{"id":2071,"date":"2025-05-30T06:16:35","date_gmt":"2025-05-30T06:16:35","guid":{"rendered":"https:\/\/medical-hub.info\/?page_id=2071"},"modified":"2025-07-01T13:15:30","modified_gmt":"2025-07-01T13:15:30","slug":"oczinka-vidpovidnosti-shlyahom-audytu","status":"publish","type":"page","link":"https:\/\/medical-hub.info\/en\/services\/conformity-assessment-for-medical-devices\/conformity-assessment-through-audit\/","title":{"rendered":"Conformity assessment by audit"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"2071\" class=\"elementor elementor-2071\" data-elementor-post-type=\"page\">\n\t\t\t\t<section class=\"elementor-element elementor-element-3d9ba24 cst-grade-audit-hero e-flex e-con-boxed e-con e-parent\" data-id=\"3d9ba24\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f3afbcf e-con-full e-flex e-con e-child\" data-id=\"f3afbcf\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-6a3b7b4 e-con-full cst-breadcrums-box e-flex e-con e-child\" data-id=\"6a3b7b4\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-01bfb13 elementor-widget-mobile__width-initial cst-scroll-breadcrmbs-btn js-cst-scroll-breadcrmbs-btn elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-button\" data-id=\"01bfb13\" 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\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/en\/\">\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<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M4 12H20M4 12L10 6M4 12L10 18\" stroke=\"#141A2A\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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-a8819f8 cst-breadcrumbs js-cst-breadcrumbs elementor-widget-mobile__width-initial elementor-widget elementor-widget-hfe-breadcrumbs-widget\" data-id=\"a8819f8\" data-element_type=\"widget\" data-widget_type=\"hfe-breadcrumbs-widget.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<nav aria-label=\"Breadcrumb\"><ul class=\"hfe-breadcrumbs hfe-breadcrumbs-show-home\"><li class=\"hfe-breadcrumbs-item hfe-breadcrumbs-first\"><span class=\"hfe-breadcrumbs-home-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M20 18.1833V10.9C20 10.153 19.6839 9.43656 19.1213 8.90834L13.4142 3.54999C12.6332 2.81667 11.3668 2.81667 10.5858 3.54999L4.87868 8.90834C4.31607 9.43656 4 10.153 4 10.9V18.1833C4 19.7389 5.34315 21 7 21H9V17C9 15.8954 9.89543 15 11 15H13C14.1046 15 15 15.8954 15 17V21H17C18.6569 21 20 19.7389 20 18.1833Z\" stroke=\"#141A2A\" stroke-width=\"2\" stroke-linejoin=\"round\"><\/path><\/svg><\/span><a href=\"https:\/\/medical-hub.info\/en\"><span class=\"hfe-breadcrumbs-text\"><\/span><\/a><\/li><\/ul><\/nav>\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-0c7b134 e-con-full e-flex e-con e-child\" data-id=\"0c7b134\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-2dd7991 e-con-full e-flex e-con e-child\" data-id=\"2dd7991\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3bd2663 cst-hero-title elementor-widget elementor-widget-heading\" data-id=\"3bd2663\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Conformity assessment through <span class=\"cst-color-text\">procedure<\/span> \u0434\u043b\u044f <span class=\"cst-color-text\">for medical devices<\/span><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bdfe895 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"bdfe895\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">An important step to confirm the compliance of medical devices with the requirements of Ukrainian legislation. Confirm the compliance of your products with the requirements of Ukrainian legislation with expert support at every stage<\/p>\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-9c362a3 e-con-full e-flex e-con e-child\" data-id=\"9c362a3\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-c991e5d e-con-full cst-btn-group-wp red js-cst-btn-group e-flex e-con e-child\" data-id=\"c991e5d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-271648e cst-phone-btn cst-button-icon no-icon-tablet cst-primary-btn js-cst-phone blur elementor-tablet-align-justify elementor-widget-tablet__width-initial elementor-align-justify elementor-widget__width-initial elementor-widget elementor-widget-button\" data-id=\"271648e\" 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\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">+38 093 414 02 22<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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-682db70 cst-phone-btn cst-button-icon cst-primary-arrow-btn js-cst-phone-icon blur elementor-widget elementor-widget-button\" data-id=\"682db70\" 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\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#\">\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<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M11.7925 14.742L9.25195 12.2057C8.43422 11.3893 8.43422 10.0657 9.25195 9.24935C9.98275 8.51977 10.071 7.36701 9.45987 6.53498L7.37385 3.69514C6.75631 2.85444 5.53346 2.76108 4.79506 3.49826C3.67086 