{"id":105,"date":"2021-03-24T09:42:56","date_gmt":"2021-03-24T08:42:56","guid":{"rendered":"http:\/\/www.meliora-compliance.com\/?page_id=105"},"modified":"2023-09-26T16:04:20","modified_gmt":"2023-09-26T14:04:20","slug":"regulatory-partner-for-design-and-development","status":"publish","type":"page","link":"https:\/\/www.meliora-compliance.com\/czech\/regulatory-partner-for-design-and-development\/","title":{"rendered":"Regulatorn\u00ed podpora v\u00fdvoje"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"105\" class=\"elementor elementor-105\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-65e14143 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"65e14143\" 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-30938661\" data-id=\"30938661\" 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-10eccdb4 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget elementor-widget-image\" data-id=\"10eccdb4\" 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\/03_DD-300x300.png\" class=\"elementor-animation-push attachment-medium size-medium wp-image-1495\" alt=\"\" srcset=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/03_DD-300x300.png 300w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/03_DD-150x150.png 150w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/03_DD-12x12.png 12w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/03_DD.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-516ec51e\" data-id=\"516ec51e\" 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-192d5806 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"192d5806\" 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\">Regulatorn\u00ed podpora v\u00fdvoje<\/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-2c6f3509 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2c6f3509\" 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-1f0b1cb8\" data-id=\"1f0b1cb8\" 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-59aa9561 elementor-widget elementor-widget-heading\" data-id=\"59aa9561\" 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\">Pro\u010d podpora v\u00fdvoje?<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9f0beb elementor-widget elementor-widget-text-editor\" data-id=\"d9f0beb\" 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;\">Cesta k z\u00edsk\u00e1n\u00ed regulatorn\u00edho schv\u00e1len\u00ed pro zdravotnick\u00fd prost\u0159edek je dlouh\u00e1. Av\u0161ak ji\u017e v ran\u00e9 f\u00e1zi p\u0159ed uveden\u00edm na trh, aktivity v oblasti \u0159\u00edzen\u00ed n\u00e1vrhu a v\u00fdvoje (design and development) mus\u00ed b\u00fdt v souladu s platn\u00fdmi regulatorn\u00edmi po\u017eadavky od sam\u00e9ho po\u010d\u00e1tku ka\u017ed\u00e9ho v\u00fdvojov\u00e9ho projektu.<\/span><\/p><p><span style=\"font-weight: 400;\">Spole\u010dnost Meliora Compliance proto nab\u00edz\u00ed, \u017ee bude pracovat jako v\u00e1\u0161 partner v oblasti regulatorn\u00ed podpory pro va\u0161e aktivity v oblasti \u0159\u00edzen\u00ed n\u00e1vrhu a v\u00fdvoje - od prvotn\u00edho konceptu, p\u0159es testov\u00e1n\u00ed a klinick\u00e9 zkou\u0161ky, a\u017e po schv\u00e1len\u00ed v\u00fdrobku a p\u0159esun n\u00e1vrhu a v\u00fdvoje (design transfer) do v\u00fdroby.<\/span><\/p><p>Nab\u00edz\u00edme tyto slu\u017eby:<\/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-33a7856c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"33a7856c\" 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-1fbb8d8f\" data-id=\"1fbb8d8f\" 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-7b1f68e6 elementor-widget elementor-widget-text-editor\" data-id=\"7b1f68e6\" 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\">Pom\u016f\u017eeme v\u00e1m p\u0159i vytv\u00e1\u0159en\u00ed va\u0161\u00ed klinick\u00e9 a regulatorn\u00ed strategie<\/li><li aria-level=\"1\">Budeme v\u00e1s podporovat p\u0159i vytvo\u0159en\u00ed modulu va\u0161eho QMS, kter\u00fd bude pokr\u00fdvat \u0159\u00edzen\u00ed n\u00e1vrhu a v\u00fdvoje, a p\u0159i vytv\u00e1\u0159en\u00ed va\u0161ich standardn\u00edch opera\u010dn\u00edch p\u0159edpis\u016f v souladu s ISO 13485 nebo US FDA 21 CFR 820<\/li><li aria-level=\"1\">Podpo\u0159\u00edme