{"id":2029,"date":"2017-12-14T16:00:33","date_gmt":"2017-12-14T16:00:33","guid":{"rendered":"http:\/\/dconsulting.gr\/?page_id=2029"},"modified":"2017-12-19T16:11:02","modified_gmt":"2017-12-19T16:11:02","slug":"%cf%83%cf%85%ce%bc%ce%b2%ce%bf%cf%85%ce%bb%ce%b5%cf%85%cf%84%ce%b9%ce%ba%ce%ad%cf%82-%cf%85%cf%80%ce%b7%cf%81%ce%b5%cf%83%ce%af%ce%b5%cf%82-2-2-2-2-2-2","status":"publish","type":"page","link":"https:\/\/dconsulting.gr\/?page_id=2029&lang=en","title":{"rendered":"ISO 13485"},"content":{"rendered":"

[vc_row][vc_column width=”1\/4″][stm_sidebar sidebar=”2047″][\/vc_column][vc_column width=”3\/4″][vc_custom_heading text=”Engineering and development of quality management systems; products for medical use – systems for regulatory purposes (ISO 13485)” font_container=”tag:h3|text_align:left” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:400%20regular%3A400%3Anormal”][vc_custom_heading text=”Purpose” font_container=”tag:h4|text_align:left” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:400%20regular%3A400%3Anormal”][vc_column_text]Controlling and reducing errors and failures encountered by businesses producing medical\u00a0<\/span>devices daily requires the systematic management of processes, the adoption of appropriate\u00a0<\/span>measures and the certification\u00a0CE<\/span> of the products.<\/span>[\/vc_column_text][vc_custom_heading text=”Framework” font_container=”tag:h4|text_align:left” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:400%20regular%3A400%3Anormal”][vc_column_text]The European Norm, EN ISO 13485:2012 Medical Devices – Quality Management Systems –\u00a0<\/span>Requirements for Regulatory Purposes, issued after the approval of CEN on January, 24 th\u00a0<\/span>2012 and replaces the EN ISO 13485: 2003, although the basic text has not changed (only\u00a0<\/span>the prologue and some minor changes to the annexes). This was done to bring the standard\u00a0<\/span>into line with the framework and requirements for issuing the Certificate of Compliance\u00a0<\/span>(Annex 2 and Annex 5 of Directive 90\/385\/EEC AIMD; Annex II, V and VI of Directive\u00a0<\/span>93\/42\/EEC MDD; or Annex III, IV and VII of Directive 98\/79\/EC IVDD).<\/span>[\/vc_column_text][vc_custom_heading text=”Our services” font_container=”tag:h4|text_align:left” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:400%20regular%3A400%3Anormal”][vc_column_text]Having as a main objective the total customer satisfaction, we develop, maintain, improve\u00a0<\/span>and upgrade reliable systems and structures in companies that already have or do not have\u00a0<\/span>organized departments and management systems for medical products and devices (ISO\u00a0<\/span>13485).<\/span>
\nWe look for the issue of Technical File, the implementation of analysis tests related to the\u00a0<\/span>product.<\/span>[\/vc_column_text][vc_custom_heading text=”The system (ISO 13485)” font_container=”tag:h4|text_align:left” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:400%20regular%3A400%3Anormal”][vc_column_text]The International Organization for Standardization (ISO) has already replaced this version by\u00a0<\/span>ISO 13485: 2016 but given the three-year transition period that follows all standards, the\u00a0<\/span>new version becomes mandatory from March 2019 (since the new standard was issued in\u00a0<\/span>March 2016).<\/span>
\nThrough the implementation of the Quality Management System imposed by the standard,\u00a0<\/span>it is ensured that:<\/span>
\n\u2022<\/span> the legal and regulatory requirements related to the movement of products and\u00a0<\/span>their CE marking are applied, where appropriate<\/span>
\n\u2022<\/span> decisions are made on the basis of analysis and systematic measurements based\u00a0<\/span>on the process-based approach<\/span>
\n\u2022<\/span> the resources required for continuous improvement are provided and the\u00a0<\/span>application of these principles and procedures is reviewed by the company’s top\u00a0<\/span>management<\/span><\/p>\n

Contact us<\/a> for further information for any\u00a0<\/span>questions you may have or any clarifications you may need.<\/span>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

[vc_row][vc_column width=”1\/4″][stm_sidebar sidebar=”2047″][\/vc_column][vc_column width=”3\/4″][vc_custom_heading text=”Engineering and development of quality management systems; products for medical use – systems for regulatory purposes (ISO 13485)” font_container=”tag:h3|text_align:left” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:400%20regular%3A400%3Anormal”][vc_custom_heading text=”Purpose” font_container=”tag:h4|text_align:left” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:400%20regular%3A400%3Anormal”][vc_column_text]Controlling and reducing errors and failures encountered by businesses producing medical\u00a0devices daily requires the systematic management of processes, the adoption of appropriate\u00a0measures and the certification\u00a0CE of the products.[\/vc_column_text][vc_custom_heading text=”Framework”<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/dconsulting.gr\/index.php?rest_route=\/wp\/v2\/pages\/2029"}],"collection":[{"href":"https:\/\/dconsulting.gr\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dconsulting.gr\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dconsulting.gr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dconsulting.gr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2029"}],"version-history":[{"count":3,"href":"https:\/\/dconsulting.gr\/index.php?rest_route=\/wp\/v2\/pages\/2029\/revisions"}],"predecessor-version":[{"id":2119,"href":"https:\/\/dconsulting.gr\/index.php?rest_route=\/wp\/v2\/pages\/2029\/revisions\/2119"}],"wp:attachment":[{"href":"https:\/\/dconsulting.gr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2029"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}