4.62058 2.91814 6.10588 3.00713 7.6906C3.44184 15.4326 9.49836 20.6079 16.3476 20.993C17.9183 21.0813 19.3811 20.3229 20.4935 19.2123C21.2429 18.4642 21.148 17.2252 20.2933 16.5995L17.4726 14.5344C16.6392 13.9242 15.4845 14.0124 14.7537 14.742C13.936 15.5583 12.6102 15.5583 11.7925 14.742Z\" stroke=\"#D78861\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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-bb7275e e-con-full cst-btn-group-wp js-cst-btn-group blue e-flex e-con e-child\" data-id=\"bb7275e\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc933c1 cst-primary-btn js-cst-open-form-btn elementor-tablet-align-justify elementor-widget-tablet__width-initial elementor-align-justify elementor-widget__width-initial elementor-widget elementor-widget-button\" data-id=\"dc933c1\" 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\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/en\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Get a consultation<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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-d22f6b6 cst-primary-arrow-btn js-cst-open-form-btn elementor-widget elementor-widget-button\" data-id=\"d22f6b6\" 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\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/en\/\">\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<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M17 7V17M17 7H7M17 7L7 17\" stroke=\"#141A2A\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<\/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<\/section>\n\t\t<section class=\"elementor-element elementor-element-96872be e-flex e-con-boxed e-con e-parent\" data-id=\"96872be\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-c53efe0 e-con-full e-flex e-con e-child\" data-id=\"c53efe0\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-897af2c e-con-full cst-grade-audit-tips-box e-flex e-con e-child\" data-id=\"897af2c\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e0b25cf e-con-full e-flex e-con e-child\" data-id=\"e0b25cf\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49c53c8 cst-title elementor-widget elementor-widget-heading\" data-id=\"49c53c8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span class=\"cst-color-text\">What does conformity<\/span> assessment involve?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e6d3b96 elementor-widget elementor-widget-heading\" data-id=\"e6d3b96\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">This procedure involves assessing the manufacturer's quality management system and ensuring compliance with all necessary standards<\/p>\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-7d0cf7d e-con-full e-flex e-con e-child\" data-id=\"7d0cf7d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-421e9e6 elementor-widget elementor-widget-shortcode\" data-id=\"421e9e6\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">    <ul class=\"cst-tips-list cst-reset-list\">\r\n                    <li class=\"cst-item\">\r\n                <p class=\"cst-tip\">\r\n                    <svg width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\r\n                        <path\r\n                            d=\"M7.5 12.5L10.5 15.5L16.5 9.5M12 22C6.47715 22 2 17.5228 2 12C2 6.47715 6.47715 2 12 2C17.5228 2 22 6.47715 22 12C22 17.5228 17.5228 22 12 22Z\"\r\n                            stroke=\"#54E1CD\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" \/>\r\n                    <\/svg>\r\n                    <span>Important to know<\/span>\r\n                <\/p>\r\n                <p class=\"cst-desc\">\r\n                    Starting from 2021, most audits are conducted online, which significantly reduces time and costs for both manufacturers and auditors. This approach allows for a faster and more efficient assessment of compliance, although on-site audits are still required for certain products.                <\/p>\r\n            <\/li>\r\n            <\/ul>\r\n    <\/div>\n\t\t\t\t\t\t<\/div>\n\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-3b98f42 e-con-full cst-step-help-box e-flex e-con e-child\" data-id=\"3b98f42\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ac1dd70 elementor-widget__width-initial cst-title elementor-widget elementor-widget-heading\" data-id=\"ac1dd70\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span class=\"cst-color-text\">Medical HUB<\/span> provides comprehensive support at every stage<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b58d20 elementor-widget elementor-widget-shortcode\" data-id=\"3b58d20\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">    <ul class=\"cst-faq-list cst-reset-list\">\r\n                    <li class=\"cst-item js-cst-faq-item\">\r\n                <div class=\"cst-question-box js-cst-faq-question-box\">\r\n                    <button type=\"button\" class=\"cst-faq-btn cst-question js-cst-faq-question\">\r\n                        <span class=\"cst-question-text\">Consultations