{"id":55022,"date":"2025-08-19T18:00:51","date_gmt":"2025-08-19T16:00:51","guid":{"rendered":"https:\/\/clariscience.com\/servizi-clariscience\/regulatory-affairs\/survey-evidence-builder"},"modified":"2026-05-16T19:30:04","modified_gmt":"2026-05-16T17:30:04","slug":"survey-evidence-builder","status":"publish","type":"servizi-clariscience","link":"https:\/\/clariscience.com\/en\/services\/regulatory-affairs\/survey-evidence-builder","title":{"rendered":"Survey evidence builder"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"55022\" class=\"elementor elementor-55022 elementor-54898\" data-elementor-post-type=\"servizi-clariscience\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-92d99b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"92d99b4\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-bd61d65\" data-id=\"bd61d65\" 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-00aed92 elementor-widget elementor-widget-text-editor\" data-id=\"00aed92\" 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<h2><strong>Reliable clinical evidence collected methodically and in compliance with European Regulation.<\/strong><\/h2><p>Under Regulation (EU) 2017\/745 (MDR), post-market data collection is essential to ensure the safety and performance of medical devices throughout their entire lifecycle.<\/p><p><strong>High-Quality PMCF surveys<\/strong> are a strategic tool for generating <em>real-world<\/em> clinical evidence, especially when:<\/p><ul><li>The medical device has gaps in clinical data<\/li><li>Specific claims need to be supported<\/li><\/ul><p>In such cases, surveys are a valuable method for collecting meaningful information to demonstrate compliance with applicable GSPRs, complementing other PMCF activities tailored to the device.<\/p><p>Clariscience has developed a comprehensive service for the design and implementation of <strong>High-Quality PMCF surveys<\/strong>, in accordance with Appendix III of MDCG 2020-6 and aligned with MDR principles.<\/p><p>A rigorous and sustainable approach, designed to transform data collection into a <strong>concrete clinical and regulatory advantage<\/strong>.<\/p><p>A <strong>complementary and value-driven<\/strong> activity designed to accelerate data collection, strengthen the manufacturer\u2019s regulatory strategy and support clinical investigations by integrating necessary evidence<\/p><p>A <strong>practical tool<\/strong> to support the manufacturer throughout the device life cycle<\/p><h2><strong>Our 4-step method:<\/strong><\/h2><h3><strong style=\"color: #282828; font-size: 16px;\">1.Clinical-regulatory context analysis<\/strong><\/h3><p>We review existing documentation to identify clinical gaps and define clear objectives aligned with the device\u2019s claims and clinical benefits in order to develop targeted survey questions.<\/p><h3><strong>2.Protocol design<\/strong><\/h3><p>We draft a streamlined yet robust protocol, that ensures consistency, traceability, and methodological rigor.<\/p><h3><strong>3.Statistical analysis plan<\/strong><\/h3><p>We develop a solid statistical plan to identify relevant metrics, optimize the survey structure, define the number of questions, and determine the appropriate sample size to ensure data validity and quality.<\/p><h3><strong>4.Questionnaire development<\/strong><\/h3><p>Based on thorough literature research and the survey\u2019s objectives, we design targeted questions to collect specific data aligned with the device\u2019s regulatory context.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec75d24 elementor-widget elementor-widget-text-editor\" data-id=\"ec75d24\" 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<h2><strong>When is a High-Quality PMCF survey useful?<\/strong><\/h2>\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-88bfea0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"88bfea0\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-887ff2d\" data-id=\"887ff2d\" 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-78e55e7 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"78e55e7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/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\">To address gaps in existing clinical data<\/span>\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<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/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\">As a complement to an ongoing clinical investigation<\/span>\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<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/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\">To collect evidence quickly and sustainably<\/span>\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<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/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\">To demonstrate proactive data collection throughout the device lifecycle<\/span>\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<\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f88b941 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f88b941\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-cd4cc7f\" data-id=\"cd4cc7f\" 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-7c27b46 elementor-widget elementor-widget-text-editor\" data-id=\"7c27b46\" 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>Every device is unique. So is our strategy: we evaluate each project individually to define the most suitable clinical-regulatory strategy.<\/p><p><strong><i>W<\/i>ondering if a High-Quality PMCF survey is the right tool for your device?<\/strong><\/p><p><br><a href=\"https:\/\/clariscience.com\/en\/contacts\" target=\"_blank\" rel=\"noopener\">Contact us<\/a> for a free preliminary assessment.<\/p><p><br>With <strong>Clariscience<\/strong>, data collection creates evidence. <strong>And evidence, value<\/strong>.<\/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},"featured_media":27849,"parent":39611,"template":"","settori-servizi":[560,566],"class_list":["post-55022","servizi-clariscience","type-servizi-clariscience","status-publish","has-post-thumbnail","hentry","settori-servizi-md-en","settori-servizi-xvi-en"],"acf":[],"yoast_head":"<title>Survey evidence builder | Clariscience<\/title>\n<meta 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