{"id":11154,"date":"2025-04-03T03:03:01","date_gmt":"2025-04-03T10:03:01","guid":{"rendered":"https:\/\/www.prfire.com\/news-releases\/4d-biomaterials-ltd-secures-iso-13485-certification\/"},"modified":"2025-04-03T03:03:01","modified_gmt":"2025-04-03T10:03:01","slug":"4d-biomaterials-ltd-secures-iso-13485-certification","status":"publish","type":"news-releases","link":"https:\/\/www.prfire.com\/news-releases\/4d-biomaterials-ltd-secures-iso-13485-certification\/","title":{"rendered":"4D Biomaterials Ltd secures ISO 13485 Certification"},"content":{"rendered":"<div class=\"trix-content\">\n<div>\n<strong>NOTTINGHAM, UK. 3rd April, 2025<\/strong> \u2013 <a href=\"https:\/\/4dmedicine.co.uk\/\" target=\"_blank\" rel=\"noopener\">4D Biomaterials Ltd<\/a>, the materials manufacturing subsidiary of 4D Medicine Ltd, a UK university spin-out company developing next-generation bioresorbable medical devices, today announced it has achieved ISO 13485:2016 certification from The British Standards Institution (BSI).\u00a0<\/p>\n<p>This globally recognised quality standard for medical device manufacturing marks a critical milestone in the company\u2019s path to market, demonstrating high quality, low risk and customer-focused manufacturing capability.\u00a0<\/p><\/div>\n<div>\n<br \/>The certification confirms that 4D Biomaterials Ltd operates under a quality management system that meets stringent international regulatory requirements \u2014 a core prerequisite for the raw materials used in medical devices seeking regulatory approvals, clinical deployment, and global distribution. As such, certification significantly de-risks the company\u2019s commercial strategy.\u00a0<\/p>\n<\/div>\n<div>\n<strong>Phil Smith, CEO of parent company<\/strong>, <strong>4D Medicine Ltd<\/strong> commented:<\/p>\n<p> <em>\u201cThis achievement is a pivotal moment for our materials manufacturing business. ISO 13485 certification validates its operational systems and sends a clear signal to partners and investors: we are ready to scale. It also reflects the maturity of our technology platform, the discipline of our team, and our commitment to executing a high-quality commercialisation strategy.\u201d<br \/><\/em>\n<\/div>\n<div>This milestone positions 4D to accelerate the development of commercial partnerships, regulatory approvals, and revenue-generating opportunities as it advances its differentiated product pipeline toward global markets.<\/p>\n<p><strong>ENDS<\/strong>\n<\/div>\n<\/div>\n","protected":false},"author":1,"featured_media":11155,"menu_order":0,"template":"","meta":{"_acf_changed":false,"content-type":"","site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":""},"news-rooms":[7317],"press-tags":[6891,7319,3307,3907,6325,7318,7320],"press-categories":[2552,6796,2522,2532],"class_list":["post-11154","news-releases","type-news-releases","status-publish","has-post-thumbnail","hentry","news-rooms-4d-medicine-limited","press-tags-3d-printing","press-tags-bioabsorbable","press-tags-biomaterials","press-tags-implant","press-tags-medical","press-tags-medical-device","press-tags-polymer","press-categories-business","press-categories-manufacturing","press-categories-medical","press-categories-science"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.prfire.com\/wp-json\/wp\/v2\/news-releases\/11154","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.prfire.com\/wp-json\/wp\/v2\/news-releases"}],"about":[{"href":"https:\/\/www.prfire.com\/wp-json\/wp\/v2\/types\/news-releases"}],"author":[{"embeddable":true,"href":"https:\/\/www.prfire.com\/wp-json\/wp\/v2\/users\/1"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.prfire.com\/wp-json\/wp\/v2\/media\/11155"}],"wp:attachment":[{"href":"https:\/\/www.prfire.com\/wp-json\/wp\/v2\/media?parent=11154"}],"wp:term":[{"taxonomy":"news-rooms","embeddable":true,"href":"https:\/\/www.prfire.com\/wp-json\/wp\/v2\/news-rooms?post=11154"},{"taxonomy":"press-tags","embeddable":true,"href":"https:\/\/www.prfire.com\/wp-json\/wp\/v2\/press-tags?post=11154"},{"taxonomy":"press-categories","embeddable":true,"href":"https:\/\/www.prfire.com\/wp-json\/wp\/v2\/press-categories?post=11154"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}