{"id":99,"date":"2021-03-24T09:42:12","date_gmt":"2021-03-24T08:42:12","guid":{"rendered":"http:\/\/www.meliora-compliance.com\/?page_id=99"},"modified":"2023-09-20T21:12:56","modified_gmt":"2023-09-20T19:12:56","slug":"eu-ce-marking","status":"publish","type":"page","link":"https:\/\/www.meliora-compliance.com\/czech\/eu-ce-marking\/","title":{"rendered":"CE zna\u010dka - schv\u00e1len\u00ed pro EU"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"99\" class=\"elementor elementor-99\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-39f74d55 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"39f74d55\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;triangle&quot;,&quot;shape_divider_bottom_negative&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" data-negative=\"true\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 1000 100\" preserveaspectratio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M500.2,94.7L0,0v100h1000V0L500.2,94.7z\"\/>\n<\/svg>\t\t<\/div>\n\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-50 elementor-top-column elementor-element elementor-element-3184d8e6\" data-id=\"3184d8e6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7889bd59 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget elementor-widget-image\" data-id=\"7889bd59\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/CE-300x300.png\" class=\"elementor-animation-push attachment-medium size-medium wp-image-1310\" alt=\"\" srcset=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/CE-300x300.png 300w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/CE-150x150.png 150w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/CE-12x12.png 12w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/CE.png 512w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-754d4785\" data-id=\"754d4785\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-128fdb41 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"128fdb41\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">CE zna\u010dka - schv\u00e1len\u00ed pro EU<\/h1>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2cc3fc02 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2cc3fc02\" data-element_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-533ce471\" data-id=\"533ce471\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-33045cc0 elementor-widget elementor-widget-heading\" data-id=\"33045cc0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Na\u0161e CE slu\u017eby<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7555f621 elementor-widget elementor-widget-text-editor\" data-id=\"7555f621\" data-element_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<p><span style=\"font-weight: 400;\">Meliora Compliance v\u00e1m pom\u016f\u017ee z\u00edskat ozna\u010den\u00ed CE pro v\u00e1\u0161 prost\u0159edek v souladu s Na\u0159\u00edzen\u00edm o zdravotnick\u00fdch prost\u0159edc\u00edch (MDR 2017\/745).<\/span><\/p><p>Nab\u00edz\u00edme v\u00e1m proveden\u00ed n\u00e1sleduj\u00edc\u00edch \u00fakon\u016f:<\/p>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-230e8988 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"230e8988\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-4e48f7fb\" data-id=\"4e48f7fb\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1a32ba36 elementor-widget elementor-widget-text-editor\" data-id=\"1a32ba36\" data-element_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<ul><li aria-level=\"1\">Pomoc s vytvo\u0159en\u00edm va\u0161eho regulatorn\u00edho pl\u00e1nu k dosa\u017een\u00ed CE zna\u010dky<\/li><li aria-level=\"1\">V\u00fdb\u011br a nasmlouv\u00e1n\u00ed ozn\u00e1men\u00e9ho subjektu (NB), nebo p\u0159\u00edmo vlastn\u00ed v\u00fdkon funkce hlavn\u00edho kontaktu pro v\u00e1\u0161 NB<\/li><li aria-level=\"1\">V\u00fdb\u011br a nasmlouv\u00e1n\u00ed osoby odpov\u011bdn\u00e9 za dodr\u017eov\u00e1n\u00ed pr\u00e1vn\u00edch p\u0159edpis\u016f (PRRC) podle \u010cl\u00e1nku 15 Na\u0159\u00edzen\u00ed EU MDR, nebo p\u0159\u00edmo vlastn\u00ed v\u00fdkon funkce PRRC v p\u0159\u00edpad\u011b, \u017ee jste mikropodnik nebo mal\u00fd podnik\u00a0<\/li><li aria-level=\"1\">Ur\u010den\u00ed t\u0159\u00eddy va\u0161eho prost\u0159edku podle \u010cl\u00e1nku 51 Na\u0159\u00edzen\u00ed EU MDR<\/li><li aria-level=\"1\">Podpora va\u0161ich aktivit v oblasti \u0159\u00edzen\u00ed rizik v souladu s normou ISO 14971<\/li><li aria-level=\"1\">Pomoc p\u0159i tvorb\u011b va\u0161\u00ed zpr\u00e1vy o klinick\u00e9m hodnocen\u00ed (CER) podle MEDDEV 2.7 \/ 1 a va\u0161\u00ed celkov\u00e9 klinick\u00e9 strategie pro z\u00edsk\u00e1n\u00ed CE zna\u010dky<\/li><li aria-level=\"1\">Implementace nebo vylep\u0161en\u00ed va\u0161eho syst\u00e9mu \u0159\u00edzen\u00ed kvality, nejl\u00e9pe v souladu s ISO 13485<\/li><li aria-level=\"1\">B\u00fdt va\u0161\u00edm hlavn\u00edm kontaktem pro audity va\u0161eho ozn\u00e1men\u00e9ho\/ certifika\u010dn\u00edho org\u00e1nu<\/li><li aria-level=\"1\">Spolupr\u00e1ce s va\u0161\u00edm v\u00fdvojov\u00fdm t\u00fdmem na zaji\u0161t\u011bn\u00ed toho, aby v\u00fdvojov\u00e9 \u010dinnosti, v\u010detn\u011b testov\u00e1n\u00ed n\u00e1vrhu, byly prov\u00e1d\u011bny v souladu s harmonizovan\u00fdmi normami EU a dal\u0161\u00edmi platn\u00fdmi po\u017eadavky.<\/li><li aria-level=\"1\">Regulatorn\u00ed podpora va\u0161im klinick\u00fdm zkou\u0161k\u00e1m, kter\u00e9 budou slou\u017eit ke shrom\u00e1\u017ed\u011bn\u00ed dostate\u010dn\u00fdch klinick\u00fdch dat pro z\u00edsk\u00e1n\u00ed ozna\u010den\u00ed CE.<\/li><li aria-level=\"1\">Pl\u00e1n \u010dinnost\u00ed po uveden\u00ed na trh (PMS)<\/li><li aria-level=\"1\">Revize st\u00e1vaj\u00edc\u00ed technick\u00e9 dokumentace pro v\u00e1\u0161 v\u00fdrobek, nebo jej\u00ed vytvo\u0159en\u00ed v souladu s P\u0159\u00edlohou II Na\u0159\u00edzen\u00ed MDR EU<\/li><li aria-level=\"1\">Revize n\u00e1vodu k pou\u017eit\u00ed, revize ozna\u010den\u00ed na v\u00fdrobku (\u0161t\u00edtk\u016f) a marketingov\u00e9 dokumentace, aby byla zaji\u0161t\u011bna shoda s platn\u00fdmi regulatorn\u00edmi po\u017eadavky<\/li><li aria-level=\"1\">P\u0159ed\u00e1n\u00ed technick\u00e9 dokumentace va\u0161emu ozn\u00e1men\u00e9mu subjektu (NB) va\u0161\u00edm jm\u00e9nem a jej\u00ed obhajoba a\u017e do \u00fasp\u011b\u0161n\u00e9ho z\u00edsk\u00e1n\u00ed CE zna\u010dky<\/li><li aria-level=\"1\">Spolupr\u00e1ce s va\u0161imi hospod\u00e1\u0159sk\u00fdmi subjekty, v\u010detn\u011b v\u00fdb\u011bru a jmenov\u00e1n\u00ed va\u0161eho zplnomocn\u011bn\u00e9ho z\u00e1stupce pro EU, kter\u00fd bude jednat va\u0161\u00edm jm\u00e9nem, pokud nem\u00e1 va\u0161e firma s\u00eddlo v EU<\/li><li aria-level=\"1\">Podpora \u010dinnost\u00ed v oblasti sledov\u00e1n\u00ed po uveden\u00ed na trh (audity ISO a EU MDR prov\u00e1d\u011bn\u00e9 va\u0161\u00edm certifika\u010dn\u00edm \/ ozn\u00e1men\u00fdm subjektem, \u00fadr\u017eba QMS, \u00fadr\u017eba technick\u00e9 dokumentace, ozn\u00e1men\u00ed o zm\u011bn\u00e1ch va\u0161emu NB, PMS zpr\u00e1va, vigilance, PSUR, SSCP, PMCF atd.)<\/li><\/ul>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7dca5c43 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7dca5c43\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-44fe7394\" data-id=\"44fe7394\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1750c06f elementor-widget elementor-widget-heading\" data-id=\"1750c06f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-medium\">Dotazy?<br>\nNapi\u0161te n\u00e1m!<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1be6b519 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"1be6b519\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.meliora-compliance.com\/czech\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-right\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-long-arrow-alt-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Kontakt<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>EU CE marking\u200b Our CE marking services Meliora Compliance will help you to obtain CE mark for your device in compliance with the Medical Device Regulation (MDR 2017\/745).\u00a0This applies to the transfer of your legacy CE devices, as well as to newly designed products. We offer to perform the following tasks: Help to create your &#8230; <a title=\"CE zna\u010dka - schv\u00e1len\u00ed pro EU\" class=\"read-more\" href=\"https:\/\/www.meliora-compliance.com\/czech\/eu-ce-marking\/\" aria-label=\"V\u00edce na EU CE marking\">\u010c\u00edst d\u00e1l<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-99","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/99","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/comments?post=99"}],"version-history":[{"count":47,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/99\/revisions"}],"predecessor-version":[{"id":1429,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/99\/revisions\/1429"}],"wp:attachment":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/media?parent=99"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}