{"id":8211,"date":"2024-01-12T18:29:56","date_gmt":"2024-01-12T18:29:56","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8211"},"modified":"2024-01-12T19:05:46","modified_gmt":"2024-01-12T19:05:46","slug":"iso-14971-risk-management-basics","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/iso-14971-risk-management-basics\/","title":{"rendered":"ISO 14971 and the Basics of Medical Device Risk Management Explained"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8211\" class=\"elementor elementor-8211\" 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\">ISO 14971 and the Basics of Medical Device Risk Management Explained\n<\/h1>\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<div class=\"box-cur\">This is the first installment of a 3-part blog series on risk management. If you already know the basics, skip to the second post on\u00a0<strong><a href=\"https:\/\/www.orielstat.com\/blog\/medical-device-risk-management-plan\/\">risk management planning<\/a><\/strong>. We&#8217;ve combined all three posts into one easy-to-read PDF, plus added some extras. <strong><a href=\"https:\/\/www.orielstat.com\/Medical-Device-Risk-Management-101\" target=\"_blank\" rel=\"noopener noreferrer\">Download it here.<\/a><\/strong><\/div><p>From a distance, risk management seems straightforward. You have a device, evaluate its potential risks, mitigate those risks, monitor them over time, and you are done. Seems easy, right? Ah, if only life were so straightforward. The reality is that risk management is one of the more complex aspects of regulatory compliance, simply because risk comes in so many flavors and perceptions of severity, and probability can be interpreted quite differently.<\/p><p>The thing that makes risk management tricky is that we often don&#8217;t have enough real-world data to accurately quantify risks, especially for new devices. Fortunately, there is a systematic process you can establish to estimate, evaluate, control, and monitor risks. Before we get into that, let&#8217;s step back and talk about the regulations and standards that dictate how you should approach risk management.<\/p><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"size-medium wp-image-966 aligncenter lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-297x300.png\" sizes=\"(max-width: 297px) 100vw, 297px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-297x300.png 297w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-90x90.png 90w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-75x75.png 75w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72.png 321w\" alt=\"Risk Management Cycle\" width=\"297\" height=\"300\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-297x300.png\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-297x300.png 297w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-90x90.png 90w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-75x75.png 75w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72.png 321w\" data-sizes=\"(max-width: 297px) 100vw, 297px\" data-was-processed=\"true\" \/><\/p><h4>\u00a0<\/h4><h3>Medical device risk and risk management defined<\/h3><ul><li><strong><em>Risk<\/em><\/strong>\u00a0is the combination of probability of occurrence of harm and the severity of that harm.<\/li><li><strong><em>Risk management<\/em><\/strong>\u00a0is the systematic application of management policies, procedures, and practices to the tasks of analyzing, controlling, and monitoring risk.<\/li><\/ul><h4>\u00a0<\/h4><h3>Why is risk management needed?<\/h3><p>Simply put, we have a collective interest in ensuring that medical devices are safe and effective. Risk management is not optional it is a regulatory requirement worldwide. The US FDA mandates it in the Quality System Regulation (21 CFR Part 820). Europe requires it in the new Medical Device Regulation (MDR 2017\/745). Likewise, Japan, Canada, Australia, Brazil, and all other major markets require the application of risk management, which is either referenced in their national regulations and\/or ISO 13485:2016.<\/p><p>\u00a0<\/p><h3>The role of the ISO 14971 standard<\/h3><p>Fortunately, national governments have NOT created their own guidelines telling you how to how to perform risk management. Instead, they all defer to ISO 14971, the global standard for medical device risk management. The intent of the standard is to identify hazards associated with medical devices at all stages in its life cycle, from product design to procurement to production and postmarket use. In all cases, the goal is to estimate, evaluate, control, and monitor the risks associated with each life-cycle stage. There are two versions of this standard in use today:<\/p><ul><li><strong>ISO 14971:2007<\/strong>\u00a0The US FDA and most other markets recommend this version of the standard to meet national risk management requirements.<\/li><li><strong>ISO 14971:2012<\/strong>\u00a0This version is required to meet CE Marking requirements for medical devices sold in Europe. It differs only the front matter describing how ISO 14971:2007 deviates from the device directives in Europe.