tvorbu pl\u00e1nu pro \u0159\u00edzen\u00ed n\u00e1vrhu a v\u00fdvoje va\u0161eho zdravotnick\u00e9ho prost\u0159edku<\/li><li aria-level=\"1\">Budeme v\u00e1s podporovat p\u0159i shroma\u017e\u010fov\u00e1n\u00ed vstup\u016f do procesu \u0159\u00edzen\u00ed n\u00e1vrhu a v\u00fdvoje, v\u010detn\u011b stanoven\u00ed ur\u010den\u00e9ho pou\u017eit\u00ed va\u0161eho prost\u0159edku (intended use)<\/li><li aria-level=\"1\">Ur\u010d\u00edme, kter\u00e9 harmonizovan\u00e9 \/ uznan\u00e9 mezin\u00e1rodn\u00ed normy a dal\u0161\u00ed podp\u016frn\u00e9 dokumenty se vztahuj\u00ed na v\u00fdvoj va\u0161eho prost\u0159edku<\/li><li aria-level=\"1\">Budeme se pod\u00edlet na vytvo\u0159en\u00ed souboru \u0159\u00edzen\u00ed rizik pro v\u00e1\u0161 v\u00fdrobek (Risk Management File) podle ISO 14971<\/li><li aria-level=\"1\">Pom\u016f\u017eeme p\u0159ipravit protokoly pro va\u0161e testy (verifikace a validace n\u00e1vrhu)<\/li><li aria-level=\"1\">Budeme v\u00e1s podporovat p\u0159i v\u00fdb\u011bru a kvalifikaci zku\u0161ebn\u00edch laborato\u0159\u00ed pro testov\u00e1n\u00ed va\u0161eho prost\u0159edku<\/li><li aria-level=\"1\">Budeme se \u00fa\u010dastnit sch\u016fzek hodnocen\u00ed stavu n\u00e1vrhu a v\u00fdvoje (design reviews)<\/li><li aria-level=\"1\">Nav\u00e1\u017eeme \u00favodn\u00ed komunikaci s va\u0161imi ozn\u00e1men\u00fdmi subjekty v EU, americk\u00fdm \u00fa\u0159adem FDA a dal\u0161\u00edmi regulatorn\u00edmi org\u00e1ny, v\u010detn\u011b pod\u00e1n\u00ed p\u0159edb\u011b\u017en\u00fdch \u017e\u00e1dost\u00ed (pre-submissions) americk\u00e9mu \u00fa\u0159adu FDA<\/li><li aria-level=\"1\">Poskytneme regulatorn\u00ed podporu k z\u00edsk\u00e1n\u00ed schv\u00e1len\u00ed va\u0161ich klinick\u00fdch studi\u00ed p\u0159ed uveden\u00edm na trh od etick\u00fdch komis\u00ed a p\u0159\u00edslu\u0161n\u00fdch n\u00e1rodn\u00edch \u00fa\u0159ad\u016f \/ americk\u00e9ho \u00fa\u0159adu FDA<\/li><li aria-level=\"1\">Budeme v\u00e1s podporovat p\u0159i vytv\u00e1\u0159en\u00ed a \u00fadr\u017eb\u011b va\u0161\u00ed slo\u017eky obsahuj\u00edc\u00ed dokumentaci k \u0159\u00edzen\u00ed n\u00e1vrhu a v\u00fdvoje pro v\u00e1\u0161 konkr\u00e9tn\u00ed v\u00fdrobek (DHF)<\/li><li aria-level=\"1\">Podpo\u0159\u00edme v\u00e1s ve va\u0161em zm\u011bnov\u00e9m \u0159\u00edzen\u00ed na v\u00fdrobku , a take ve va\u0161\u00ed \u010dinnosti souvisej\u00edc\u00edc\u00ed s p\u0159enosem n\u00e1vrhu a v\u00fdvoje do v\u00fdroby<\/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-3bb98358 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3bb98358\" 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-40d3e427\" data-id=\"40d3e427\" 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-189a76ab elementor-widget elementor-widget-heading\" data-id=\"189a76ab\" 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-1f0249ac elementor-align-center elementor-widget elementor-widget-button\" data-id=\"1f0249ac\" 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>Regulatory partner for design and development Why regulatory support? There is long way for a device to reach the regulatory approval. However, already in the early pre-market phase, the design and development activities must comply with applicable regulatory requirements from the very beginning. Therefore, Meliora Compliance offers to act as the regulatory partner for your &#8230; <a title=\"Regulatorn\u00ed podpora v\u00fdvoje\" class=\"read-more\" href=\"https:\/\/www.meliora-compliance.com\/czech\/regulatory-partner-for-design-and-development\/\" aria-label=\"V\u00edce na Regulatory partner for design and development\">\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-105","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/105","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=105"}],"version-history":[{"count":59,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/105\/revisions"}],"predecessor-version":[{"id":1501,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/105\/revisions\/1501"}],"wp:attachment":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/media?parent=105"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}