{"id":57,"date":"2019-01-29T09:56:58","date_gmt":"2019-01-29T09:56:58","guid":{"rendered":"https:\/\/www.garza.nu\/?page_id=57"},"modified":"2019-02-05T13:57:54","modified_gmt":"2019-02-05T13:57:54","slug":"regulation-and-standards","status":"publish","type":"page","link":"https:\/\/www.garza.nu\/?page_id=57","title":{"rendered":"Regulation and standards"},"content":{"rendered":"\n<p> Garza MD has extensive knowledge of and experience with the following regulation and standards:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>MDD 93\/42\/EEC (Medical Device Directive)<\/li><li>MDR 2017\/745 (Medical Device Regulation)<\/li><li>CMDR SOR\/98-282 (Canadian Medical Device Regulation)<\/li><li>FMD 2011\/62\/EU (Falsified Medicine Directive)<\/li><li>GDPR 2016\/679 (General Data Protection Regulation)<\/li><li>TGMDR 2002 (Australian Therapeutic Goods Regulations)<\/li><\/ul>\n\n\n\n<p><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>ISO 13485 \u2013 Quality Management Systems<\/li><li>ISO 9001 \u2013 Quality Management Systems<\/li><li>ISO 14971 \u2013 Risk Management<\/li><li>IEC 62366 \u2013 Usability<\/li><li>ISO 62304 \u2013 Medical Device Software Life Cycle<\/li><li>GAMP 5 \u2013 Risk based computer systems validation<\/li><li>IEC 60601-1 \u2013 Electrical Safety of Medical Equipment<\/li><li>ISO 27001 \u2013 Information Security Management Systems<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Garza MD has extensive knowledge of and experience with the following regulation and standards: MDD 93\/42\/EEC (Medical Device Directive) MDR 2017\/745 (Medical Device Regulation) CMDR SOR\/98-282 (Canadian Medical Device Regulation) FMD 2011\/62\/EU (Falsified Medicine Directive) GDPR 2016\/679 (General Data Protection Regulation) TGMDR 2002 (Australian Therapeutic Goods Regulations) ISO 13485 \u2013 Quality Management Systems ISO 9001 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"full-width.php","meta":{"footnotes":""},"class_list":["post-57","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3 - 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