{"id":80218,"date":"2022-12-07T16:41:40","date_gmt":"2022-12-07T15:41:40","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?page_id=80218"},"modified":"2025-03-19T07:46:05","modified_gmt":"2025-03-19T06:46:05","slug":"start-up-tutorials","status":"publish","type":"page","link":"https:\/\/lightweb.dev\/s\/key2compliance\/start-up-tutorials\/","title":{"rendered":"Start-up tutorials"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"80218\" class=\"elementor elementor-80218\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4a1643c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4a1643c\" data-element_type=\"section\" data-e-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-50 elementor-top-column elementor-element elementor-element-d7ed204\" data-id=\"d7ed204\" 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-ee2b051 elementor-widget elementor-widget-heading\" data-id=\"ee2b051\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Start-up tutorials<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-47f3a48 elementor-widget elementor-widget-heading\" data-id=\"47f3a48\" 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\">A guide to regulatory compliance<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e9ef7bd elementor-widget elementor-widget-text-editor\" data-id=\"e9ef7bd\" 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>Taking your medical device from idea to market can be a complex process which requires knowledge of medical device regulations. This introduction will make you aware what is needed to obtain a CE mark. The tutorials will guide you through the process; realising your ideas from research and development; to the essential requirements for CE-marking and to get market access.<\/p><p>If you are a start-up with little to no knowledge on medical device regulations and the CE-marking process, our guide is a quick way to understand the basics and apply them to your development process.<\/p>\t\t\t\t\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-e97329c\" data-id=\"e97329c\" 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-9cfb011 elementor-widget elementor-widget-image\" data-id=\"9cfb011\" 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=\"768\" height=\"417\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/02\/uic-featured-768x417.avif\" class=\"attachment-medium_large size-medium_large wp-image-82036\" alt=\"Medical Devices from idea to market\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/02\/uic-featured-768x417.avif 768w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/02\/uic-featured-300x163.avif 300w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/02\/uic-featured-600x326.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/02\/uic-featured.avif 860w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\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-013012f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"013012f\" data-element_type=\"section\" data-e-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-eb3044d\" data-id=\"eb3044d\" 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-3529e3f elementor-widget elementor-widget-text-editor\" data-id=\"3529e3f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tThe 7 tutorials are a step-by-step guide through the medical device regulations (and indicate which of them applies to you), the Quality Management System, and risk management. They will lead you and explain everything else you need to know about regulatory compliance for a successful product launch on the market.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78c5b86 elementor-button-warning elementor-align-left elementor-widget elementor-widget-button\" data-id=\"78c5b86\" 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-md\" href=\"#form\">\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-angle-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Get a link to the tutorials<\/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-e69dc5c elementor-widget elementor-widget-spacer\" data-id=\"e69dc5c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\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-2816bbc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2816bbc\" data-element_type=\"section\" data-e-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-4100bc3\" data-id=\"4100bc3\" 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-4920a19 elementor-widget elementor-widget-spacer\" data-id=\"4920a19\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d89547b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d89547b\" data-element_type=\"section\" data-e-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-50 elementor-inner-column elementor-element elementor-element-c067fe4\" data-id=\"c067fe4\" 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-72b514d elementor-widget elementor-widget-heading\" data-id=\"72b514d\" 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\">Medical Devices - From Idea to Market<\/h2>\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-inner-column elementor-element elementor-element-6e88a9b\" data-id=\"6e88a9b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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 class=\"elementor-element elementor-element-8002073 elementor-widget elementor-widget-heading\" data-id=\"8002073\" 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\">Free on-demand tutorials for start-up companies<\/h3>\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-a3c6ab4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a3c6ab4\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\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-50 elementor-top-column elementor-element elementor-element-ddb8fb5\" data-id=\"ddb8fb5\" 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-15749fe elementor-widget elementor-widget-image\" data-id=\"15749fe\" 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=\"#form\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"600\" height=\"338\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-0.avif\" class=\"attachment-medium_large size-medium_large wp-image-81104\" alt=\"Medical Devices from idea to market -Intro - Training contents and purpose\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-0.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-0-300x169.avif 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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-322a61c elementor-widget elementor-widget-text-editor\" data-id=\"322a61c\" 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>0. Content and purpose<br \/><\/b><span style=\"color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); font-size: 1rem;\">An introduction to the training series and why it is so important to understand the regulatory processes when developing a medical device.