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2020-06-10
45.87.80.193
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2026-01-19
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HTTP/1.1 301 Moved PermanentlyConnection: Keep-AliveKeep-Alive: timeout5, max100Content-Type: text/htmlContent-Length: 795Date: Mon, 19 Jan 2026 18:46:23 GMTServer: LiteSpeedLocation: https://hf-insight.com/platform: hostingerpanel: hpanelContent-Security-Policy: upgrade-insecure-requests !DOCTYPE html>html styleheight:100%>head>meta nameviewport contentwidthdevice-width, initial-scale1, shrink-to-fitno />title> 301 Moved Permanently/title>style>@media (prefers-color-scheme:dark){body{background-color:#000!important}}/style>/head>body stylecolor: #444; margin:0;font: normal 14px/20px Arial, Helvetica, sans-serif; height:100%; background-color: #fff;>div styleheight:auto; min-height:100%; > div styletext-align: center; width:800px; margin-left: -400px; position:absolute; top: 30%; left:50%;> h1 stylemargin:0; font-size:150px; line-height:150px; font-weight:bold;>301/h1>h2 stylemargin-top:20px;font-size: 30px;>Moved Permanently/h2>p>The document has been permanently moved./p>/div>/div>/body>/html>
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mobile-grid-100 grid-100 tablet-grid-100 idprimary> main classsite-main idmain> article idpost-13 classpost-13 page type-page status-publish itemtypehttps://schema.org/CreativeWork itemscope> div classinside-article> div classentry-content itemproptext> div classgb-container gb-container-77172987>div classgb-container gb-container-2764df6d>div classwp-block-cover is-light videotest>video classwp-block-cover__video-background intrinsic-ignore autoplay muted loop playsinline srchttps://hf-insight.com/wp-content/uploads/2025/06/Video_van_Usability_Test.mp4 styleobject-position:47% 86% data-object-fitcover data-object-position47% 86%>/video>span aria-hiddentrue classwp-block-cover__background has-black-background-color has-background-dim>/span>div classwp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained>div classgb-container gb-container-396036cb inner>h1 classwp-block-heading has-base-3-color has-text-color has-link-color wp-elements-79814263a38e904d70695b9292061293>Medical human factors and usability consulting/h1>p classhas-base-3-color has-text-color has-link-color wp-elements-71010d47c27cb94a4efc8559f8378d04 stylefont-size:20px>We help medical device companies develop medical products that are safe, user-friendly, and regulatory-compliant.br>/p>div classwp-block-group is-nowrap is-layout-flex wp-container-core-group-is-layout-ad2f72ca wp-block-group-is-layout-flex>a classgb-button gb-button-42f76edb gb-button-text hrefhttps://hf-insight.com/human-factors-usability-services/ target_blank relnoopener noreferrer>View services/a>a classgb-button gb-button-a5357238 gb-button-text hrefhttps://hf-insight.com/contact/ target_blank relnoopener noreferrer>Request a quote/a>/div>/div>/div>/div>/div>/div>div classgb-container gb-container-3c599279 alignwide>div classgb-inside-container>h2 classwp-block-heading has-text-color stylecolor:#2aa2a3>How we help/h2>div classwp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex>div classwp-block-column is-layout-flow wp-block-column-is-layout-flow>figure classwp-block-image size-full is-resized>img fetchpriorityhigh decodingasync width512 height512 srchttps://hf-insight.com/wp-content/uploads/2020/06/research.png alt classwp-image-1465 styleobject-fit:cover;width:75px;height:75px srcsethttps://hf-insight.com/wp-content/uploads/2020/06/research.png 512w, https://hf-insight.com/wp-content/uploads/2020/06/research-300x300.png 300w, https://hf-insight.com/wp-content/uploads/2020/06/research-150x150.png 