{"id":103,"date":"2021-03-24T09:42:42","date_gmt":"2021-03-24T08:42:42","guid":{"rendered":"http:\/\/www.meliora-compliance.com\/?page_id=103"},"modified":"2023-09-20T21:12:29","modified_gmt":"2023-09-20T19:12:29","slug":"regulatory-strategy","status":"publish","type":"page","link":"https:\/\/www.meliora-compliance.com\/czech\/regulatory-strategy\/","title":{"rendered":"Regulatorn\u00ed strategie"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"103\" class=\"elementor elementor-103\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-038bc18 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"038bc18\" 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-3ca1021\" data-id=\"3ca1021\" 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-144ad02c elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-image\" data-id=\"144ad02c\" 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\/08\/01_REGULATORNI-STRATEGIE-300x300.png\" class=\"elementor-animation-push attachment-medium size-medium wp-image-831\" alt=\"\" srcset=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/01_REGULATORNI-STRATEGIE-300x300.png 300w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/01_REGULATORNI-STRATEGIE-150x150.png 150w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/01_REGULATORNI-STRATEGIE-12x12.png 12w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/01_REGULATORNI-STRATEGIE.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-20c475d\" data-id=\"20c475d\" 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-22582380 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"22582380\" 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 translation-block\">Regulatorn\u00ed strategie<\/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-379c371 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"379c371\" 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-18ba38d\" data-id=\"18ba38d\" 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-68abba46 elementor-widget elementor-widget-heading\" data-id=\"68abba46\" 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 m\u00edt strategii?<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b382692 elementor-widget elementor-widget-text-editor\" data-id=\"b382692\" 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;\">Zohledn\u011bn\u00ed regulatorn\u00edch po\u017eadavk\u016f je velmi d\u016fle\u017eit\u00e9 pro ka\u017edou firmu, kter\u00e1 m\u00e1 v \u00famyslu navrhnout, vyvinout a prod\u00e1vat zdravotnick\u00fd prost\u0159edek.<\/span><\/p><p><span style=\"font-weight: 400;\">P\u0159i navrhov\u00e1n\u00ed nov\u00e9ho prost\u0159edku by m\u011bla b\u00fdt regulatorn\u00ed strategie vytvo\u0159ena ji\u017e v ran\u00e9 f\u00e1zi procesu n\u00e1vrhu a v\u00fdvoje.<\/span><\/p><p><span style=\"font-weight: 400;\">P\u0159i vytv\u00e1\u0159en\u00ed marketingov\u00e9 strategie pro zdravotnick\u00fd prost\u0159edek je t\u0159eba m\u00edt na pam\u011bti slo\u017eitost regulatorn\u00edch po\u017eadavk\u016f, lh\u016fty pro regulatorn\u00ed povolen\u00ed a schv\u00e1len\u00ed, dostupnost regulatorn\u00edch org\u00e1n\u016f a n\u00e1klady spojen\u00e9 s ragulatorn\u00edmi aktivitami.<\/span><\/p><p><span style=\"font-weight: 400;\">Meliora Compliance v\u00e1m pom\u016f\u017ee vytvo\u0159it regula\u010dn\u00ed strategii pro v\u00e1\u0161 prost\u0159edek, p\u0159i\u010dem\u017e zohledn\u00ed n\u00e1sleduj\u00edc\u00ed aspekty:<\/span><\/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-e6bb3a1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e6bb3a1\" 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-261a247\" data-id=\"261a247\" 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-331cded elementor-widget elementor-widget-text-editor\" data-id=\"331cded\" 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>Ur\u010den\u00ed, zda je v\u00e1\u0161 produkt zdravotnick\u00fdm prost\u0159edkem \u010di nikoli<\/li><li>Budouc\u00ed vlastnictv\u00ed regulatorn\u00edch schv\u00e1len\u00ed (kdo bude v\u00fdrobcem)<\/li><li>Zapojen\u00ed dal\u0161\u00edch hospod\u00e1\u0159sk\u00fdch subjekt\u016f (distributo\u0159i, zplnomocn\u011bn\u00ed z\u00e1stupci, dovozci)<\/li><li>Aktu\u00e1ln\u00ed regulatorn\u00ed status (ji\u017e he v\u00fdrobek na trhu v n\u011bkter\u00fdch zem\u00edch?)<\/li><li>C\u00edlov\u00e9 trhy a stanoven\u00ed priorit (EU, USA, ob\u011b, dal\u0161\u00ed zem\u011b)<\/li><li>Po\u017eadovan\u00e9 term\u00edny uveden\u00ed na trh<\/li><li>Slo\u017eitost regulatorn\u00edch po\u017eadavk\u016f na c\u00edlov\u00fdch trz\u00edch<\/li><li>U\u010den\u00e9 pou\u017eit\u00ed va\u0161eho prost\u0159edku (intended use)<\/li><li>Klasifikace prost\u0159edku<\/li><li>Aktu\u00e1ln\u00ed f\u00e1ze \u017eivotn\u00edho cyklu prost\u0159edku<\/li><li>Dostupnost a kvalifikace specialist\u016f pro regulatorn\u00ed \u010dinnost<\/li><li>N\u00e1klady na regulatorn\u00ed \u010dinnosti, jak intern\u00ed tak i t\u0159et\u00edch stran<\/li><li>Dostupn\u00e1 a pl\u00e1novan\u00e1 klinick\u00e1 data k v\u00fdrobku<\/li><li>Podobnost s jin\u00fdmi prost\u0159edky ji\u017e na trhu<\/li><li>Stav syst\u00e9mu \u0159\u00edzen\u00ed kvality<\/li><li>Schopnost vykon\u00e1vat \u010dinnosti spojen\u00e9 se sledov\u00e1n\u00edm po uveden\u00ed na trh<\/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-7eb5ca8c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7eb5ca8c\" 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-ad84444\" data-id=\"ad84444\" 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-10402c1c elementor-widget elementor-widget-heading\" data-id=\"10402c1c\" 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-39fba85a elementor-align-center elementor-widget elementor-widget-button\" data-id=\"39fba85a\" 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>Regulatorystrategy Why Strategy? Considering regulatory requirements is very important for any company who intends to design, develop and sell a medical device. When a new device is being designed, the regulatory strategy should be created in the early phase of the design and development process. The complexity of regulatory requirements, timelines for regulatory clearances and &#8230; <a title=\"Regulatorn\u00ed strategie\" class=\"read-more\" href=\"https:\/\/www.meliora-compliance.com\/czech\/regulatory-strategy\/\" aria-label=\"V\u00edce na Regulatory strategy\">\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-103","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/103","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=103"}],"version-history":[{"count":59,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/103\/revisions"}],"predecessor-version":[{"id":1426,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/103\/revisions\/1426"}],"wp:attachment":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/media?parent=103"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}