\u00a0<\/span><b><br \/><\/b><\/p><p><a href=\"#form\"><span style=\"font-family: Quicksand;\">Get access &gt;<\/span><\/a><\/p><p><span style=\"font-family: Quicksand;\">\u00a0<\/span><\/p>\t\t\t\t\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-e6e48f5\" data-id=\"e6e48f5\" 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-71c3664 elementor-widget elementor-widget-image\" data-id=\"71c3664\" 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=\"#form\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"600\" height=\"338\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-1.avif\" class=\"attachment-large size-large wp-image-81105\" alt=\"Medical Devices from idea to market - Module 1 - Importance of Intended Purpose, or \u201cis my product a Medical Device, or not?\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-1.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-1-300x169.avif 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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-29bf3e7 elementor-widget elementor-widget-text-editor\" data-id=\"29bf3e7\" 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>1. Importance of Intended Purpose. Medical Device, or not?<br \/><\/b>How do I know if my innovation is classified as a medical device, and why is it important? &#8211; Knowing which regulation that applies when placing a product on the market is crucial: incorrect assumptions may lead to unexpected costs and severe delays in time to market.<\/p><p><a style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); background-color: #f7f7f7; font-size: 1rem;\" href=\"#form\">Get access &gt;<\/a><\/p>\t\t\t\t\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-f018adc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f018adc\" data-element_type=\"section\" data-e-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-50 elementor-top-column elementor-element elementor-element-350c1be\" data-id=\"350c1be\" 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-356cc8d elementor-widget elementor-widget-image\" data-id=\"356cc8d\" 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=\"#form\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"600\" height=\"338\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-2.avif\" class=\"attachment-medium_large size-medium_large wp-image-81109\" alt=\"Medical Devices from idea to market - Module 2 - Medical Device Regulations \u2013 what is their purpose, and how does it impact me?\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-2.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-2-300x169.avif 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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-765ac42 elementor-widget elementor-widget-text-editor\" data-id=\"765ac42\" 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>2. Regulations \u2013 Why do they exist, and how does it impact me?<\/b><br>\nWhat is the purpose of medical device regulations, and what is their impact for me, as a designer\/inventor\/owner of a start-up company? For a device to become CE-marked, the legal manufacturer must verify compliance to the regulations, in proportion to the risk. But how should this be done?<\/p><p><a href=\"#form\" style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); background-color: rgb(247, 247, 247); font-size: 1rem;\">Get access &gt;<\/a><br><\/p>\t\t\t\t\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-917d66a\" data-id=\"917d66a\" 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-6f44258 elementor-widget elementor-widget-image\" data-id=\"6f44258\" 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=\"#form\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"600\" height=\"338\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-3.avif\" class=\"attachment-medium_large size-medium_large wp-image-81110\" alt=\"Medical Devices from idea to market - Module 3 - What\u2019s my responsibility as device manufacturer, and how can a Quality system help?\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-3.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-3-300x169.avif 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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-e5e365c elementor-widget elementor-widget-text-editor\" data-id=\"e5e365c\" 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>3. What are the responsibilities of a \u201clegal manufacturer\u201d, and how can the Quality Management System support me?<br \/><\/b>Which requirements apply to me, as a legal manufacturer, before and after the launch? How can the QMS help me demonstrate compliance? The legal manufacturer is responsible for product performance and safety, throughout the device life cycle, and must define suitable means of control, using the quality management system.<\/p><p><a style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); background-color: #f7f7f7; font-size: 1rem;\" href=\"#form\">Get access &gt;<\/a><\/p>\t\t\t\t\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-d2ef0a4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d2ef0a4\" data-element_type=\"section\" data-e-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-50 elementor-top-column elementor-element elementor-element-9183564\" data-id=\"9183564\" 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-41e6121 elementor-widget elementor-widget-image\" data-id=\"41e6121\" 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=\"#form\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"600\" height=\"338\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-4.avif\" class=\"attachment-medium_large size-medium_large wp-image-81111\" alt=\"Medical Devices from idea to market -Module 4 - Processes \u2013 part I.\u00a0 Design &amp; Development Process\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-4.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-4-300x169.avif 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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-04001d5 elementor-widget elementor-widget-text-editor\" data-id=\"04001d5\" 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>4. Processes \u2013 part I. Design &amp; Development Process<br \/><\/b>How do I manage the transition from research into a controlled development process?<br \/>At the end of the research phase, resulting in a concept (or proposed solution) the product development process commences, and the design and development plan must be established. At this stage it is critical that the intended purpose of the device is clearly defined, to determine relevant design, verification, and validation activities.