150w sizes(max-width: 512px) 100vw, 512px />/figure>p>/p>h3 classwp-block-heading>Medical usability testing/h3>p stylefont-size:17px>We focus exclusively on medical devices and have over a decade of experience conducting formative and summative usability testing./p>/div>div classwp-block-column is-layout-flow wp-block-column-is-layout-flow>figure classwp-block-image size-full is-resized>img decodingasync width512 height512 srchttps://hf-insight.com/wp-content/uploads/2020/06/checklist.png altRegulatory excellence with IEC 62366, FDA, MDR, and NMPA classwp-image-1462 styleobject-fit:cover;width:75px;height:75px srcsethttps://hf-insight.com/wp-content/uploads/2020/06/checklist.png 512w, https://hf-insight.com/wp-content/uploads/2020/06/checklist-300x300.png 300w, https://hf-insight.com/wp-content/uploads/2020/06/checklist-150x150.png 150w sizes(max-width: 512px) 100vw, 512px />/figure>p>/p>h3 classwp-block-heading>Regulatory experience/h3>p stylefont-size:17px>We have an in-depth understanding of the human factors and usability requirements for an MDR, FDA, or NMPA submission./p>/div>div classwp-block-column is-layout-flow wp-block-column-is-layout-flow>figure classwp-block-image size-full is-resized>img decodingasync width512 height512 srchttps://hf-insight.com/wp-content/uploads/2020/06/idea.png altAccessible human factors consulting services classwp-image-1122 stylewidth:75px srcsethttps://hf-insight.com/wp-content/uploads/2020/06/idea.png 512w, https://hf-insight.com/wp-content/uploads/2020/06/idea-300x300.png 300w, https://hf-insight.com/wp-content/uploads/2020/06/idea-150x150.png 150w sizes(max-width: 512px) 100vw, 512px />/figure>p>/p>h3 classwp-block-heading>Accessible service/h3>p stylefont-size:17px>We understand developing a medical device is a rigorous and costly process. Therefore, we provide transparent and accessible usability consulting services./p>/div>/div>/div>/div>div classgb-container gb-container-2382f5b1>div classgb-inside-container>h2 classwp-block-heading has-text-color stylecolor:#2aa2a3>Our services/h2>div classgb-grid-wrapper gb-grid-wrapper-f0ca07b4>div classgb-grid-column gb-grid-column-369569da>div classgb-container gb-container-369569da>figure classwp-block-image size-full is-resized medimage>img loadinglazy decodingasync width450 height311 srchttps://hf-insight.com/wp-content/uploads/2020/06/evaluation.jpg altA usability participant entering a tube in a simulated patient classwp-image-1675 stylewidth:577px;height:auto srcsethttps://hf-insight.com/wp-content/uploads/2020/06/evaluation.jpg 450w, https://hf-insight.com/wp-content/uploads/2020/06/evaluation-300x207.jpg 300w sizesauto, (max-width: 450px) 100vw, 450px />/figure>h3 classwp-block-heading>br>Usability testing/h3>p classhas-text-align-left contentblock stylefont-size:17px>Conduct an expert review, formative usability test, and a summative usability test to improve medical device design and meet FDA, MDR, and NMPA human factors requirements./p>ul classwp-block-list>li stylefont-size:17px>Formative usability test/li>li stylefont-size:17px>Design expert review/li>li stylefont-size:17px>Summative usability test/li>/ul>/div>/div>div classgb-grid-column gb-grid-column-387ee80f>div classgb-container gb-container-387ee80f>figure classwp-block-image size-full is-resized serviceimage>img loadinglazy decodingasync width450 height311 srchttps://hf-insight.com/wp-content/uploads/2020/06/analysis.jpg altA medical device displaying patient parameters classwp-image-1674 stylewidth:577px srcsethttps://hf-insight.com/wp-content/uploads/2020/06/analysis.jpg 450w, https://hf-insight.com/wp-content/uploads/2020/06/analysis-300x207.jpg 300w sizesauto, (max-width: 