{"id":6898,"date":"2026-06-04T15:15:33","date_gmt":"2026-06-04T09:45:33","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6898"},"modified":"2026-06-04T15:15:33","modified_gmt":"2026-06-04T09:45:33","slug":"mastering-psur-compliance-for-medical-devices","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/dz-en\/mastering-psur-compliance-for-medical-devices\/","title":{"rendered":"Guide to Post-Market Surveillance for Medical Devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6898\" class=\"elementor elementor-6898\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5932c141 e-flex e-con-boxed e-con e-parent\" data-id=\"5932c141\" 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-7a8e0ce6 elementor-widget elementor-widget-heading\" data-id=\"7a8e0ce6\" 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\">Guide to Post-Market Surveillance for Medical Devices<\/h2>\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-7b9d92de e-flex e-con-boxed e-con e-parent\" data-id=\"7b9d92de\" 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-beac51d e-con-full e-flex e-con e-child\" data-id=\"beac51d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-66a272a4 elementor-widget elementor-widget-heading\" data-id=\"66a272a4\" 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\">What is a Periodic Safety Update Report (PSUR) for Medical Devices?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-623140d9 elementor-widget elementor-widget-text-editor\" data-id=\"623140d9\" 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;\">In the evolving regulatory landscape of medical devices, maintaining post-market vigilance is paramount. Among the essential elements of this framework is the <\/span><a href=\"https:\/\/operonstrategist.com\/periodic-safety-update-report-psur\/\"><span style=\"font-weight: 400;\">Periodic Safety Update Report (PSUR)<\/span><\/a><span style=\"font-weight: 400;\">, a critical requirement outlined under the European Union\u2019s Medical Device Regulation (MDR). This report ensures ongoing safety and compliance while fostering transparency and accountability among manufacturers. <\/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-3d27a5fb e-con-full e-flex e-con e-child\" data-id=\"3d27a5fb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-33a28353 e-con-full e-flex e-con e-child\" data-id=\"33a28353\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3877e234 elementor-widget elementor-widget-heading\" data-id=\"3877e234\" 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-7f4e0a4e elementor-widget elementor-widget-wpforms\" data-id=\"7f4e0a4e\" 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=\"\/dz-en\/wp-json\/wp\/v2\/posts\/6898\" data-token=\"947330bc31d331298c2701c8bb1074b8\" data-token-time=\"1780591136\"><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\"><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>\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\" >Name Text Email<\/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_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; 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It is essentially a periodic summary that consolidates the outcomes of post-market surveillance activities and the corresponding conclusions drawn by the manufacturer. These include corrective or preventive actions (<\/span><a href=\"https:\/\/operonstrategist.com\/capa-corrective-action-and-preventive-action\/\"><span style=\"font-weight: 400;\">CAPAs<\/span><\/a><span style=\"font-weight: 400;\">) taken, with detailed descriptions and rationales. The PSUR serves as a mechanism to assure regulators and stakeholders that the medical device remains safe and effective throughout its lifecycle. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb94f12 elementor-widget elementor-widget-heading\" data-id=\"bb94f12\" 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\">Add Your Heading Text HWho Needs to Prepare a PSUR?ere<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8256a32 elementor-widget elementor-widget-text-editor\" data-id=\"8256a32\" 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;\">Under Article 86 of the MDR, the PSUR is mandatory for specific categories of devices, ensuring compliance with stringent safety standards. These include:\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">MDR-compliant devices of Class IIa, IIb, and III.\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Custom-made devices are falling under the higher risk categories.\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Annex XVI devices classified as IIa, IIb, or III.\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Legacy devices under MDR, following the transition from previous directives like MDD and AIMDD.\u00a0<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Manufacturers of these devices must update and maintain PSURs as per their classification and make them available to Notified Bodies and competent authorities as required.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Exceptions:\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Class I devices (both legacy and MDR-compliant) are not required to have a PSUR. Instead, they must prepare a <\/span><a href=\"https:\/\/operonstrategist.com\/post-market-surveillance-for-medical-devices\/\"><span style=\"font-weight: 400;\">Post-Market Surveillance (PMS) Report<\/span><\/a><span style=\"font-weight: 400;\">, which is updated as necessary. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9d85ba elementor-widget elementor-widget-heading\" data-id=\"f9d85ba\" 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\">9 Key Rules for PSUR Compliance\n<\/h2>\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-385724a1 e-con-full e-flex e-con e-child\" data-id=\"385724a1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c0a7f80 elementor-widget elementor-widget-text-editor\" data-id=\"c0a7f80\" 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;\">To ensure regulatory alignment, manufacturers must adhere to the following nine rules:\u00a0<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Organized Data Representation: Clearly present data for each Basic UDI-DI.