{"id":214,"date":"2014-09-20T06:21:07","date_gmt":"2014-09-20T06:21:07","guid":{"rendered":"https:\/\/compliancems.com.au\/?p=214"},"modified":"2014-09-20T06:21:07","modified_gmt":"2014-09-20T06:21:07","slug":"australian-medical-device-conformity-assessments-tga","status":"publish","type":"post","link":"https:\/\/compliancems.com.au\/?p=214","title":{"rendered":"Australian Medical Device Conformity Assessments (TGA)"},"content":{"rendered":"

Currently, the\u00a0TGA is the only Notified Body in Australia that can issue Conformity Assessments (CA). There has been significant movement with respect to CA for Australian medical device manufacturers. It is expected that in 2015 the TGA will accept conformity assessments from 3rd party Notified Bodies.\u00a0<\/span><\/span><\/span>\u00a0<\/span><\/p>\n

If you require further information regarding this significant change or a CA quotation, please do not hesitate to contact Compliance Management Solutions.\u00a0<\/span>\u00a0<\/span><\/strong><\/p>\n

About CMS:<\/span><\/strong>\u00a0<\/span><\/p>\n

Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include:<\/span><\/span><\/span><\/p>\n

\u00a0<\/span>\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Australian ARTG registration\/sponsorship\/consultancy (medical devices\/medicinal products)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Implementation and maintenance of Management Systems (TGA\/MDD\/ISO 13485\/Sterilization\/ISO 9001)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Management Systems audits \u2013 (TGA\/MDD\/ISO 13485\/Sterilization\/ISO 9001)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 3rd Party Notified Body Certification Audits (MDD\/ISO 13485\/ISO 9001\/ISO 22716)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Quotations for ISO transfer of certificate<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Risk Management<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Continuous improvement including Corrective\/Preventive Action<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Validation including (Process\/Equipment Qualification\/Sterilization)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Machinery\/Equipment commissioning\/installation and troubleshooting<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Complaint handling<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Process Improvement using Lean Six Sigma methodologies<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Web based compliance management software<\/p>\n

\u00a0<\/span>Thank you and regards,<\/span><\/p>\n

\u00a0<\/span>George Loizou
\nCompliance Management Solutions<\/span><\/p>\n

\u00a0<\/span>E:\u00a0\u00a0<\/span>gloizou@compliancems.com.au<\/span><\/span><\/a>\u00a0| M: +61 4 3312 4266
\nW:\u00a0<\/span>https:\/\/compliancems.com.au<\/span><\/span><\/a><\/p>\n

\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Currently, the\u00a0TGA is the only Notified Body in Australia that can issue Conformity Assessments (CA). There has been significant movement with respect to CA for Australian medical device manufacturers. It is expected that in 2015 the TGA will accept conformity assessments from 3rd party Notified Bodies.\u00a0\u00a0 If you require further information regarding this significant change or a CA quotation, please do not hesitate to contact Compliance Management Solutions.\u00a0\u00a0 About CMS:\u00a0 Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include: \u00a0\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Australian ARTG registration\/sponsorship\/consultancy (medical devices\/medicinal products) \u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0[…]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-214","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/214","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=214"}],"version-history":[{"count":1,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/214\/revisions"}],"predecessor-version":[{"id":215,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/214\/revisions\/215"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=214"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=214"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=214"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}