450px) 100vw, 450px />/figure>h3 classwp-block-heading>br>Risk analysis/h3>p classhas-text-align-left contentblock stylefont-size:17px>Conduct use-related risk management activities in compliance with ISO 14971 to identify, analyze, and mitigate use-related risks that could have a potential to cause harm./p>ul classwp-block-list>li>Task analysis/li>li stylefont-size:17px>Known problems analysis/li>li>Use-related risk analysis (URRA)/li>/ul>/div>/div>div classgb-grid-column gb-grid-column-18ea1ee8>div classgb-container gb-container-18ea1ee8>figure classwp-block-image size-large serviceimage>img loadinglazy decodingasync width1024 height683 srchttps://hf-insight.com/wp-content/uploads/2020/06/AdobeStock_41259227-1024x683.jpeg altA medical device user presses a button classwp-image-1385 srcsethttps://hf-insight.com/wp-content/uploads/2020/06/AdobeStock_41259227-1024x683.jpeg 1024w, https://hf-insight.com/wp-content/uploads/2020/06/AdobeStock_41259227-300x200.jpeg 300w, https://hf-insight.com/wp-content/uploads/2020/06/AdobeStock_41259227-768x512.jpeg 768w, https://hf-insight.com/wp-content/uploads/2020/06/AdobeStock_41259227-1536x1024.jpeg 1536w, https://hf-insight.com/wp-content/uploads/2020/06/AdobeStock_41259227-2048x1365.jpeg 2048w sizesauto, (max-width: 1024px) 100vw, 1024px />/figure>p>/p>h3 classwp-block-heading>Usability documentation/h3>p classhas-text-align-left contentblock stylefont-size:17px>Develop usability documentation to ensure compliance with regulatory standards and develop safe, effective, and user-friendly products. /p>ul classwp-block-list>li>Usability engineering plan/li>li>Use specification/li>li>User interface requirements/li>li>Human Factors Engineering (HFE) / Usability Engineering (UE) Report/li>/ul>/div>/div>/div>div classgb-container gb-container-f2b1305f alignwide>div classgb-container gb-container-1e980b40>a classgb-button gb-button-001b5a64 gb-button-text hrefhttps://hf-insight.com/human-factors-usability-services/ target_blank relnoopener noreferrer>View detailed services/a>/div>/div>/div>/div>div classgb-container gb-container-796aa0e1>div classgb-inside-container>h2 classwp-block-heading has-text-color stylecolor:#2aa2a3>About us/h2>div classwp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex>div classwp-block-column is-layout-flow wp-block-column-is-layout-flow styleflex-basis:80%>p stylefont-size:17px>Human Factors Insight specializes in global human factors and usability consulting services for the medical industry. Our mission is to make usability and human factors consulting more accessible for medical device companies of any size./p>pre classwp-block-verse>strong>Our mission is to make human factors and usability services accessible for medical device companies of any size/strong>/pre>p stylefont-size:17px>Our consulting services include global formative and summative usability testing, use-related risk analysis, and the development of regulatory-compliant human factors engineering (HFE) documentation. Thanks to our network, we can recruit patients, caregivers, and healthcare professionals on a global level./p>p stylefont-size:17px>We ensure full regulatory compliance with global human factors and risk management standards such as ANSI / AAMI / a hrefhttps://www.iso.org/standard/63179.html>IEC 62366/a>, a hrefhttps://www.iso.org/standard/72704.html>ISO 14971/a>, a hrefhttps://www.fda.gov/media/80481/download>FDA’s final guidance on Human Factors Engineering/a>, MDR, and NMPA./p>/div>div classwp-block-column is-layout-flow wp-block-column-is-layout-flow styleflex-basis:50%>figure classgb-block-image gb-block-image-45da1e13>img loadinglazy decodingasync width2054 height1852 classgb-image gb-image-45da1e13 srchttps://hf-insight.com/wp-content/uploads/2025/11/flat-design-illustration-of-a-usability-test-of-a-medical-device-including-a-moderator-and-participant-evaluating-a-medical-device.