{"id":442,"date":"2018-10-13T02:01:45","date_gmt":"2018-10-13T00:01:45","guid":{"rendered":"http:\/\/localhost\/iAuditor%20web%20page\/?page_id=9"},"modified":"2019-02-04T20:16:35","modified_gmt":"2019-02-04T19:16:35","slug":"offer","status":"publish","type":"page","link":"https:\/\/iauditor.pl\/index.php\/en\/offer\/","title":{"rendered":"Offer"},"content":{"rendered":"<p style=\"font-style: normal; font-variant-caps: normal; margin-bottom: 0px; padding: 10px; outline: 0px; caret-color: #5b5b5b; color: #5b5b5b; font-family: 'Lucida Grande', Geneva, Verdana, Arial, Helvetica, sans-serif; font-size: 11px; text-align: left;\"><em style=\"outline: 0px; color: #c0c0c0; font-family: Arial, sans-serif; font-size: 14px;\">IAud<strong style=\"outline: 0px;\">itor Services:<\/strong>\u00a0<\/em><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px; text-align: justify;\"><em>European Union, USA, Canada legal assistance for medical devices, legal regulations MDD, MDR, MDSAP, documentation preparation, completion, approval\/clarifications\/registration (CE mark, 510 (k), MDSAP)<\/em><\/li>\n<li><em>Verification of technical documentation for compliance with requirements MDD and MDR (Medical Device Regulation 2017\/745)<\/em><\/li>\n<li><em>Establish\u00a0and implementation of quality management systems for notified bodies (procedures, forms, accreditation rules)<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px;\"><em>Establish and implementation of quality management systems for medical devices manufacturers according to EN 13485 (ISO 9001), MDD (93\/42\/EEC) and MDR (2017\/745) (Validation of software design process EN 62304, validation of ethylene oxide\u00a0sterilisation\u00a0processes EN 11135-1, validation of\u00a0<span style=\"outline: 0px;\">radiation\u00a0<\/span>sterilisation\u00a0process EN 11137-1).<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px;\"><em>European Representative for companies from outside the European Union.<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px;\"><em>Subcontracting as external Lead Auditor for medical device certification bodies\u00a0(after fulfilling the procedure of independence)<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px;\"><em>Identification and interpretation of documents containing guidelines for medical devices (MDD directive, MDR regulation, MedDev-s, NBOG-S, IAF-s)<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px;\"><em>Identifying and interpreting medical device standards<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px;\"><em>Detailed classification of medical devices, borderline devices.<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px;\"><em>A comprehensive training programme for manufacturers of medical devices.<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px;\"><em>Service questions and answers for problems related to medical devices.\u00a0<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"outline: 0px;\"><em>Internal and external audits of quality management systems (other parties) in accordance with the requirements of ISO 9001, EN 13485 and MDD (technical documentation reviews).<\/em><\/li>\n<li><em>Representation of the client before competent authorities.<\/em><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p lang=\"en-US\" style=\"font-style: normal; font-variant-caps: normal; margin-bottom: 0px; padding: 10px; outline: 0px; caret-color: #5b5b5b; color: #5b5b5b; font-family: 'Lucida Grande', Geneva, Verdana, Arial, Helvetica, sans-serif; font-size: 11px; text-align: justify;\"><em style=\"outline: 0px;\">(We speak Polish, English and Russian)<br style=\"margin: 0px; padding: 0px; outline: 0px;\" \/><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>IAuditor Services:\u00a0 European Union, USA, Canada legal assistance for medical devices, legal regulations MDD, MDR, MDSAP, documentation preparation, completion, approval\/clarifications\/registration (CE mark, 510 (k), MDSAP) Verification of technical documentation for compliance with requirements MDD and MDR (Medical Device Regulation 2017\/745) Establish\u00a0and implementation of quality management systems for notified bodies (procedures, forms, accreditation rules) Establish and&#8230; <\/p>\n<div class=\"read-more navbutton\"><a href=\"https:\/\/iauditor.pl\/index.php\/en\/offer\/\">Read More<i class=\"fa fa-angle-double-right\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-442","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/iauditor.pl\/index.php\/wp-json\/wp\/v2\/pages\/442","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/iauditor.pl\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/iauditor.pl\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/iauditor.pl\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/iauditor.pl\/index.php\/wp-json\/wp\/v2\/comments?post=442"}],"version-history":[{"count":4,"href":"https:\/\/iauditor.pl\/index.php\/wp-json\/wp\/v2\/pages\/442\/revisions"}],"predecessor-version":[{"id":643,"href":"https:\/\/iauditor.pl\/index.php\/wp-json\/wp\/v2\/pages\/442\/revisions\/643"}],"wp:attachment":[{"href":"https:\/\/iauditor.pl\/index.php\/wp-json\/wp\/v2\/media?parent=442"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}