on technical documentation<\/span>\r\n                    <\/button>\r\n\r\n                    <button type=\"button\" aria-label=\"Open answer\" class=\"cst-faq-btn cst-toggle-btn js-cst-faq-btn is-close\">\r\n                        <svg class=\"cst-icon\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"\r\n                            xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\r\n                            <path d=\"M6 9L11.2929 14.2929C11.6834 14.6834 12.3166 14.6834 12.7071 14.2929L18 9\" stroke=\"#141A2A\"\r\n                                stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" \/>\r\n                        <\/svg>\r\n                    <\/button>\r\n                <\/div>\r\n                <div class=\"cst-answer-box js-cst-answer-box\">\r\n                    <p class=\"cst-answer js-cst-faq-answer is-open\">Development, adaptation and verification of technical documentation<\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item js-cst-faq-item\">\r\n                <div class=\"cst-question-box js-cst-faq-question-box\">\r\n                    <button type=\"button\" class=\"cst-faq-btn cst-question js-cst-faq-question\">\r\n                        <span class=\"cst-question-text\">Coordination of actions of the authorized representative<\/span>\r\n                    <\/button>\r\n\r\n                    <button type=\"button\" aria-label=\"Open answer\" class=\"cst-faq-btn cst-toggle-btn js-cst-faq-btn is-close\">\r\n                        <svg class=\"cst-icon\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"\r\n                            xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\r\n                            <path d=\"M6 9L11.2929 14.2929C11.6834 14.6834 12.3166 14.6834 12.7071 14.2929L18 9\" stroke=\"#141A2A\"\r\n                                stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" \/>\r\n                        <\/svg>\r\n                    <\/button>\r\n                <\/div>\r\n                <div class=\"cst-answer-box js-cst-answer-box\">\r\n                    <p class=\"cst-answer js-cst-faq-answer is-open\">Legal and organizational support<\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item js-cst-faq-item\">\r\n                <div class=\"cst-question-box js-cst-faq-question-box\">\r\n                    <button type=\"button\" class=\"cst-faq-btn cst-question js-cst-faq-question\">\r\n                        <span class=\"cst-question-text\">Selection of a conformity assessment body<\/span>\r\n                    <\/button>\r\n\r\n                    <button type=\"button\" aria-label=\"Open answer\" class=\"cst-faq-btn cst-toggle-btn js-cst-faq-btn is-close\">\r\n                        <svg class=\"cst-icon\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"\r\n                            xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\r\n                            <path d=\"M6 9L11.2929 14.2929C11.6834 14.6834 12.3166 14.6834 12.7071 14.2929L18 9\" stroke=\"#141A2A\"\r\n                                stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" \/>\r\n                        <\/svg>\r\n                    <\/button>\r\n                <\/div>\r\n                <div class=\"cst-answer-box js-cst-answer-box\">\r\n                    <p class=\"cst-answer js-cst-faq-answer is-open\">Assistance in the selection of a conformity assessment body depending on the choice and other aspects<\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item js-cst-faq-item\">\r\n                <div class=\"cst-question-box js-cst-faq-question-box\">\r\n                    <button type=\"button\" class=\"cst-faq-btn cst-question js-cst-faq-question\">\r\n                        <span class=\"cst-question-text\">Preparation of a declaration of conformity<\/span>\r\n                    <\/button>\r\n\r\n                    <button type=\"button\" aria-label=\"Open answer\" class=\"cst-faq-btn cst-toggle-btn js-cst-faq-btn is-close\">\r\n                        <svg class=\"cst-icon\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\"\r\n                            xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\r\n                            <path d=\"M6 9L11.2929 14.2929C11.6834 14.6834 12.3166 14.6834 12.7071 14.2929L18 9\" stroke=\"#141A2A\"\r\n                                stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" \/>\r\n                        <\/svg>\r\n                    <\/button>\r\n                <\/div>\r\n                <div class=\"cst-answer-box js-cst-answer-box\">\r\n                    <p class=\"cst-answer js-cst-faq-answer is-open\">Support until receipt of certificate<\/p>\r\n                <\/div>\r\n            <\/li>\r\n            <\/ul>\r\n    <\/div>\n\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-ba49ba2 e-con-full cst-steps-audit e-flex e-con e-child\" data-id=\"ba49ba2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-75047c4 