{"id":258891,"date":"2021-12-07T09:14:38","date_gmt":"2021-12-07T08:14:38","guid":{"rendered":"https:\/\/www2.vbm-medical.de\/company\/quality-management\/"},"modified":"2022-03-09T14:39:34","modified_gmt":"2022-03-09T13:39:34","slug":"quality-management","status":"publish","type":"page","link":"https:\/\/www.vbm-medical.de\/en\/company\/quality-management\/","title":{"rendered":"Quality Management"},"content":{"rendered":"

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Quality Management<\/span><\/h1>\n

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Our Quality Management System is certified according to DIN EN ISO 13485 and MDSAP (requirements of the regulatory authorities Australia TGA, Brasilia ANVISA, Health Canada, USA FDA, Japan MHLW\/PMDA).<\/p>\n

The focal point of our Quality Management System is the high quality requirement regarding the performance and safety of our products and the satisfaction of our customers.<\/p>\n

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Scope of VBM Quality Management System<\/h3>\n

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    \n
  • ISO 13485:2016<\/li>\n
  • Medical Device Regulation (EU) 2017\/745<\/li>\n
  • USA: 21 CFR Part 820 \u2013 Quality System Regulation<\/li>\n
  • Canada: Medical Device Regulations<\/li>\n
  • Brazil: ANVISA \u2013 Good Manufacturing Practices<\/li>\n
  • Australia: Therapeutic Goods Regulations<\/li>\n
  • Japan: MHLW, PMD Act<\/li>\n
  • Korea: Good Manufacturing Practices<\/li>\n
  • Taiwan: Good Manufacturing Practices<\/li>\n
  • Medical Device Directive 93\/42\/EEC<\/li>\n<\/ul>\n

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    WEB001_PID-00-02-02_1.0_EN<\/p>\n

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    Quality ManagementOur Quality Management System is certified according to DIN EN ISO 13485 and MDSAP (requirements of the regulatory authorities Australia TGA, Brasilia ANVISA, Health Canada, USA FDA, Japan MHLW\/PMDA). The focal point of our Quality Management System is the high quality requirement regarding the performance and safety of our products and the satisfaction of […]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":258779,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"tags":[],"class_list":["post-258891","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages\/258891","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/comments?post=258891"}],"version-history":[{"count":26,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages\/258891\/revisions"}],"predecessor-version":[{"id":266169,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages\/258891\/revisions\/266169"}],"up":[{"embeddable":true,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages\/258779"}],"wp:attachment":[{"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/media?parent=258891"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/tags?post=258891"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}