-Embed-soft-pastel-colors-and-the-color-2aa2a3-1.jpg alt titleflat design illustration of a usability test of a medical device including a moderator and participant evaluating a medical device. Embed soft pastel colors and the color #2aa2a3 srcsethttps://hf-insight.com/wp-content/uploads/2025/11/flat-design-illustration-of-a-usability-test-of-a-medical-device-including-a-moderator-and-participant-evaluating-a-medical-device.-Embed-soft-pastel-colors-and-the-color-2aa2a3-1.jpg 2054w, https://hf-insight.com/wp-content/uploads/2025/11/flat-design-illustration-of-a-usability-test-of-a-medical-device-including-a-moderator-and-participant-evaluating-a-medical-device.-Embed-soft-pastel-colors-and-the-color-2aa2a3-1-300x270.jpg 300w, https://hf-insight.com/wp-content/uploads/2025/11/flat-design-illustration-of-a-usability-test-of-a-medical-device-including-a-moderator-and-participant-evaluating-a-medical-device.-Embed-soft-pastel-colors-and-the-color-2aa2a3-1-1024x923.jpg 1024w, https://hf-insight.com/wp-content/uploads/2025/11/flat-design-illustration-of-a-usability-test-of-a-medical-device-including-a-moderator-and-participant-evaluating-a-medical-device.-Embed-soft-pastel-colors-and-the-color-2aa2a3-1-768x692.jpg 768w, https://hf-insight.com/wp-content/uploads/2025/11/flat-design-illustration-of-a-usability-test-of-a-medical-device-including-a-moderator-and-participant-evaluating-a-medical-device.-Embed-soft-pastel-colors-and-the-color-2aa2a3-1-1536x1385.jpg 1536w, https://hf-insight.com/wp-content/uploads/2025/11/flat-design-illustration-of-a-usability-test-of-a-medical-device-including-a-moderator-and-participant-evaluating-a-medical-device.-Embed-soft-pastel-colors-and-the-color-2aa2a3-1-2048x1847.jpg 2048w sizesauto, (max-width: 2054px) 100vw, 2054px />/figure>/div>/div>div classwp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex>div classwp-block-column is-layout-flow wp-block-column-is-layout-flow>/div>/div>/div>/div>div classgb-container gb-container-cb793e07>div classgb-inside-container>h2 classwp-block-heading has-text-color stylecolor:#2aa2a3>Testimonials/h2>p>/p>div classgb-grid-wrapper gb-grid-wrapper-6b990ec0>div classgb-grid-column gb-grid-column-4392db5e>div classgb-container gb-container-4392db5e>div classgb-inside-container>blockquote classwp-block-quote is-layout-flow wp-block-quote-is-layout-flow>p classhas-text-align-center stylefont-size:17px>“em>Human Factors Insight organized, managed, and conducted our summative usability test in the United States. They provided clear human factors guidance to ensure we met FDA regulatory expectations./em>“/p>/blockquote>p classhas-text-align-center contentblock stylefont-size:17px>Project Manager at Medical Device Startup/p>/div>/div>/div>div classgb-grid-column gb-grid-column-67ee0c87>div classgb-container gb-container-67ee0c87>div classgb-inside-container>blockquote classwp-block-quote is-layout-flow wp-block-quote-is-layout-flow>p classhas-text-align-center stylefont-size:17px>“em>Human Factors Insight supported us through numerous formative usability tests with a high level of professionalism and expertise. They were a reliable partner every step of the way./em>“br>/p>/blockquote>p classhas-text-align-center stylefont-size:17px>Regulatory Lead at Large Medical Device Company/p>/div>/div>/div>div classgb-grid-column gb-grid-column-ecd7e7c6>div classgb-container gb-container-ecd7e7c6>div classgb-inside-container>blockquote classwp-block-quote is-layout-flow wp-block-quote-is-layout-flow>p