{"id":34,"date":"2022-11-01T12:43:39","date_gmt":"2022-11-01T12:43:39","guid":{"rendered":"https:\/\/operonstrategist.com\/costarica\/?page_id=34"},"modified":"2025-09-17T08:25:48","modified_gmt":"2025-09-17T08:25:48","slug":"fda-21-cfr-part-820-quality-system-regulation","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/fda-21-cfr-part-820-quality-system-regulation\/","title":{"rendered":"FDA 21 CFR PART 820 QUALITY SYSTEM REGULATION"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"34\" class=\"elementor elementor-34\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3ba68bd2 banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3ba68bd2\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-724f2db6\" data-id=\"724f2db6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4f508496 banner-sec-heading elementor-widget elementor-widget-heading\" data-id=\"4f508496\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">FDA 21 CFR Part 820 Quality System Regulation Consultant in Brazil <\/h1>\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-99308c0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"99308c0\" data-element_type=\"section\" data-e-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-3625606e\" data-id=\"3625606e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b2cd420 elementor-widget elementor-widget-heading\" data-id=\"b2cd420\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Overview of FDA 21 CFR Part 820 Quality System Regulation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-306294a elementor-widget elementor-widget-text-editor\" data-id=\"306294a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span class=\"TextRun SCXW266169870 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266169870 BCX8\">The <\/span><\/span><span class=\"TextRun SCXW266169870 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266169870 BCX8\">FDA 21 CFR Part 820 Quality System Regulation (QSR)<\/span><\/span><span class=\"TextRun SCXW266169870 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266169870 BCX8\"> outlines the requirements for medical device manufacturers to <\/span><span class=\"NormalTextRun SCXW266169870 BCX8\">establish<\/span><span class=\"NormalTextRun SCXW266169870 BCX8\"> and maintain a <\/span><\/span><span class=\"TextRun SCXW266169870 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266169870 BCX8\"><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/quality-management-system\/\">Quality Management System<\/a> (QMS)<\/span><\/span><span class=\"TextRun SCXW266169870 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266169870 BCX8\"> in compliance with U.S. FDA standards. These regulations ensure that medical devices are designed, manufactured, packaged, stored, and serviced with the highest quality and safety standards.<\/span><\/span><span class=\"EOP SCXW266169870 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW249660131 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW249660131 BCX8\">At <\/span><\/span><span class=\"TextRun SCXW249660131 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW249660131 BCX8\">Operon Strategist<\/span><\/span><span class=\"TextRun SCXW249660131 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW249660131 BCX8\">, we help Brazilian medical device manufacturers align with <\/span><\/span><span class=\"TextRun SCXW249660131 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW249660131 BCX8\">FDA QSR 21 CFR Part 820<\/span><\/span><span class=\"TextRun SCXW249660131 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW249660131 BCX8\"> requirements, enabling successful market entry into the United States.<\/span><\/span><span class=\"EOP SCXW249660131 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-29f7eee9 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"29f7eee9\" data-element_type=\"section\" data-e-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-50 elementor-top-column elementor-element elementor-element-37b58591\" data-id=\"37b58591\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-561e0f70 elementor-widget elementor-widget-heading\" data-id=\"561e0f70\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is FDA 21 CFR Part 820 Quality System Regulation? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6562ab37 elementor-widget elementor-widget-text-editor\" data-id=\"6562ab37\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span data-contrast=\"auto\">FDA 21 CFR Part 820 is a section of the U.S. <\/span><b><span data-contrast=\"auto\">Code of Federal Regulations<\/span><\/b><span data-contrast=\"auto\"> specifically focused on <\/span><b><span data-contrast=\"auto\">quality system requirements for medical devices<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><span data-contrast=\"auto\">It governs:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><ul><li><span data-contrast=\"auto\">Design and development<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><span data-contrast=\"auto\">Manufacturing and process controls<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><span data-contrast=\"auto\">Packaging and labeling<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><span data-contrast=\"auto\">Storage and distribution<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><span data-contrast=\"auto\">Installation and servicing of medical devices<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><p><span data-contrast=\"auto\">Unlike ISO 13485 certification, <\/span><b><span data-contrast=\"auto\">FDA 21 CFR Part 820 does not have a certification process<\/span><\/b><span data-contrast=\"auto\">. Instead, manufacturers must demonstrate compliance through <\/span><b><span data-contrast=\"auto\">FDA