{"id":52,"date":"2017-03-31T20:12:35","date_gmt":"2017-03-31T20:12:35","guid":{"rendered":"http:\/\/austmanufacturing.com\/development\/?page_id=52"},"modified":"2017-11-11T19:46:44","modified_gmt":"2017-11-11T19:46:44","slug":"regulatory-clinical-support","status":"publish","type":"page","link":"https:\/\/austmanufacturing.com\/development\/regulatory-clinical-support\/","title":{"rendered":"Regulatory &amp; Clinical Support"},"content":{"rendered":"<div id=\"pl-52\"  class=\"panel-layout\" ><div id=\"pg-52-0\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-52-0-0\"  class=\"panel-grid-cell panel-grid-cell-mobile-last\" ><div id=\"panel-52-0-0-0\" class=\"so-panel widget widget_text panel-first-child panel-last-child\" data-index=\"0\" >\t\t\t<div class=\"textwidget\"><p>AuST provides strategic regulatory, clinical, and quality support throughout the product development process.<\/p>\n\nRegulatory services include: \n<ul>\n<li>Global regulatory strategy development<\/li>\n<li>FDA meeting preparation and attendance<\/li>\n<li>Preparation of regulatory submissions for medical devices, including Pre-Submissions, IDEs, 510(k)s, PMAs, de novo applications, HDEs, 513(g) and Request for Designation<\/li>\n<li>OUS regulatory filings, including technical files and design dossier compilation and Health Canada License applications<\/li>\n<li>Labeling and marketing material review<\/li><\/ul>\n\nClinical services include:\n<ul>\n<li> Clinical Strategy Development<\/li>\n<li>Clinical Protocol Development<\/li>\n<li>Investigator Brochure Development<\/li>\n<li>Clinical Procedure On-Site Support<\/li>\n<\/ul>\nQuality services include:\n<ul>\n<li>Quality System development and implementation<\/li>\n<li>Training on regulatory and quality processes<\/li>\n<li>FDA inspection preparation (QSIT &amp; BIMO)<\/li>\n<li>Post-market support<\/li>\n<\/ul><\/div>\n\t\t<\/div><\/div><div id=\"pgc-52-0-1\"  class=\"panel-grid-cell panel-grid-cell-empty\" ><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>AuST provides strategic regulatory, clinical, and quality support throughout the product development process. Regulatory services include: Global regulatory strategy development FDA meeting preparation and attendance Preparation of regulatory submissions for medical devices, including Pre-Submissions, IDEs, 510(k)s, PMAs, de novo applications, HDEs, 513(g) and Request for Designation OUS regulatory filings, including technical files and design dossier [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-52","page","type-page","status-publish","hentry","post"],"_links":{"self":[{"href":"https:\/\/austmanufacturing.com\/development\/wp-json\/wp\/v2\/pages\/52","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/austmanufacturing.com\/development\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/austmanufacturing.com\/development\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/austmanufacturing.com\/development\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/austmanufacturing.com\/development\/wp-json\/wp\/v2\/comments?post=52"}],"version-history":[{"count":9,"href":"https:\/\/austmanufacturing.com\/development\/wp-json\/wp\/v2\/pages\/52\/revisions"}],"predecessor-version":[{"id":80,"href":"https:\/\/austmanufacturing.com\/development\/wp-json\/wp\/v2\/pages\/52\/revisions\/80"}],"wp:attachment":[{"href":"https:\/\/austmanufacturing.com\/development\/wp-json\/wp\/v2\/media?parent=52"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}