{"id":525,"date":"2016-08-09T09:12:53","date_gmt":"2016-08-09T09:12:53","guid":{"rendered":"http:\/\/www.compumedics.com.au\/?page_id=525"},"modified":"2024-09-10T19:26:22","modified_gmt":"2024-09-10T08:26:22","slug":"regulatory-compliance","status":"publish","type":"page","link":"https:\/\/www.compumedics.com.au\/en\/about-compumedics\/regulatory-compliance\/","title":{"rendered":"Regulatory Compliance"},"content":{"rendered":"<p>Compumedics continues to instill a culture of quality within all processes and employees, which is reiterated by a globally recognized quality assurance system. The Company\u2019s rigorous quality assurance system addresses all medical and manufacturing regulatory requirements including:<\/p>\n<ul>\n<li>FDA (USA)<\/li>\n<li>CE Mark (Europe)<\/li>\n<li>TGA (Australia)<\/li>\n<li>IEC 60601- Medical device electrical safety standards<\/li>\n<li>ISO 27001 &#8211; Information security management systems<\/li>\n<li>ISO 13485 Quality Systems \u2013 Medical Devices<\/li>\n<li>Medical Device Single Audit Program (MDSAP) Quality management systems<\/li>\n<li>Good Manufacturing Practice (GMP)<\/li>\n<\/ul>\n<p>Compumedics works closely with regulatory approval authorities, including: Therapeutic Goods Administration in Australia (TGA), Food and Drug Administration in the USA (FDA), CE Mark in Europe; the Korean Food and Drug Administration, and Japanese regulatory approval bodies. Compumedics believes that all its products currently in the market and their manufacturing processes meet the requirements of the appropriate regulations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Compumedics continues to instill a culture of quality within all processes and employees, which is reiterated by a globally recognized quality assurance system. The Company\u2019s rigorous quality assurance system addresses all medical and manufacturing regulatory requirements including: FDA (USA) CE [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":78,"menu_order":55,"comment_status":"closed","ping_status":"closed","template":"page-about.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-525","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.compumedics.com.au\/en\/wp-json\/wp\/v2\/pages\/525","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.compumedics.com.au\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.compumedics.com.au\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.compumedics.com.au\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.compumedics.com.au\/en\/wp-json\/wp\/v2\/comments?post=525"}],"version-history":[{"count":0,"href":"https:\/\/www.compumedics.com.au\/en\/wp-json\/wp\/v2\/pages\/525\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.compumedics.com.au\/en\/wp-json\/wp\/v2\/pages\/78"}],"wp:attachment":[{"href":"https:\/\/www.compumedics.com.au\/en\/wp-json\/wp\/v2\/media?parent=525"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}