<\/li><\/ul><p>If you are just getting started implementing risk management for your company, purchase the ISO 14971:2012 standard and its guidance ISO 24971:2013. You will also want to buy and read the ISO\/TR 24971:2013 standard. It is brief but provides excellent guidance for dealing with specific areas of ISO 14971. Both are copyrighted documents and you can purchase them online from\u00a0<a href=\"https:\/\/www.iso.org\/standard\/59587.html\" target=\"_blank\" rel=\"noopener noreferrer\">ISO<\/a>.<\/p><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter wp-image-959 size-large lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/ISO-14971-years-Flow-BLOG-72-1024x267.png\" sizes=\"(max-width: 860px) 100vw, 860px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/ISO-14971-years-Flow-BLOG-72-1024x267.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/ISO-14971-years-Flow-BLOG-72-300x78.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/ISO-14971-years-Flow-BLOG-72-768x200.png 768w\" alt=\"ISO 14971 Timeline\" width=\"860\" height=\"224\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/ISO-14971-years-Flow-BLOG-72-1024x267.png\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/ISO-14971-years-Flow-BLOG-72-1024x267.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/ISO-14971-years-Flow-BLOG-72-300x78.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/ISO-14971-years-Flow-BLOG-72-768x200.png 768w\" data-sizes=\"(max-width: 860px) 100vw, 860px\" data-was-processed=\"true\" \/><\/p><p><em>ISO 14971 was first introduced in 1998 and has expanded in scope during subsequent releases. Work on an updated version is\u00a0<\/em><em>underway<\/em><em>.<\/em><\/p><p><em><strong>An updated dated ISO 14971 is underway and expected to be complete sometime in 2019.<\/strong>\u00a0The focus of the revision is not on revising the risk management process but rather to improve the information on implementation of the life cycle risk management process.<\/em><\/p><h3>\u00a0<\/h3><h3>Sections of ISO 14971<\/h3><p>Although risk management can be complex, the main body of the ISO 14971 standard is a scant 14 pages and consists of 9 clauses:<\/p><ol><li>Scope<\/li><li>Terms and conditions<\/li><li>General requirements for risk management<\/li><li>Risk analysis<\/li><li>Risk evaluation<\/li><li>Risk control<\/li><li>Evaluation of overall risk acceptability<\/li><li>Risk management report<\/li><li>Production and post-production information<\/li><\/ol><p>And these are the key annexes supporting those clauses:<\/p><ul><li><strong>Annex A<\/strong>\u00a0Rationale for requirements<\/li><li><strong>Annex B\u00a0<\/strong>Overview of risk management process for medical devices<\/li><li><strong>Annex C\u00a0<\/strong>Questions that can be used to identify medical device characteristics that could impact safety<\/li><li><strong>Annex D\u00a0<\/strong>Risk concepts applied to medical devices<\/li><li><strong>Annex E\u00a0<\/strong>Examples of hazards, foreseeable sequences of events, and hazardous situations<\/li><li><strong>Annex F\u00a0<\/strong>Risk management plan<\/li><li><strong>Annex G\u00a0<\/strong>Information on risk management techniques<\/li><li><strong>Annex H\u00a0<\/strong>Guidance on risk management for in-vitro diagnostic medical devices<\/li><li><strong>Annex I\u00a0<\/strong>Guidance on risk analysis process for biological hazards<\/li><li><strong>Annex J\u00a0<\/strong>Information for safety and information about residual risk<\/li><\/ul><h3>\u00a0<\/h3><h3>Basic steps in the medical device risk management process<\/h3><p>So where to begin? It helps to think about risk management as a process that starts with a plan. While the end deliverable is a report, your work in controlling risk is never done. We will talk in detail about each of these areas later, but here are the steps.<\/p><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-2964 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/05\/Steps-in-risk-management-e1592855686507.png\" alt=\"Risk Management Steps - ISO 14971:2019\" width=\"661\" height=\"419\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/05\/Steps-in-risk-management-e1592855686507.png 661w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/05\/Steps-in-risk-management-e1592855686507-300x190.png 300w\" sizes=\"(max-width: 661px) 100vw, 661px\" \/><\/p><p>\u00a0<\/p><ul><li><strong>Create a risk management plan<\/strong>: Document activities that will take place, assign responsibilities, determine risk review requirements, establish risk acceptability levels, plan verification activities, and plan production\/post-production activities.<\/li><li><strong>Assemble your risk management team<\/strong>: Assemble a qualified team of people who know how your device is constructed, its manufacturing processes, how it is used in the field, etc.<\/li><li><strong>Use risk analysis tools to identify risks<\/strong>: Choose the tools you will use to measure risk (discussed more later) and then use them to identity risks posed by your processes, users, suppliers, maintenance tasks, shipping, production equipment, etc.<\/li><li><strong>Weigh the risks versus the benefits<\/strong>: This is fairly self-explanatory, but the end goal is to ensure that the medical benefits of your device outweigh residual risks.