>The cover image was generated using artificial intelligence for illustrative purposes and does not depict OaCP\u2019s actual facilities, personnel, or activities<\/em>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>OaCP obtains ISO 13485 certification, confirming the quality, control, and traceability of its medical device processes.<\/p>\n","protected":false},"author":8,"featured_media":21341,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[1313],"tags":[],"class_list":["post-21345","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-portfolio"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - 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