{"id":6698,"date":"2026-06-05T12:24:48","date_gmt":"2026-06-05T06:54:48","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6698"},"modified":"2026-06-05T12:24:48","modified_gmt":"2026-06-05T06:54:48","slug":"risk-benefit-analysis-in-medical-devices","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/de-en\/risk-benefit-analysis-in-medical-devices\/","title":{"rendered":"Benefit-Risk Analysis in Medical Devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6698\" class=\"elementor elementor-6698\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-59f5913b e-flex e-con-boxed e-con e-parent\" data-id=\"59f5913b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1ae0e879 elementor-widget elementor-widget-heading\" data-id=\"1ae0e879\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Benefit-Risk Analysis in Medical Devices<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-59e3861 e-flex e-con-boxed e-con e-parent\" data-id=\"59e3861\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8690d71 e-con-full e-flex e-con e-child\" data-id=\"8690d71\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1b4bfa17 elementor-widget elementor-widget-text-editor\" data-id=\"1b4bfa17\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">ISO 14971 <\/span><span style=\"font-weight: 400;\">requires medical device manufacturers to conduct a benefit-risk analysis of their devices as part of the certification process. As a result, this page educates readers on what BRA is, how to assess the advantages and hazards of a medical device, and which guidelines to follow.<\/span><\/p><h2><span style=\"font-weight: 400;\">Benefit-Risk Analysis<\/span><\/h2><p><span style=\"font-weight: 400;\">Benefit-risk analysis is not an option. ISO 14971 requires this. It assists a manufacturer in determining whether the advantages of a medical device outweigh the hazards.<\/span><\/p><p><span style=\"font-weight: 400;\">It is critical to understand that the advantages and hazards are typically not of the same magnitude. As a result, objectively balancing the rewards and hazards is sometimes difficult, if not impossible. It\u2019s like comparing apples to mandarins.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6a47af10 e-con-full e-flex e-con e-child\" data-id=\"6a47af10\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-69d80029 e-con-full e-flex e-con e-child\" data-id=\"69d80029\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f532574 elementor-widget elementor-widget-heading\" data-id=\"f532574\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Talk to our experts!<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34cde7d8 elementor-widget elementor-widget-wpforms\" data-id=\"34cde7d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/de-en\/wp-json\/wp\/v2\/posts\/6698\" data-token=\"a9cf6cd8d4000495d77213cf2045c3d0\" data-token-time=\"1780657005\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\">\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Email Text Name<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/posts\/6698\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-71ea3e2f e-flex e-con-boxed e-con e-parent\" data-id=\"71ea3e2f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-26da0a27 elementor-widget elementor-widget-heading\" data-id=\"26da0a27\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Elements for evaluating the benefits of a Medical Device:\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-46b64c46 elementor-widget elementor-widget-text-editor\" data-id=\"46b64c46\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The benefits of a medical device are presumed if it functions reliably and as planned. A device\u2019s benefits are normally determined via a clinical evaluation performed by the manufacturer. However, non-clinical assessments, such as usability testing, computer modeling and simulations, and cell-based testing, can be utilized to determine the benefits of a medical device.<\/span><\/p><p><span style=\"font-weight: 400;\">To assess the benefits of a medical device, a producer must consider many aspects. Namely:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Type of the benefit (e.g., enhancing quality of life, relieving symptoms, and assisting in the improvement of patient function)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The magnitude of the benefit: This is typically assessed against a scale based on specified criteria.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Benefit probability: This shows the likelihood that a patient would receive the intended benefit, which does not apply to all patients.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Duration of benefit: How long does the intended benefit last?\u00a0\u00a0<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ea90b84 elementor-widget elementor-widget-heading\" data-id=\"ea90b84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Elements for Evaluating the Risk of a Medical Device:\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f2b2faa elementor-widget elementor-widget-text-editor\" data-id=\"f2b2faa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Along with the variables listed above, a manufacturer must consider several additional factors when weighing the risks and advantages of a medical device. Namely:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical data quality: Poorly designed and conducted clinical studies may render clinical outcomes untrustworthy, undermining the assertion that benefits outweigh dangers.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The illness features are: Is the disease degenerative or stable? Does the condition worsen over time if not treated?<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Patient\u2019s risk tolerance: The patient\u2019s risk tolerance is highly dependent on the severity of the disease. Patients with life-threatening conditions, for example, may be willing to take on greater risk.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">In terms of the last point, if a device delivers a tiny benefit for an illness for which no alternative therapy exists, it may nevertheless be approved. However, a higher-risk device may be licensed for commercial use if it is more effective for a subset of patients or under specific conditions (for example, in tropical regions).<\/span><\/p><p><span style=\"font-weight: 400;\">A manufacturer can use the figure below to visually demonstrate the acceptability of the benefit-to-risk ratio. The term \u201cstate-of-the-art\u201d (SOTA) refers to medical equipment that has acquired market approval and is now in use. SOTA could refer to your own gadget or a competitor\u2019s device. The graphic contains four quadrants, which can be described as follows:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Upper-left quadrant: If the studied device provides more benefit for the same or lower risk, the benefit-to-risk ratio improves, and the benefits outweigh the dangers.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Lower-right quadrant: If the studied device provides less benefit for the same or higher risk, the benefit does not justify the danger.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Upper-right and lower-left quadrants: Additional investigation is required to establish whether the benefits exceed the dangers.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Finally, a benefit-risk analysis should be conducted for the entire target group. This is because certain members of the target demographic may find the benefit-risk ratio acceptable.