{"id":8157,"date":"2024-01-12T03:27:50","date_gmt":"2024-01-12T03:27:50","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8157"},"modified":"2024-01-12T19:55:49","modified_gmt":"2024-01-12T19:55:49","slug":"medical-device-ivd-usability","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/medical-device-ivd-usability\/","title":{"rendered":"Medical Device &#038; IVD Usability Testing and FDA Human Factors Requirements"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8157\" class=\"elementor elementor-8157\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" 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-4264d41\" data-id=\"4264d41\" 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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&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-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\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-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/12\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 12, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Medical Device & IVD Usability Testing and FDA Human Factors Requirements<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1773\" height=\"1182\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/08\/usability-testing.jpg-1.jpeg\" class=\"attachment-full size-full wp-image-5042\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/08\/usability-testing.jpg-1.jpeg 1773w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/08\/usability-testing.jpg-1-300x200.jpeg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/08\/usability-testing.jpg-1-1024x683.jpeg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/08\/usability-testing.jpg-1-768x512.jpeg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/08\/usability-testing.jpg-1-1536x1024.jpeg 1536w\" sizes=\"(max-width: 1773px) 100vw, 1773px\" \/>\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 class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>The technology behind your device may be brilliant, but sales will suffer if your user interface and\/or ergonomics are subpar. Worse yet, you open your company and patients\/users to risks that might have been avoided with proper device usability testing.<\/p><p>FDA has long placed an emphasis on usability testing, which they refer to as\u00a0<em>human factors<\/em>. In recent years, the European Union has also placed far more emphasis on risk management, an important facet of which is how the user interfaces with the device.<\/p><h3>\u00a0<\/h3><h3>Why Do We Need to Do Device Usability Testing?<\/h3><p>These two documents will help you apply the customer requirements found in section 820.30 of the FDA Quality System Regulation, as well as clauses within ISO 13485:2016, including:<\/p><ul><li><strong>Clause 5.2,<\/strong>\u00a0which states that usability is a customer requirement.<\/li><li><strong>Clause 7.2,<\/strong>\u00a0which states that you should determine any user training needed to ensure specified performance and safe use of the medical device.<\/li><\/ul><p>Although IEC 62366-1 is barely mentioned in ISO 13485:2016, when the next version comes out it is expected that usability will be emphasized far more.<\/p><div class=\"box-cur\"><ul><li><strong>Usability engineering<\/strong>\u00a0focuses on the interaction between users, devices, and the use environment.<\/li><li><strong>Usability testing<\/strong>\u00a0discovers the potential for user errors so they can be addressed.<\/li><li><strong>Human factors<\/strong>\u00a0help reduce medical errors and, therefore, harm to patients.<\/li><\/ul><\/div><h3>\u00a0<\/h3><h3>FDA Human Factors Engineering<\/h3><ol><li>Conclusion and summary of processes and results to support a conclusion that the device is safe<\/li><li>Description of intended device users, uses, use environments, and training<\/li><li>Description of the device user interface<\/li><li>Summary of known use problems<\/li><li>Analysis of hazards and risks associated with the device<\/li><li>Summary of preliminary analysis and evaluations<\/li><li>Description and categorization of critical tasks<\/li><li>Details of human factors validation testing<\/li><\/ol><p>During this process you will profile your\u00a0<strong>typical device users<\/strong>\u00a0(physical size, cognitive abilities, language skills, etc.);\u00a0<strong>device use environment<\/strong>\u00a0(lighting, noise, clutter in the room, etc.); and the\u00a0<strong>device user interface<\/strong>\u00a0(size\/shape of device, indicator lights, graphical user interface, etc.).<\/p><p>This guidance should be used in conjunction with IEC 62366-1, which is a consensus standard recognized by FDA.<\/p><h3>\u00a0<\/h3><h3>European Usability Requirements<\/h3><p>The word\u00a0<em>usability<\/em>\u00a0may only be mentioned twice in the entire MDR, but that doesn\u2019t mean it\u2019s not an important factor in risk management compliance. Again, even though IEC 62366-1 is not yet a harmonized standard under the MDR or IVDR, it eventually will be and you are advised to follow it for MDR\/IVDR compliance, just as you would for FDA compliance. In the MDR,\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/'uri=CELEX:32017R0745&amp;from=EN#d1e32-94-1\" target=\"_blank\" rel=\"noopener noreferrer\">Annex I<\/a>\u00a0contains several references highlighting the need for manufacturers to take medical device usability seriously. They include:<br \/>Similar clauses can be found throughout the\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/'uri=OJ:L:2017:117:FULL&amp;from=EN\" target=\"_blank\" rel=\"noopener noreferrer\">IVDR<\/a>\u00a0by searching for the word\u00a0<em>ergonomic<\/em>.<\/p><h3>\u00a0<\/h3><h3>Usability Testing Is a Postmarket Activity Too!<\/h3><h3>Want to Learn More?<\/h3>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3400fd elementor-widget elementor-widget-shortcode\" data-id=\"a3400fd\" 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<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. 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and FDA Human Factors Requirements The technology behind your device may be brilliant, but sales will suffer if your user interface and\/or ergonomics are subpar. Worse yet, you open your company and patients\/users to risks that might have been avoided with proper device usability testing. FDA has long placed [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5042,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[12],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/medical-device-ivd-usability\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Medical Device &#038; IVD Usability Testing and FDA Human Factors Requirements The technology behind your device may be brilliant, but sales will suffer if your user interface and\/or ergonomics are subpar. 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FDA has long placed [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/medical-device-ivd-usability\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2024-01-12T03:27:50+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-12T19:55:49+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/08\/usability-testing.jpg-1.jpeg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1773\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1182\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/medical-device-ivd-usability\/","og_locale":"en_US","og_type":"article","og_description":"Medical Device &#038; IVD Usability Testing and FDA Human Factors Requirements The technology behind your device may be brilliant, but sales will suffer if your user interface and\/or ergonomics are subpar. Worse yet, you open your company and patients\/users to risks that might have been avoided with proper device usability testing. 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