cst-title elementor-widget elementor-widget-heading\" data-id=\"75047c4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span class=\"cst-color-text\">Stages<\/span> of the audit <span class=\"cst-color-text\">procedure<\/span><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6bd2425 elementor-widget elementor-widget-shortcode\" data-id=\"6bd2425\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">    <ul class=\"cst-services-list cst-reset-list\">\r\n                    <li class=\"cst-item\">\r\n                <div class=\"cst-box\">\r\n                    <p class=\"cst-service-name\">Preparation of technical documentation<\/p>\r\n\r\n                    <p class=\"cst-service-decs\">\r\n                        The manufacturer submits to the conformity assessment body the technical documentation for the products, as well as documents on the quality management system. It is important to ensure that the documentation meets the requirements of the authority, in particular with regard to translations and legalization.                    <\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item\">\r\n                <div class=\"cst-box\">\r\n                    <p class=\"cst-service-name\">Conducting an audit<\/p>\r\n\r\n                    <p class=\"cst-service-decs\">\r\n                        After submitting the documentation, the authority initiates an audit. Online audits are conducted according to pre-agreed schedules with a detailed audit plan. If necessary, on-site audits are organized                    <\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item\">\r\n                <div class=\"cst-box\">\r\n                    <p class=\"cst-service-name\">Resolving comments<\/p>\r\n\r\n                    <p class=\"cst-service-decs\">\r\n                        If comments arise during the audit, the manufacturer is given time to eliminate them and submit additional documentation                    <\/p>\r\n                <\/div>\r\n            <\/li>\r\n                    <li class=\"cst-item\">\r\n                <div class=\"cst-box\">\r\n                    <p class=\"cst-service-name\">Issuance of the certificate<\/p>\r\n\r\n                    <p class=\"cst-service-decs\">\r\n                        After successful completion of the audit, a certificate of conformity assessment is issued, valid for 5 years. Based on this certificate, the manufacturer or his authorized representative has the right to issue a declaration of conformity                    <\/p>\r\n                <\/div>\r\n            <\/li>\r\n            <\/ul>\r\n    <\/div>\n\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-4618851 e-con-full cst-summary-block e-flex e-con e-child\" data-id=\"4618851\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cacd1d0 elementor-widget__width-initial cst-title elementor-widget elementor-widget-heading\" data-id=\"cacd1d0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><span class=\"cst-color-text\">Regular surveillance<\/span> audits to maintain compliance<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4058ff3 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"4058ff3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">After the certificate is issued, surveillance audits are conducted annually, mostly online, with the possibility of making changes to the valid certificate, such as changing the name of products, expanding or reducing the list of products, changing the address or name of the manufacturer<\/p>\t\t\t\t<\/div>\n\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<\/section>\n\t\t<div class=\"elementor-element elementor-element-dc7bbfc e-flex e-con-boxed e-con e-parent\" data-id=\"dc7bbfc\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6893d2d e-con-full e-flex e-con e-child\" data-id=\"6893d2d\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-576e9e3 elementor-widget elementor-widget-heading\" data-id=\"576e9e3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Medical HUB offers comprehensive support at every stage of the procedure<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-735ceb2 elementor-widget elementor-widget-heading\" data-id=\"735ceb2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Do you have any questions? <br \/> \u2028Contact us for a consultation<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-283acfa e-con-full cst-btn-group-wp js-cst-btn-group blue e-flex e-con e-child\" data-id=\"283acfa\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2d9639e cst-primary-btn  js-cst-open-form-btn elementor-tablet-align-justify elementor-widget-tablet__width-initial elementor-align-justify elementor-widget__width-initial elementor-widget elementor-widget-button\" data-id=\"2d9639e\" 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\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/en\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request a 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