<\/li><li><strong>Eliminate or mitigate risks<\/strong>: The goal here is to reduce risks to an acceptable level. Well talk more about risk reduction later and address how this varies between the 2007 and 2012 versions of ISO 14971.<\/li><\/ul><p>\u00a0<\/p><h3>Want to learn more?<\/h3><p>If you enjoyed this article, be sure to read the\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/medical-device-risk-management-plan\/\" target=\"_blank\" rel=\"noopener noreferrer\">second post<\/a> in this series focusing on risk management planning. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>ISO 14971 and the Basics of Medical Device Risk Management Explained This is the first installment of a 3-part blog series on risk management. If you already know the basics, skip to the second post on\u00a0risk management planning. We&#8217;ve combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. From [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[30],"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\/iso-14971-risk-management-basics\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"ISO 14971 and the Basics of Medical Device Risk Management Explained This is the first installment of a 3-part blog series on risk management. If you already know the basics, skip to the second post on\u00a0risk management planning. We&#8217;ve combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. From [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/iso-14971-risk-management-basics\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2024-01-12T18:29:56+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-12T19:05:46+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-297x300.png\" \/>\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=\"7 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\/iso-14971-risk-management-basics\/","og_locale":"en_US","og_type":"article","og_description":"ISO 14971 and the Basics of Medical Device Risk Management Explained This is the first installment of a 3-part blog series on risk management. If you already know the basics, skip to the second post on\u00a0risk management planning. We&#8217;ve combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. From [&hellip;]","og_url":"https:\/\/www.orielstat.com\/blog\/iso-14971-risk-management-basics\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2024-01-12T18:29:56+00:00","article_modified_time":"2024-01-12T19:05:46+00:00","og_image":[{"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/09\/Risk-Management-Cycle-02-BLOG-72-297x300.png"}],"author":"usr192162","twitter_card":"summary_large_image","twitter_misc":{"Written by":"usr192162","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/iso-14971-risk-management-basics\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/iso-14971-risk-management-basics\/"},"author":{"name":"usr192162","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553"},"headline":"ISO 14971 and the Basics of Medical Device Risk Management Explained","datePublished":"2024-01-12T18:29:56+00:00","dateModified":"2024-01-12T19:05:46+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/iso-14971-risk-management-basics\/"},"wordCount":1021,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["ISO 14971 Risk Management"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/iso-14971-risk-management-basics\/","url":"https:\/\/www.orielstat.com\/blog\/iso-14971-risk-management-basics\/","name":"","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2024-01-12T18:29:56+00:00","dateModified":"2024-01-12T19:05:46+00:00","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/iso-14971-risk-management-basics\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.orielstat.com\/blog\/#website","url":"https:\/\/www.orielstat.com\/blog\/","name":"Oriel STAT A MATRIX Blog","description":"","publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.orielstat.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.orielstat.com\/blog\/#organization","name":"Oriel STAT A MATRIX Blog","url":"https:\/\/www.orielstat.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","contentUrl":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","width":1458,"height":1042,"caption":"Oriel STAT A MATRIX Blog"},"image":{"@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553","name":"usr192162","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","caption":"usr192162"},"url":"https:\/\/www.orielstat.com\/blog\/author\/usr192162\/"}]}},"_links":{"self":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8211"}],"collection":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/comments?post=8211"}],"version-history":[{"count":8,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8211\/revisions"}],"predecessor-version":[{"id":8228,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8211\/revisions\/8228"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=8211"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=8211"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=8211"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}