classhas-text-align-center stylefont-size:17px>“em>We contracted Human Factors Insight to support the full usability engineering process for our medical device. They delivered high-quality work and were significantly more cost-effective than other HFE consultancies./em>“/p>/blockquote>p classhas-text-align-center stylefont-size:18px>Project Manager at Medical Device Startup/p>/div>/div>/div>/div>/div>/div>div classgb-container gb-container-3b800d9d>div classgb-inside-container>h2 classwp-block-heading has-text-color stylecolor:#2aa2a3>Expertise/h2>p stylefont-size:17px>Human Factors Insight has experience in a wide variety of medical devices and complex systems, including but not limited to:/p>div classgb-grid-wrapper gb-grid-wrapper-c8a31364>div classgb-grid-column gb-grid-column-1e0118cb>div classgb-container gb-container-1e0118cb>div classgb-inside-container>ul stylefont-size:18px classwp-block-list expertiselist>li stylefont-size:17px>Auto-injectors (AI)/li>li stylefont-size:17px>Pre-filled syringes (PFS)/li>li stylefont-size:17px>Blood glucose monitors (BGM)/li>li stylefont-size:17px>Drug delivery inhalation devices/li>li stylefont-size:17px>Insulin patch pumps/li>li stylefont-size:17px>Software as a medical device (SaMD)/li>li stylefont-size:17px>Diagnostic imaging systems/li>li stylefont-size:17px>Hemodialysis systems/li>li stylefont-size:17px>Wearable monitoring device/li>/ul>/div>/div>/div>div classgb-grid-column gb-grid-column-8ce3c78c>div classgb-container gb-container-8ce3c78c>div classgb-inside-container>ul stylefont-size:18px classwp-block-list expertiselist>li stylefont-size:17px>Airway clearance systems/li>li stylefont-size:17px>Endoscopic systems/li>li stylefont-size:17px>Incontinence systems/li>li stylefont-size:17px>Preventive stroke treatment kits/li>li stylefont-size:17px>Laboratory immunosupressants kits/li>li stylefont-size:17px>Ostomy pouching systems/li>li stylefont-size:17px>Surgical instruments/li>li stylefont-size:17px>Operating room (OR) systems/li>/ul>/div>/div>/div>/div>/div>/div>div classgb-container gb-container-92a4b8ac>div classgb-inside-container>h2 classwp-block-heading has-text-color stylecolor:#2aa2a3>Insights/h2>ul classwp-block-latest-posts__list is-grid columns-3 has-dates wp-block-latest-posts>li>a classwp-block-latest-posts__post-title hrefhttps://hf-insight.com/key-requirements-for-a-medical-device-summative-usability-test/>Key requirements for a medical device summative usability test/a>time datetime2025-12-04T15:51:20+00:00 classwp-block-latest-posts__post-date>December 4, 2025/time>/li>li>div classwp-block-latest-posts__featured-image>img loadinglazy decodingasync width150 height150 srchttps://hf-insight.com/wp-content/uploads/2020/06/AdobeStock_240802486-150x150.jpg classattachment-thumbnail size-thumbnail wp-post-image altA formative usability participant is pressing a medical device button. stylemax-width:200px; />/div>a classwp-block-latest-posts__post-title hrefhttps://hf-insight.com/develop-safer-medical-devices-why-early-human-factors-integration-is-critical/>The benefits of early Human Factors Engineering (HFE) Integration In Medical Device Development/a>time datetime2025-05-28T16:17:57+00:00 classwp-block-latest-posts__post-date>May 28, 2025/time>/li>/ul>/div>/div>div classgb-container gb-container-5d9efa15>div classgb-container gb-container-7745fe08>div classgb-inside-container>h2 classwp-block-heading has-text-color stylecolor:#2aa2a3>Expertise/h2>h2 classwp-block-heading has-text-align-center has-base-3-color has-text-color has-link-color wp-elements-d5370f69ed4309b2fcaf44b90949dfe5>How can we help?