{"id":4159,"date":"2015-02-27T23:15:35","date_gmt":"2015-02-27T23:15:35","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4159"},"modified":"2015-02-27T23:15:35","modified_gmt":"2015-02-27T23:15:35","slug":"bsi-white-paper-on-human-factors-usability","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2015\/02\/27\/bsi-white-paper-on-human-factors-usability\/","title":{"rendered":"BSI White Paper on Human Factors &#038; Usability"},"content":{"rendered":"<p><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2015\/02\/bsi-hfusability-wp-cover.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-medium wp-image-4160\" style=\"margin-top: 2px; margin-bottom: 2px;\" title=\"bsi hf&amp;usability wp cover\" src=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2015\/02\/bsi-hfusability-wp-cover-212x300.jpg\" alt=\"\" width=\"212\" height=\"300\" \/><\/a><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Blog focus BSI\u2019s 7<sup>th<\/sup>\u00a0in a series of White Papers for Medical Device, on \u00a0Human Factors &amp; Usability Engineering<\/span><\/p>\n<p><strong><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">White Paper on\u00a0The growing role of human factors and usability engineering for medical devices<\/span><\/strong><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">This white paper is on \u201c<a href=\"http:\/\/www.bsigroup.com\/en-GB\/our-services\/medical-device-services\/BSI-Medical-Devices-Whitepapers\/\" target=\"_blank\" rel=\"noopener noreferrer\">The growing role of human factors and usability engineering for medical devices\u201d<\/a>and is focused on \u201c&#8230;applying knowledge of human capabilities and limitations Human Factors and Usability Engineering (HF\/UE) contributes to the design of intuitive displays, controls, and other interfaces that substantially reduce the risk of user error.\u201d \u00a0It is written by Bob North, Human Centered Strategies.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.<\/span><\/p>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"><strong>White Paper Series\u00a0<\/strong><\/span><strong><\/strong><\/h2>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">This is the last planned white paper in this series of white papers. \u00a0BSI said of the series that &#8220;&#8230;we are&#8230;producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.\u201d<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The other white papers in the series you may be interested in reading, as they are very timely and current, are below:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Negotiating the innovation and regulatory conundrum<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Engaging stakeholders in the home medical device market<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">What you need to know about the FDA&#8217;s UDI system final rule<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Effective post-market surveillance; Understanding and conducting vigilance and post-market clinical follow-up<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and consequences for the market<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Generating clinical evaluation reports: A guide to effectively analysing medical device safety and performance<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong><a href=\"http:\/\/www.bsigroup.com\/en-GB\/our-services\/medical-device-services\/BSI-Medical-Devices-Whitepapers\/\" target=\"_blank\" rel=\"noopener noreferrer\">You can sign-up for future white papers<\/a><\/strong>\u00a0or <strong><a href=\"http:\/\/shop.bsigroup.com\/upload\/forms\/newsletter-signup.html\" target=\"_blank\" rel=\"noopener noreferrer\">sign-up for their industry sectors newsletter<\/a><\/strong>.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers or preparing for your Notified Body Audit, email Leo Eisner directly at\u00a0<strong><a href=\"mailto:Leo@EisnerSafety.com\">Leo@EisnerSafety.com<\/a><\/strong>, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (<strong><a title=\"Link to Eisner Safety Consultants Website\" href=\"http:\/\/bit.ly\/EisnerSafetyConsultants\">bit.ly\/EisnerSafetyConsultants<\/a><\/strong>).<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Blog focus BSI\u2019s 7th\u00a0in a series of White Papers for Medical Device, on \u00a0Human Factors &amp; Usability Engineering White Paper on\u00a0The growing role of human factors and usability engineering for medical devices This white paper is on \u201cThe growing role<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[1171,173,840,27,1172,1211,17,335,1173,12,1174,22,330,266,174,175,149,32,1212,289,1045,341],"class_list":["post-4159","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-bsi","tag-esc","tag-esc-news","tag-escnews","tag-eu-regulation","tag-hfe","tag-human-factors","tag-human-factors-engineering","tag-ivdr","tag-mdd","tag-mdr","tag-medical","tag-medical-device","tag-medical-device-directive","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-notified-body","tag-ue","tag-usability","tag-usability-analysis","tag-usability-engineering"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4159","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=4159"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4159\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=4159"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=4159"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=4159"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}