{"id":128468,"date":"2025-10-03T09:08:19","date_gmt":"2025-10-03T07:08:19","guid":{"rendered":"https:\/\/key2compliance.com\/?page_id=128468"},"modified":"2026-01-28T16:25:16","modified_gmt":"2026-01-28T15:25:16","slug":"kliniska-undersokningar-och-prestandastudier","status":"publish","type":"page","link":"https:\/\/key2compliance.com\/sv\/clinical-investigations-and-performance-studies\/","title":{"rendered":"Kliniska unders\u00f6kningar och prestandastudier"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"128468\" class=\"elementor elementor-128468\" data-elementor-post-type=\"page\">\n\t\t\t\t<main class=\"elementor-element elementor-element-3c91568 e-flex e-con-boxed e-con e-parent\" data-id=\"3c91568\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-159bad9 e-con-full e-flex e-con e-child\" data-id=\"159bad9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-98c8f69 e-con-full e-flex e-con e-child\" data-id=\"98c8f69\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1f113df elementor-widget elementor-widget-heading\" data-id=\"1f113df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Kliniska unders\u00f6kningar och prestandastudier<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dfd2ab6 elementor-widget elementor-widget-text-editor\" data-id=\"dfd2ab6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Kliniska pr\u00f6vningar f\u00f6r medicintekniska produkter och in vitro-diagnostik (IVD) f\u00f6ljer en strukturerad process, som vanligtvis \u00e4r uppdelad i tre nyckelfaser. Varje fas har specifika regulatoriska krav och leveranser, i enlighet med:<\/p><ul><li><b>ISO 14155 \u2013 Klinisk pr\u00f6vning av medicintekniska produkter f\u00f6r m\u00e4nniska \u2013 God klinisk sed<\/b>\u00a0<\/li><li><b>ISO 20916 \u2013 Medicintekniska produkter f\u00f6r in vitro-diagnostik \u2013 Kliniska prestandastudier med prover fr\u00e5n m\u00e4nniska \u2013 God sed f\u00f6r studier<\/b>.<\/li><\/ul><p>\u00d6versikten nedan beskriver vad varje fas innefattar \u2013 fr\u00e5n planering till slutf\u00f6rande.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-cb678cd e-con-full e-flex e-con e-child\" data-id=\"cb678cd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9a8c84c elementor-widget elementor-widget-image\" data-id=\"9a8c84c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/10\/clin-invperf-studies_860.avif\" class=\"attachment-large size-large wp-image-130576\" alt=\"Laboratorieassistent\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/10\/clin-invperf-studies_860.avif 860w, https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/10\/clin-invperf-studies_860-300x200.avif 300w, https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/10\/clin-invperf-studies_860-768x512.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/10\/clin-invperf-studies_860-600x400.avif 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/main>\n\t\t<main class=\"elementor-element elementor-element-027a232 e-flex e-con-boxed e-con e-parent\" data-id=\"027a232\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c2f914f elementor-widget elementor-widget-menu-anchor\" data-id=\"c2f914f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"studyphases\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-cd9d2f8 e-con-full e-flex e-con e-child\" data-id=\"cd9d2f8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-630d090 e-con-full e-flex e-con e-child\" data-id=\"630d090\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a767987 elementor-widget elementor-widget-heading\" data-id=\"a767987\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Fas 1 \u2013 F\u00f6rstudie<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4724e33 elementor-widget elementor-widget-text-editor\" data-id=\"4724e33\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"background-color: transparent;\"><b>Syfte:<\/b>\u00a0<br \/>L\u00e4gg den regulatoriska och operationella grunden<\/span><\/p><p><strong><span style=\"background-color: transparent;\">Inneh\u00e5ller:<\/span><\/strong><\/p><ul><li><span style=\"background-color: transparent;\">Studiedesign och endpoint-definition<\/span><\/li><li><span style=\"background-color: transparent;\">Biostatistik<\/span><\/li><li><span style=\"background-color: transparent;\">Klinisk datahantering<\/span><\/li><li><span style=\"background-color: transparent;\">Genomf\u00f6rbarhet och val av plats<\/span><\/li><li><span style=\"background-color: transparent;\">Utveckling av plan f\u00f6r klinisk pr\u00f6vning (CIP) \/ plan f\u00f6r klinisk prestandastudie (CPSP)<\/span><\/li><li><span style=\"background-color: transparent;\">Utveckling av plan f\u00f6r informerat samtycke<\/span><\/li><li><span style=\"background-color: transparent;\">Utarbetning och inl\u00e4mning av ans\u00f6kningshandlingar till etikpr\u00f6vningsmyndigheter och beh\u00f6riga myndigheter<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f9d737d e-con-full e-flex e-con e-child\" data-id=\"f9d737d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9e50e34 elementor-widget elementor-widget-heading\" data-id=\"9e50e34\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Fas 2 \u2013 Genomf\u00f6rande av studie<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-120023c elementor-widget elementor-widget-text-editor\" data-id=\"120023c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><b>Syfte:\u00a0<\/b><br \/>Utf\u00f6r studien i enlighet med CIP\/CPSP och god klinisk sed (GCP)<\/p><p><strong>Inneh\u00e5ller:<\/strong><\/p><ul><li>Platsinitiering och \u00f6vervakning<\/li><li>Kordination av klinisk datahantering<\/li><li>S\u00e4kerhetsstyrning och medicinsk \u00f6vervakning<\/li><li>eTMF-konfigurering och l\u00f6pande underh\u00e5ll<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-40983a3 e-con-full e-flex e-con e-child\" data-id=\"40983a3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d3cb483 elementor-widget elementor-widget-heading\" data-id=\"d3cb483\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Fas 3 \u2013 Avslutning av studie<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ac88ec9 elementor-widget elementor-widget-text-editor\" data-id=\"ac88ec9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>Syfte:\u00a0<\/strong><br \/>Slutf\u00f6r studiedokumentationen och s\u00e4kerst\u00e4ll efterlevnad<br \/><br \/><strong>Inneh\u00e5ller:<\/strong><\/p><ul><li>Databasl\u00e5s och samordning av dataanalys<\/li><li>Biostatistisk analys<\/li><li>Utveckling av klinisk utredningsrapport (CIR) \/ rapport om klinisk prestandastudie (CPSR)<\/li><li>eTMF-avst\u00e4mning och arkivering<\/li><li>Avslutningsbes\u00f6k och uppf\u00f6ljning fr\u00e5n myndigheter<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d9fa105 e-con-full e-flex e-con e-child\" data-id=\"d9fa105\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5a43c29 e-con-full e-flex e-con e-child\" data-id=\"5a43c29\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-44d9c92 elementor-widget elementor-widget-heading\" data-id=\"44d9c92\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">V\u00e4ssa dina kunskaper med v\u00e5ra kostnadsfria handledningar<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-01dd459 e-con-full e-flex e-con e-child\" data-id=\"01dd459\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d99aa98 e-con-full e-flex e-con e-child\" data-id=\"d99aa98\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8a08262 elementor-widget elementor-widget-image\" data-id=\"8a08262\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/vimeo.com\/1158358548\" target=\"_blank\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"768\" height=\"414\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/01\/tutorial-application-clinical-investigations-play-wide-768x414.avif\" class=\"attachment-medium_large size-medium_large wp-image-132151\" alt=\"Handledning \u2013 Ans\u00f6kan om kliniska pr\u00f6vningar\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/01\/tutorial-application-clinical-investigations-play-wide-768x414.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/01\/tutorial-application-clinical-investigations-play-wide-300x162.avif 300w, https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/01\/tutorial-application-clinical-investigations-play-wide-600x324.avif 600w, https:\/\/key2compliance.com\/wp-content\/uploads\/2026\/01\/tutorial-application-clinical-investigations-play-wide.avif 860w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ca1d148 elementor-widget elementor-widget-text-editor\" data-id=\"ca1d148\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>S\u00e5 g\u00f6r man r\u00e4tt n\u00e4r man fyller i MDR-ans\u00f6kningar<\/strong> <br \/>-Vad man ska l\u00e4mna in, var och varf\u00f6r \u2013 En praktisk guide till ans\u00f6kningar om kliniska pr\u00f6vningar enligt MDR<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-acecc8b e-con-full e-flex e-con e-child\" data-id=\"acecc8b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0b861b9 elementor-widget elementor-widget-image\" data-id=\"0b861b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/vimeo.com\/1138087587\" target=\"_blank\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"768\" height=\"414\" src=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/11\/tutorial-monitoring-document_play-768x414.avif\" class=\"attachment-medium_large size-medium_large wp-image-131057\" alt=\"Guide - Modern \u00f6vervakning och dokumenthantering\" srcset=\"https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/11\/tutorial-monitoring-document_play-768x414.avif 768w, https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/11\/tutorial-monitoring-document_play-300x162.avif 300w, https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/11\/tutorial-monitoring-document_play-600x324.avif 600w, https:\/\/key2compliance.com\/wp-content\/uploads\/2025\/11\/tutorial-monitoring-document_play.avif 860w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-867aa74 elementor-widget elementor-widget-text-editor\" data-id=\"867aa74\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>L\u00e4r dig mer om moderna \u00f6vervakningsstrategier, regelefterlevnad och smartare eTMF-arbetsfl\u00f6den f\u00f6r att st\u00f6dja effektiva och inspektionsklara kliniska studier!