/h2>div classgb-grid-wrapper gb-grid-wrapper-19758d4b>div classgb-grid-column gb-grid-column-ba67408a>div classgb-container gb-container-ba67408a>div classgb-container gb-container-86935668>a classgb-button gb-button-ae3c8def gb-button-text hrefhttps://hf-insight.com/contact/>Request a quote/a>/div>/div>/div>/div>/div>/div>/div>p>/p> /div> /div>/article> /main> /div> /div>/div>div classsite-footer> div idfooter-widgets classsite footer-widgets> div classfooter-widgets-container> div classinside-footer-widgets> div classfooter-widget-1 grid-parent grid-33 tablet-grid-50 mobile-grid-100> aside idtext-5 classwidget inner-padding widget_text> div classtextwidget>p>a hrefhttps://hf-insight.com/privacy-policy/>Privacy policy/a>/p>/div> /aside> /div> div classfooter-widget-2 grid-parent grid-33 tablet-grid-50 mobile-grid-100> aside idtext-4 classwidget inner-padding widget_text> div classtextwidget>p>© Human Factors Insight 2025/p>/div> /aside> /div> div classfooter-widget-3 grid-parent grid-33 tablet-grid-50 mobile-grid-100> aside idlsi_widget-6 classwidget inner-padding widget_lsi_widget>ul classlsi-social-icons icon-set-lsi_widget-6 styletext-align: center>li classlsi-social-linkedin>a class relnofollow noopener noreferrer titleLinkedIn aria-labelLinkedIn hrefhttp://linkedin.com/company/human-factors-insight target_blank>i classlsicon lsicon-linkedin>/i>/a>/li>/ul>/aside> /div> /div> /div> /div> footer classsite-info aria-labelSite itemtypehttps://schema.org/WPFooter itemscope> div classinside-site-info> div classcopyright-bar> span> /div> /div> /footer> /div>script typespeculationrules>{prefetch:{source:document,where:{and:{href_matches:/*},{not:{href_matches:/wp-*.php,/wp-admin/*,/wp-content/uploads/*,/wp-content/*,/wp-content/plugins/*,/wp-content/themes/generatepress/*,/*\\?(.+)}},{not:{selector_matches:arel~\nofollow\}},{not:{selector_matches:.no-prefetch, .no-prefetch a}}},eagerness:conservative}}/script>script idgenerate-a11y>!function(){use strict;if(querySelectorin document&&addEventListenerin window){var edocument.body;e.addEventListener(pointerdown,(function(){e.classList.add(using-mouse)}),{passive:!0}),e.addEventListener(keydown,(function(){e.classList.remove(using-mouse)}),{passive:!0})}}();/script>script srchttps://hf-insight.com/wp-content/plugins/gp-premium/menu-plus/functions/js/sticky.min.js?ver1.10.0 idgenerate-sticky-js>/script>script srchttps://hf-insight.com/wp-includes/js/dist/hooks.min.js?verdd5603f07f9220ed27f1 idwp-hooks-js>/script>script srchttps://hf-insight.com/wp-includes/js/dist/i18n.min.js?verc26c3dc7bed366793375 idwp-i18n-js>/script>script idwp-i18n-js-after>wp.i18n.setLocaleData( { text direction\u0004ltr: ltr } );//# sourceURLwp-i18n-js-after/script>script srchttps://hf-insight.com/wp-content/plugins/contact-form-7/includes/swv/js/index.js?ver6.1.4 idswv-js>/script>script idcontact-form-7-js-before>var wpcf7 { api: { root: https:\/\/hf-insight.com\/wp-json\/, namespace: contact-form-7\/v1 }, cached: 1};//# sourceURLcontact-form-7-js-before/script>script srchttps://hf-insight.com/wp-content/plugins/contact-form-7/includes/js/index.js?ver6.1.4 idcontact-form-7-js>/script>script idgenerate-menu-js-before>var generatepressMenu {toggleOpenedSubMenus:true,openSubMenuLabel:Open Sub-Menu,closeSubMenuLabel:Close Sub-Menu};//# sourceURLgenerate-menu-js-before/script>script srchttps://hf-insight.com/wp-content/themes/generatepress/assets/js/menu.min.js?ver3.6.0 idgenerate-menu-js>/script>script idwp-emoji-settings typeapplication/json>{baseUrl:https://s.w.org/images/core/emoji/17.0.2/72x72/,ext:.png,svgUrl:https://s.w.org/images/core/emoji/17.0.2/svg/,svgExt:.svg,source:{concatemoji:https://hf-insight.com/wp-includes/js/wp-emoji-release.min.js?ver6.9}}/script>script typemodule>/*! 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