{"id":9,"date":"2018-10-13T02:01:45","date_gmt":"2018-10-13T00:01:45","guid":{"rendered":"http:\/\/localhost\/iAuditor%20web%20page\/?page_id=9"},"modified":"2018-11-03T19:00:55","modified_gmt":"2018-11-03T18:00:55","slug":"oferta","status":"publish","type":"page","link":"https:\/\/iauditor.pl\/index.php\/oferta\/","title":{"rendered":"Oferta"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"9\" class=\"elementor elementor-9 elementor-bc-flex-widget\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7a6390e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7a6390e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f8a5714\" data-id=\"f8a5714\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e08de57 elementor-widget elementor-widget-text-editor\" data-id=\"e08de57\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<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;\">Us\u0142ugi<strong style=\"outline: 0px;\"> firmy iAuditor:\u00a0<\/strong><\/em><\/p><ul><li style=\"outline: 0px; text-align: justify;\"><span style=\"word-spacing: normal; color: #c0c0c0; font-size: 14px; text-indent: -1.1em; outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Unia Europejska, USA, Canada asysta prawna dla wyrob\u00f3w medycznych<\/strong><\/span><\/em><\/span><\/span><span style=\"word-spacing: normal; color: #c0c0c0; font-size: 14px; text-indent: -1.1em; outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">, Regulacje prawne MDD, MDR, MDSAP, Przygotowanie dokumentacji, Kompletacja,\u00a0<\/em><\/span><\/span><span style=\"word-spacing: normal; color: #c0c0c0; font-size: 14px; text-indent: -1.1em; outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Zatwierdzenie \/ Obja\u015bnienia \/ Rejestracja<\/strong><\/span><\/em><\/span><\/span><span style=\"word-spacing: normal; color: #c0c0c0; font-size: 14px; text-indent: -1.1em; outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0(znak CE, 510 (k), MDSAP)<\/em><\/span><\/span><\/li><li><span style=\"color: #c0c0c0; font-family: Arial, sans-serif;\"><span style=\"text-decoration: underline;\"><em><strong>Weryfikacja dokumentacji technicznej<\/strong><\/em><\/span>\u00a0<i>pod k\u0105tem zgodno\u015bci z wymagaiami MDD i MDR (Medical Device Regulation 2017\/745)<\/i><\/span><\/li><li><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">Ustanowienie i Wdro\u017cenie\u00a0<\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">System\u00f3w Zarz\u0105dzania Jako\u015bci\u0105<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0dla\u00a0<\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Jednostek notyfikowanych<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0(procedury, formularze, przepisy akredytacyjne)<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">Ustanowienie i Wdro\u017cenie\u00a0<\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">System\u00f3w Zarz\u0105dzania Jako\u015bci\u0105<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0dla\u00a0<\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Producent\u00f3w Wyrob\u00f3w Medycznych<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0zgodnie z norm\u0105 EN 13485 (EN 9001), MDD (93\/42\/EEC) i MDR (2017\/745) (ekspert ds. walidacji procesu tworzenia oprogramowania EN 62304, walidacja proces\u00f3w sterylizacji tlenkiem etylenu EN 11135-1, walidacja procesu sterylizacji radiacyjnej EN 11137-1).<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Przedstawiciel w Unii Europejskiej\u00a0<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">dla firm z poza Unii Europejskiej.<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Podwykonawstwo jako Zewn\u0119trzny Auditor Wiod\u0105cy<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0dla\u00a0<\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Jednostek Certyfikuj\u0105cych wyroby medyczne<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0(po spe\u0142nieniu procedury niezale\u017cno\u015b\u0107)<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Identyfikowanie i interpretacja dokument\u00f3w<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0zawieraj\u0105cych wytyczne dla wyrob\u00f3w medycznych (Dyrektywy &#8211; MDD, Rozporz\u0105dzenia &#8211; MDR, MedDev-y, NBOGS, IAF)<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Identyfikowanie i interpretacja Standard\u00f3w<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0Medycznych<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">Szczeg\u00f3\u0142owa\u00a0<\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">klasyfikacja<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0z interpretacj\u0105 dla Wyrob\u00f3w Medycznych<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">Szeroki\u00a0<\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">program szkole\u0144<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0dla producent\u00f3w wyrob\u00f3w medycznych.<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Serwis pytania i odpowiedzi<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0dla problem\u00f3w zwi\u0105zanych z wyrobami medycznymi.\u00a0<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Audity wewn\u0119trzne i zewn\u0119trzne\u00a0<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">(drugiej strony)<\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">\u00a0System\u00f3w Zarz\u0105dzania Jako\u015bci\u0105<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0zgodnie z wymaganiami EN 9001, EN 13485 i MDD (przegl\u0105dy dokumentacji technicznej).<\/em><\/span><\/span><\/span><\/li><li style=\"outline: 0px;\"><span style=\"outline: 0px; color: #c0c0c0; font-size: 14px;\"><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\"><span style=\"outline: 0px; text-decoration: underline;\"><strong style=\"outline: 0px;\">Reprezentacja klienta<\/strong><\/span><\/em><\/span><\/span><span style=\"outline: 0px; font-family: Arial, sans-serif;\"><span lang=\"en-US\" style=\"outline: 0px;\"><em style=\"outline: 0px;\">\u00a0przed organami kompetentnymi.<\/em><\/span><\/span><\/span><\/li><\/ul><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;\"><span style=\"outline: 0px; font-family: Arial, sans-serif; color: #c0c0c0; font-size: 14px;\"><em style=\"outline: 0px;\">(M\u00f3wimy po polsku, angielsku i rosyjsku)<br style=\"margin: 0px; padding: 0px; outline: 0px;\" \/><\/em><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Us\u0142ugi firmy iAuditor:\u00a0 Unia Europejska, USA, Canada asysta prawna dla wyrob\u00f3w medycznych, Regulacje prawne MDD, MDR, MDSAP, Przygotowanie dokumentacji, Kompletacja,\u00a0Zatwierdzenie \/ Obja\u015bnienia \/ Rejestracja\u00a0(znak CE, 510 (k), MDSAP) Weryfikacja dokumentacji technicznej\u00a0pod k\u0105tem zgodno\u015bci z wymagaiami MDD i MDR (Medical Device Regulation 2017\/745) Ustanowienie i Wdro\u017cenie\u00a0System\u00f3w Zarz\u0105dzania Jako\u015bci\u0105\u00a0dla\u00a0Jednostek notyfikowanych\u00a0(procedury, formularze, przepisy akredytacyjne) Ustanowienie i Wdro\u017cenie\u00a0System\u00f3w Zarz\u0105dzania&#8230; 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