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f72c6d0 elementor-widget elementor-widget-heading\" data-id=\"f72c6d0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">CE and FDA Criteria for Benefit-Risk Analysis\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b44800 elementor-widget elementor-widget-text-editor\" data-id=\"3b44800\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Medical device producers who want to commercialize their products in the United States must get FDA approval. To achieve this, they must use the following guideline materials to conduct the benefit-risk analysis:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Factors to Consider When Making Benefit-Risk Decisions in MD Premarket Approval and De Novo Classifications \u2013 FDA Guidance Document<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Benefit-Risk Factors to Consider When Establishing Substantial Equivalence in Premarket Notifications with Different Technological Characteristics (download FDA guidance PDF)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Factors to Consider When Making Benefit-Risk Determinations for Medical Device IDEs (FDA guidance document)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions\u2014FDA guideline paper<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Unpredictability in Making Benefit-Risk Determinations in MD Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions (FDA guidance document)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Delivering periodic benefit-risk evaluation reports \u2013 FDA guidance document<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">E2C(R2) Periodic Benefit-Risk Evaluation Report: Questions &amp; Answers \u2013 <\/span><span style=\"font-weight: 400;\">FDA<\/span><span style=\"font-weight: 400;\"> guidance paper.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">E2C(R2) Periodic Benefit-Risk Evaluation Report \u2013 An FDA recommendation paper.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">However, the above documents are useless for gaining access to the European Union market. To pass the<\/span><span style=\"font-weight: 400;\"> CE marking <\/span><span style=\"font-weight: 400;\">process, manufacturers must follow Annex XIV of the EU MDR 2017\/745 or Annexes XIII and XIV of the EU IVDR 2017\/746. Furthermore, the following advice documents can be utilized to do a benefit-risk analysis.<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical Evaluation: Equivalence. A handbook for manufacturers and notified entities. <\/span><span style=\"font-weight: 400;\">EU MDR<\/span><span style=\"font-weight: 400;\"> 2017\/745, MDCG 2020-5<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Regulation (EU) 2017\/745: Clinical evidence required for medical devices formerly CE approved under MDD 93\/42\/EEC or AIMDD 90\/385\/EEC (MDCG 2020-6).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMCF Plan Template: MDCG 2020-7<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMCF Evaluation Report Template (MDCG 2020-8)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">MDCG 2019-9: Summary of Safety and Clinical Performance.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Safety reporting in clinical investigations of medical devices under the EU MDR 2017\/745-MDCG 2020-10-1<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Safety reporting in clinical trials (MDCG 2020-10-2)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical evaluation assessment report template for MDCG 2020-13.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">We help you in the process of making a defined and comprehensive technical file with all product details required for <\/span><a href=\"https:\/\/operonstrategist.com\/ce-mark-vs-fda-approval-for-medical-devices\/\"><span style=\"font-weight: 400;\">CE marking and FDA<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p><p><a href=\"https:\/\/www.operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">Contact Us on WhatsApp<\/span><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0199198 elementor-widget elementor-widget-heading\" data-id=\"0199198\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Benefit-Risk Analysis for Clinical Evaluations\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-647a781 elementor-widget elementor-widget-text-editor\" data-id=\"647a781\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">During a clinical examination, the medical device may not be licensed for commercial usage. This is because it may not benefit patients while still posing safety risks to clinical research participants. However, the device\u2019s benefit-risk profile must be examined and demonstrated to be appropriate for the chosen research population before the clinical evaluation may commence.<\/span><\/p><p><span style=\"font-weight: 400;\">The benefit-risk analysis for clinical evaluations must include the following elements:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical background includes information about the clinical condition to be treated, managed, or diagnosed, as well as the ailment\u2019s prevalence and natural progression.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Alternative medical gadgets are currently available to the target audience. The following information should be provided: previous treatments, available medical choices (conservative, surgical, medicinal), and existing technologies.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Further, when determining the acceptability of risks, producers should evaluate inadequacies in current medicines to determine whether their technology fills a significant gap in already accessible healthcare. If the gap is not considerable, the device\u2019s benefit-risk profile should be superior to that of current goods and therapies.\u00a0\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Operon Strategist is Your Partner for <a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\">CE Marking<\/a>, <a href=\"https:\/\/operonstrategist.com\/elevateplus\/us-fda-510k-qsmr-registration\/\">FDA 510(k)<\/a>, Medical Device Registration, and ISO Compliance\u2014<\/span><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">Reach Out<\/span><\/a><span style=\"font-weight: 400;\"> and Elevate Your Success Today!<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>ISO 14971 requires medical device manufacturers to conduct a benefit-risk analysis of their devices as part of the certification process. As a result, this page educates readers on what BRA is, how to assess the advantages and hazards of a medical device, and which guidelines to follow. Benefit-Risk Analysis Benefit-risk analysis is not an option. [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":9429,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6698","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/posts\/6698","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/comments?post=6698"}],"version-history":[{"count":4,"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/posts\/6698\/revisions"}],"predecessor-version":[{"id":9430,"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/posts\/6698\/revisions\/9430"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/media\/9429"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/media?parent=6698"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/categories?post=6698"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/de-en\/wp-json\/wp\/v2\/tags?post=6698"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}