<\/p><p><a style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); background-color: #f7f7f7; font-size: 1rem;\" href=\"#form\">Get access &gt;<\/a><\/p>\t\t\t\t\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-196162b\" data-id=\"196162b\" 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-21d1e64 elementor-widget elementor-widget-image\" data-id=\"21d1e64\" 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=\"#form\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"600\" height=\"338\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-5.avif\" class=\"attachment-medium_large size-medium_large wp-image-81112\" alt=\"Medical Devices from idea to market - Module 5 - The Development Process for Medical Device Software\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-5.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-5-300x169.avif 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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-7304e0d elementor-widget elementor-widget-text-editor\" data-id=\"7304e0d\" 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>5. Medical Device Software, definitions, risk classification, and the development process<br \/><\/strong>Which criteria will determine whether the software I developed is considered a medical device, or not?<br \/>How is medical device software classified under MDR? Which standards and guidance documents do I need to take into consideration to ensure that my development process is aligned with the regulations?<\/p><p><a style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); background-color: #f7f7f7; font-size: 1rem;\" href=\"#form\">Get access &gt;<\/a><\/p>\t\t\t\t\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-d46fc8d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d46fc8d\" data-element_type=\"section\" data-e-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-50 elementor-top-column elementor-element elementor-element-785b8e1\" data-id=\"785b8e1\" 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-edc0cf6 elementor-widget elementor-widget-image\" data-id=\"edc0cf6\" 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=\"#form\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"600\" height=\"338\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-6.avif\" class=\"attachment-medium_large size-medium_large wp-image-81113\" alt=\"Medical Devices from idea to market - Module 6 - Processes \u2013 part II Quality Management System\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-6.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-6-300x169.avif 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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-f486e28 elementor-widget elementor-widget-text-editor\" data-id=\"f486e28\" 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>6. Processes \u2013 part II. Quality Management System<br \/><\/b>Signing a \u201cDeclaration of Conformity \u2013 what does it mean? What is behind a successful CE-marking process?<br \/>At the end of your development phase the technical documentation must be complete and well organized to facilitate a Notified Body review and reduce the number of questions, but you also need to show that your quality management system is both sufficient and efficient.<\/p><p><a style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); background-color: #f7f7f7; font-size: 1rem;\" href=\"#form\">Get access &gt;<\/a><\/p>\t\t\t\t\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-fb1f9aa\" data-id=\"fb1f9aa\" 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-07d6fa0 elementor-widget elementor-widget-image\" data-id=\"07d6fa0\" 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=\"#form\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"600\" height=\"338\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-7.avif\" class=\"attachment-medium_large size-medium_large wp-image-81114\" alt=\"Medical Devices from idea to market - Module 7 - Risk Management, Post-Market Surveillance and PMCF\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-7.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2023\/01\/frontbild-uic-7-300x169.avif 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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-5669b48 elementor-widget elementor-widget-text-editor\" data-id=\"5669b48\" 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>7. Post-Market Surveillance (PMS) and PMCF<br \/><\/b>Why do I need a Post-Market Surveillance plan, when I submit my Tech.Doc.? What is the purpose and scope of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)?<br \/>The Benefit-Risk Analysis shall be kept up to date over the device life cycle. Thus, the manufacturer must establish methods to collect clinical data, confirm risk assessment, and capture any new or emerging risks.<\/p><p><a style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); background-color: #f7f7f7; font-size: 1rem;\" href=\"#form\">Get access &gt;<\/a><\/p>\t\t\t\t\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-ab0bb4b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ab0bb4b\" data-element_type=\"section\" data-e-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-30d3888\" data-id=\"30d3888\" 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-2549648 elementor-widget elementor-widget-spacer\" data-id=\"2549648\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a6d7f4 elementor-widget elementor-widget-menu-anchor\" data-id=\"2a6d7f4\" 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=\"form\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e01fb5e elementor-widget elementor-widget-html\" data-id=\"e01fb5e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<iframe src=\"https:\/\/app.bwz.se\/key2compliance\/b\/v?subscribeto=12&ucrc=CA7749972F\" title=\"Ladda ned guide\" height=\"900\" width=\"400\" scrolling=\"no\" frameborder=\"0\"><\/iframe>\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},"excerpt":{"rendered":"<p>Start-up tutorials A guide to regulatory compliance Taking your medical device from idea to market can be a complex process which requires knowledge of medical device regulations. This introduction will make you aware what is needed to obtain a CE mark. The tutorials will guide you through the process; realising your ideas from research and [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-80218","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/pages\/80218","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/comments?post=80218"}],"version-history":[{"count":3,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/pages\/80218\/revisions"}],"predecessor-version":[{"id":124131,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/pages\/80218\/revisions\/124131"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=80218"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}