{"id":134,"date":"2017-03-28T17:27:52","date_gmt":"2017-03-28T17:27:52","guid":{"rendered":"http:\/\/austmanufacturing.com\/?page_id=134"},"modified":"2017-03-28T17:27:52","modified_gmt":"2017-03-28T17:27:52","slug":"regulatory-and-quality-support","status":"publish","type":"page","link":"https:\/\/austmanufacturing.com\/wordpress\/regulatory-and-quality-support\/","title":{"rendered":"Regulatory and Quality Support"},"content":{"rendered":"<p>AuST provides strategic regulatory and quality system support to guide clients through the regulatory process.<\/p>\n<p>Services include:<br \/>\n\u2022 Global regulatory strategy development<br \/>\n\u2022 FDA meeting preparation and attendance<br \/>\n\u2022 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<br \/>\n\u2022 OUS regulatory filings, including technical files and design dossier compilation<br \/>\n\u2022 Labeling and marketing material review<br \/>\n\u2022 Quality System documentation development<br \/>\n\u2022 Training on regulatory and quality processes<br \/>\n\u2022 FDA inspection preparation (QSIT &amp; BIMO)<br \/>\n\u2022 Post-market support<\/p>\n","protected":false},"excerpt":{"rendered":"<p>AuST provides strategic regulatory and quality system support to guide clients through the regulatory process. Services include: \u2022 Global regulatory strategy development \u2022 FDA meeting preparation and attendance \u2022 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 \u2022 OUS regulatory filings, including [&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-134","page","type-page","status-publish","hentry","post"],"_links":{"self":[{"href":"https:\/\/austmanufacturing.com\/wordpress\/wp-json\/wp\/v2\/pages\/134","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/austmanufacturing.com\/wordpress\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/austmanufacturing.com\/wordpress\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/austmanufacturing.com\/wordpress\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/austmanufacturing.com\/wordpress\/wp-json\/wp\/v2\/comments?post=134"}],"version-history":[{"count":1,"href":"https:\/\/austmanufacturing.com\/wordpress\/wp-json\/wp\/v2\/pages\/134\/revisions"}],"predecessor-version":[{"id":135,"href":"https:\/\/austmanufacturing.com\/wordpress\/wp-json\/wp\/v2\/pages\/134\/revisions\/135"}],"wp:attachment":[{"href":"https:\/\/austmanufacturing.com\/wordpress\/wp-json\/wp\/v2\/media?parent=134"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}