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u201cLeading Device\u201d Designation: Assign a leading device from the highest risk class to guide the PSUR schedule.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Unified Schedule: The leading device dictates the PSUR timeline for the entire group.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Consistency in Requirements: Match PSUR requirements for all devices in the group with those of the leading device.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Device Group Modifications: Device groupings in a PSUR can be adjusted, except for the leading device.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Updates for Changes: Issue a new PSUR for any change in the leading device.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Continued Updates: Keep updating PSURs for groups with former leading devices.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Uniform Review Process: Group devices in a PSUR only if reviewed by the same Notified Body.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cross-Notified Body Actions: Include actions and references from previous PSURs when devices are assessed by different Notified Bodies.\u00a0<\/span><\/li><\/ol><p><span style=\"font-weight: 400;\">By following these guidelines, manufacturers can demonstrate compliance and facilitate seamless surveillance audits. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cc860d8 elementor-widget elementor-widget-heading\" data-id=\"cc860d8\" 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\">Role Of Operon Strategist\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6b53649 elementor-widget elementor-widget-text-editor\" data-id=\"6b53649\" 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;\">As a trusted name in regulatory consulting, Operon Strategist plays a pivotal role in helping manufacturers navigate the complexities of PSUR preparation and compliance.\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Expert Guidance: Operon Strategist ensures clarity in understanding and implementing the MDR requirements, reducing the burden on manufacturers.\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Streamlined Processes: The team assists in organizing and presenting PSUR data effectively, adhering to all nine compliance rules.\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Risk Mitigation: With Operon\u2019s strategic support, manufacturers can proactively address compliance gaps and minimize regulatory risks.\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Comprehensive Solutions: Operon\u2019s expertise extends across a wide range of devices, offering tailored solutions for both legacy and MDR-compliant products.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Operon Strategist delivers complete solutions for obtaining <\/span><a href=\"https:\/\/operonstrategist.com\/services\/\"><span style=\"font-weight: 400;\">regulatory approvals<\/span><\/a><span style=\"font-weight: 400;\">, including <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\">European CE Marking<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/fda-510k\/\"><span style=\"font-weight: 400;\">FDA 510(k)<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/cdsco-registration\/cdsco-import-license\/\"><span style=\"font-weight: 400;\">Indian CDSCO Import Registration<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/medical-device-registration-in-saudi-arabia\/\"><span style=\"font-weight: 400;\">SFDA<\/span><\/a><span style=\"font-weight: 400;\">, and <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/uk-ca-marking\/\"><span style=\"font-weight: 400;\">UKCA compliance<\/span><\/a><span style=\"font-weight: 400;\">. We also support the establishment of manufacturing facilities by offering services such as <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/manufacturing-facility\/\"><span style=\"font-weight: 400;\">facility layout design<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/clean-room-guidance\/\"><span style=\"font-weight: 400;\">cleanroom planning<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/validation-doc\/\"><span style=\"font-weight: 400;\">machine validation<\/span><\/a><span style=\"font-weight: 400;\">, and ensuring facility adherence to global regulatory standards ensuring quality through <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/iso-13485\/\"><span style=\"font-weight: 400;\">ISO 13485<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/fda-21-cfr-part820\/\"><span style=\"font-weight: 400;\">FDA QSR<\/span><\/a><span style=\"font-weight: 400;\"> and <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/mdsap\/\"><span style=\"font-weight: 400;\">MDSAP<\/span><\/a><span style=\"font-weight: 400;\"> compliance and all regulatory approvals.<\/span><\/p><p><span style=\"font-weight: 400;\">By choosing Operon Strategist, manufacturers gain a reliable partner dedicated to ensuring regulatory success and market readiness. Their proactive approach transforms challenges into opportunities, empowering businesses to thrive in the global medical device market. <\/span><\/p>\t\t\t\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>What is a Periodic Safety Update Report (PSUR) for Medical Devices? In the evolving regulatory landscape of medical devices, maintaining post-market vigilance is paramount. Among the essential elements of this framework is the Periodic Safety Update Report (PSUR), a critical requirement outlined under the European Union\u2019s Medical Device Regulation (MDR). This report ensures ongoing safety [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":8670,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-6898","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-manufacturing"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/6898","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/comments?post=6898"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/6898\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/media\/8670"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/media?parent=6898"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/categories?post=6898"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/tags?post=6898"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}