<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-14b7fc1 e-con-full e-flex e-con e-child\" data-id=\"14b7fc1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<main class=\"elementor-element elementor-element-f4dbf86 e-con-full e-flex e-con e-child\" data-id=\"f4dbf86\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-32b3a63 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"32b3a63\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c46927e elementor-widget elementor-widget-menu-anchor\" data-id=\"c46927e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"clinicalprojectmanager\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-72fc53c elementor-widget elementor-widget-heading\" data-id=\"72fc53c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Tj\u00e4nster inom klinisk projektledning<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33c3afa elementor-widget elementor-widget-heading\" data-id=\"33c3afa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Fr\u00e5n studieuppl\u00e4gg till slutlig rapport \u2013 expertv\u00e4gledning i varje steg.<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7d363c6 elementor-widget elementor-widget-text-editor\" data-id=\"7d363c6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>En klinisk projektledare (CPM) fr\u00e5n GBA Key2Compliance \u00e4r mer \u00e4n en samordnare. Som er betrodda kliniska r\u00e5dgivare v\u00e4gleder v\u00e5ra CPM:er er studie fr\u00e5n id\u00e9 till f\u00e4rdigst\u00e4llande \u2013 och s\u00e4kerst\u00e4ller vetenskaplig integritet, regulatorisk anpassning och operativ excellens hela v\u00e4gen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-86f2dac elementor-widget elementor-widget-heading\" data-id=\"86f2dac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Vad som skiljer v\u00e5ra CPM:er \u00e5t<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33b6a5d elementor-widget elementor-widget-text-editor\" data-id=\"33b6a5d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Oavsett om du f\u00f6rbereder en f\u00f6rsta studien p\u00e5 m\u00e4nniska (FIH) f\u00f6r att visa proof-of-concept p\u00e5 en tidig prototypprodukt, planerar en valideringsstudie f\u00f6r CE-m\u00e4rkning, eller utf\u00f6r uppf\u00f6ljning efter godk\u00e4nnande utifr\u00e5n kliniska data eller prestandadata (PMCF\/PMPF), fungerar v\u00e5ra CPM:er som er kliniska projektledare och enda kontaktpunkt under hela processen.<\/p><p>CPM bidrar direkt till studiedesignen, hanterar protokoll- och inl\u00e4mningsutveckling, sk\u00f6ter kommunikationen med myndigheter och s\u00e4kerst\u00e4ller anpassning till s\u00e5v\u00e4l dina aff\u00e4rsm\u00e5l som regulatoriska krav.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t<a class=\"elementor-element elementor-element-dc245cd e-con-full e-flex e-con e-child\" data-id=\"dc245cd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-24e7a00 elementor-widget elementor-widget-button\" data-id=\"24e7a00\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/key2compliance.com\/our-services\/clinical-development\/#contact\">\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\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-arrow-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">KONTAKTA V\u00c5RA EXPERTER<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98c17fd elementor-widget elementor-widget-heading\" data-id=\"98c17fd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">L\u00e4s mer<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13fccc9 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"13fccc9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/key2compliance.com\/safety-management-for-medical-device-and-ivd-studies\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-chevron-right\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Klinisk s\u00e4kerhetshantering<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/key2compliance.com\/clinical-data-management\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-chevron-right\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Klinisk datahantering<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/key2compliance.com\/etmf-electronic-trial-master-file\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-chevron-right\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">eTMF \u2013 Elektroniskt pr\u00f6vningsmasterregister<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/main>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/main>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Clinical Investigations and Performance Studies Clinical studies for medical devices and in vitro diagnostics (IVDs) follow a structured process, typically divided into three key phases. Each phase comes with specific regulatory requirements and deliverables, in line with: ISO 14155 \u2013 Clinical investigation of medical devices for human subjects \u2013 Good clinical practice\u00a0 ISO 20916 \u2013 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":130576,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-128468","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/pages\/128468","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/comments?post=128468"}],"version-history":[{"count":5,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/pages\/128468\/revisions"}],"predecessor-version":[{"id":132196,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/pages\/128468\/revisions\/132196"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/media\/130576"}],"wp:attachment":[{"href":"https:\/\/key2compliance.com\/sv\/wp-json\/wp\/v2\/media?parent=128468"}],"curies":[{"name":"bra spelat","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}