{"id":1200,"date":"2025-02-26T14:20:46","date_gmt":"2025-02-26T14:20:46","guid":{"rendered":"https:\/\/expanite.com?p=1200"},"modified":"2025-04-11T09:48:20","modified_gmt":"2025-04-11T09:48:20","slug":"master-file-for-devices","status":"publish","type":"post","link":"https:\/\/expanite.com\/it\/master-file-medici\/","title":{"rendered":"Expanite riceve il Master File per dispositivi medici (articolo in inglese)"},"content":{"rendered":"<div class=\"wp-block-image\">\r\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"600\" height=\"283\" class=\"wp-image-1207\" style=\"width: 600px;\" src=\"https:\/\/expanite.com\/wp-content\/uploads\/2025\/02\/MAF_FDA_Expanite.png\" alt=\"Expanite Recieves Master File for Devices\" srcset=\"https:\/\/expanite.com\/wp-content\/uploads\/2025\/02\/MAF_FDA_Expanite.png 866w, https:\/\/expanite.com\/wp-content\/uploads\/2025\/02\/MAF_FDA_Expanite-300x142.png 300w, https:\/\/expanite.com\/wp-content\/uploads\/2025\/02\/MAF_FDA_Expanite-768x363.png 768w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/figure>\r\n<\/div> \r\n<p class=\"has-text-color has-link-color wp-elements-1 wp-block-paragraph\" style=\"color: #256820;\"><strong><em>Expanite\u00ae receives Master File for Devices (MAF) acknowledgment letter from FDA on their patented process for surface hardening of stainless steel in medical devices applications. and solving some of their challenges with wear on the titanium parts in their racing car.<\/em><\/strong><\/p>\r\n Expanite announces it has submitted a Master File for Devices (MAF) to the United States Food &amp; Drug Administration (FDA) and has now been issued the submission number MAF3078.\r\n\r\n Expanite has successfully submitted a Master File for Devices (MAF) to the Center for Devices and Radiological Health (CDRH) at the FDA for SuperExpanite\u00ae, their patented process for surface hardening of stainless steel and received an Acknowledgment letter from FDA confirming submission filing. The MAF covers necessary information such as technology, production processes and facility information, as well as test data and more. The SuperExpanite Master File has been issued submission document control number MAF3078.\r\n\r\n \u201cWe are very pleased to have achieved this significant milestone. The FDA registration makes it easier for our U.S. customers to obtain approval for new medical products that use Expanite surface hardening. Expanite is now able to provide a signed and named Authorization letter to our customers on their request, for the purpose of their product registrations at FDA. This is the first of many MAFs to come\u201d says Expanite CEO, Thomas Abel Sandholdt.\r\n\r\n \r\n<h2 class=\"wp-block-heading has-text-color has-link-color wp-elements-2\" style=\"color: #256820;\"><em>Benefits of MAF implementation<\/em><\/h2>\r\n The advantages of the MAF being submitted at FDA for the manufacturers who utilize Expanite surface hardening technology and register their products at FDA are many e.g.:\r\n\r\n \r\n<ul class=\"wp-block-list\">\r\n \t<li style=\"list-style-type: none;\">\r\n<ul class=\"wp-block-list\">\r\n \t<li>Expanite, individually, invested time to search and understand the FDA requirements for MAF submission<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n \r\n<ul class=\"wp-block-list\">\r\n \t<li style=\"list-style-type: none;\">\r\n<ul class=\"wp-block-list\">\r\n \t<li>Documentation compiled, as required, and submission confirmed by FDA.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n \r\n<ul class=\"wp-block-list\">\r\n \t<li style=\"list-style-type: none;\">\r\n<ul class=\"wp-block-list\">\r\n \t<li>Surface hardening technology documentation available for FDA\u2019s review as of now.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n \r\n<ul class=\"wp-block-list\">\r\n \t<li style=\"list-style-type: none;\">\r\n<ul class=\"wp-block-list\">\r\n \t<li>Eliminates communication time and effort between manufacturer and Expanite on MAF build and requirements.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n \r\n<ul class=\"wp-block-list\">\r\n \t<li style=\"list-style-type: none;\">\r\n<ul class=\"wp-block-list\">\r\n \t<li>Expanite responsible to maintain MAF up to date, as appropriate.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n\r\n\r\n \r\n<h2 class=\"wp-block-heading has-text-color has-link-color wp-elements-3\" style=\"color: #256820;\"><em>Master File for Devices now available<\/em><\/h2>\r\n For the manufacturer \u2018s medical devices registrations purposes, the SuperExpanite Master File for Devices is now available for reference and review at FDA. Expanite shall provide MAF Authorization letter on customer requests to make Expanite technical documentation available for FDA\u2019s review in context of their product registration.\r\n\r\n Please contact Thomas Abel Sandholdt to hear more about the FDA Master File for Devices, SuperExpanite MAF content and request a signed and named Authorization letter for your product registrations.\r\n\r\n \r\n<h2 class=\"wp-block-heading has-text-color has-link-color wp-elements-4\" style=\"color: #256820;\"><em>About Expanite<\/em><\/h2>\r\n \r\n<p class=\"has-text-color has-link-color wp-elements-5 wp-block-paragraph\" style=\"color: #256820;\"><em>Expanite offers state-of-the-art solutions for surface hardening treatment of stainless steels and titanium.\r\nWith Expanite&#8217;s processes, it is possible to increase the material\u2019s surface hardness tenfold while at the\r\nsame time maintaining and even increasing its corrosion resistance. Expanite is a global organization with\r\na combined development and production facility near Copenhagen, Denmark, and hardening capacity in\r\nboth US, Germany, Korea and China. Expanite&#8217;s solutions are flexible and can be introduced directly into a\r\ncustomer\u2019s own production line as part of a licensing arrangement. Learn more on <a href=\"https:\/\/expanite.com\" data-type=\"link\" data-id=\"expanite.com\">www.expanite.com<\/a><\/em><\/p>\r\n \r\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\r\n\r\n\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/expanite.com\/wp-content\/uploads\/2025\/03\/Expanite_FDA_Compliant.pdf\"><strong>Download PDF<\/strong><\/a><\/div>\r\n\r\n\r\n<\/div>\r\n &nbsp;\r\n\r\n","protected":false},"excerpt":{"rendered":"<p>Expanite\u00ae receives Master File for Devices (MAF) acknowledgment letter from FDA on their patented process for surface hardening of stainless steel in medical devices applications. and solving some of their challenges with wear on the titanium parts in their racing car. Expanite announces it has submitted a Master File for Devices (MAF) to the United [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2124,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-1200","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press"],"_links":{"self":[{"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/posts\/1200","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/comments?post=1200"}],"version-history":[{"count":9,"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/posts\/1200\/revisions"}],"predecessor-version":[{"id":3879,"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/posts\/1200\/revisions\/3879"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/media\/2124"}],"wp:attachment":[{"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/media?parent=1200"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/categories?post=1200"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/expanite.com\/it\/wp-json\/wp\/v2\/tags?post=1200"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}