https://qservegroup.com/whitepaper This is a section en Thu, 30 Jul 2026 13:06:52 GMT 2026-07-30T13:06:52Z en https://qservegroup.com/whitepaper/human-factors-in-medical-device-submissions <div class="hs-featured-image-wrapper"> <a href="https://qservegroup.com/whitepaper/human-factors-in-medical-device-submissions" title="" class="hs-featured-image-link"> <img src="https://qservegroup.com/hubfs/Website%20Banner-Jul-30-2026-01-06-41-9065-PM.png" alt="Human Factors in Medical Device Submissions" class="hs-featured-image" style="width:auto !important; max-width:50%; float:left; margin:0 15px 15px 0;"> </a> </div> <p>Two FDA guidance documents now govern human factors evidence for a medical device marketing submission. The 2016 guidance explains how to run the human factors engineering (HFE) process; the 2026 guidance sorts every submission into one of three HF Submission Categories, each carrying a different documentation burden. Read separately, the two invite confusion. Read as one system, they describe a single body of evidence viewed from three angles: submission, quality management system (QMS), and inspection.</p> <div class="hs-featured-image-wrapper"> <a href="https://qservegroup.com/whitepaper/human-factors-in-medical-device-submissions" title="" class="hs-featured-image-link"> <img src="https://qservegroup.com/hubfs/Website%20Banner-Jul-30-2026-01-06-41-9065-PM.png" alt="Human Factors in Medical Device Submissions" class="hs-featured-image" style="width:auto !important; max-width:50%; float:left; margin:0 15px 15px 0;"> </a> </div> <p>Two FDA guidance documents now govern human factors evidence for a medical device marketing submission. The 2016 guidance explains how to run the human factors engineering (HFE) process; the 2026 guidance sorts every submission into one of three HF Submission Categories, each carrying a different documentation burden. Read separately, the two invite confusion. Read as one system, they describe a single body of evidence viewed from three angles: submission, quality management system (QMS), and inspection.</p> <img src="https://track-eu1.hubspot.com/__ptq.gif?a=145725324&amp;k=14&amp;r=https%3A%2F%2Fqservegroup.com%2Fwhitepaper%2Fhuman-factors-in-medical-device-submissions&amp;bu=https%253A%252F%252Fqservegroup.com%252Fwhitepaper&amp;bvt=rss" alt="" width="1" height="1" style="min-height:1px!important;width:1px!important;border-width:0!important;margin-top:0!important;margin-bottom:0!important;margin-right:0!important;margin-left:0!important;padding-top:0!important;padding-bottom:0!important;padding-right:0!important;padding-left:0!important; "> function-Senior Consultant Thu, 30 Jul 2026 13:06:52 GMT https://qservegroup.com/whitepaper/human-factors-in-medical-device-submissions 2026-07-30T13:06:52Z Tim Joiner