inspections<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\t\t\t\t\t\t\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-32000545\" data-id=\"32000545\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-571f4d99 elementor-widget elementor-widget-image\" data-id=\"571f4d99\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"2500\" height=\"1246\" src=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/FDA-21-CFR-Part-820-Quality-System-Regulation-01.jpg\" class=\"attachment-full size-full wp-image-3686\" alt=\"FDA 21 CFR Part 820 Quality System Regulation\" srcset=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/FDA-21-CFR-Part-820-Quality-System-Regulation-01.jpg 2500w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/FDA-21-CFR-Part-820-Quality-System-Regulation-01-300x150.jpg 300w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/FDA-21-CFR-Part-820-Quality-System-Regulation-01-1024x510.jpg 1024w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/FDA-21-CFR-Part-820-Quality-System-Regulation-01-768x383.jpg 768w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/FDA-21-CFR-Part-820-Quality-System-Regulation-01-1536x766.jpg 1536w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/08\/FDA-21-CFR-Part-820-Quality-System-Regulation-01-2048x1021.jpg 2048w\" sizes=\"(max-width: 2500px) 100vw, 2500px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-131070b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"131070b\" data-element_type=\"section\" data-e-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-50 elementor-top-column elementor-element elementor-element-ec2c82f\" data-id=\"ec2c82f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eb3d0bd elementor-widget elementor-widget-heading\" data-id=\"eb3d0bd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why is FDA 21 CFR Part 820 Compliance Important? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6eeedfc elementor-widget elementor-widget-text-editor\" data-id=\"6eeedfc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span data-contrast=\"auto\">For Brazilian medical device manufacturers targeting the U.S. market, compliance with <\/span><b><span data-contrast=\"auto\">21 CFR Part 820<\/span><\/b><span data-contrast=\"auto\"> is mandatory. Non-compliance can lead to:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"43\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">FDA warning letters<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"43\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Import refusals<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"43\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Product recalls<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"43\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Severe damage to brand reputation<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><p><span data-contrast=\"auto\">Adhering to FDA QSR ensures that your devices are safe, effective, and meet global regulatory expectations.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\t\t\t\t\t\t\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-eecd441 animated-slow\" data-id=\"eecd441\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ff406d1 elementor-widget elementor-widget-heading\" data-id=\"ff406d1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Let's Grow Your Business Together<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c528f7a elementor-widget elementor-widget-text-editor\" data-id=\"c528f7a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Fill the Form or Mail Us to:\u00a0<a href=\"mailto:enquiry@operonstrategist.com\">enquiry@operonstrategist.com<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5d1111 elementor-widget elementor-widget-wpforms\" data-id=\"b5d1111\" 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-2624\"><form id=\"wpforms-form-2624\" class=\"wpforms-validate 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value=\"2624\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/34\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-2624\" 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\/en-br\/wp-content\/plugins\/wpforms-lite\/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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-63054b0f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"63054b0f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&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-100 elementor-top-column elementor-element elementor-element-4bccd8dd\" data-id=\"4bccd8dd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-42da8875 elementor-widget elementor-widget-heading\" data-id=\"42da8875\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why Should you Care About 21 CFR Part 820? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5097a846 elementor-widget elementor-widget-text-editor\" data-id=\"5097a846\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Medical device manufacturers must adhere to 21 CFR Part 820 regulations to avoid potential issues during inspections. Failing to meet these standards can result in an FDA warning letter, which can severely damage your reputation and adversely affect market performance. When importing devices from the U.S. to the U.S. market, it&#8217;s essential to ensure they comply with Quality System Regulation (QSR) requirements to avoid these risks.<\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5393ef30 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5393ef30\" data-element_type=\"section\" data-e-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-119665e\" data-id=\"119665e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5d02d293 elementor-widget elementor-widget-image\" data-id=\"5d02d293\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1200\" height=\"499\" src=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/21-cfr-part-820.png\" class=\"attachment-full size-full wp-image-316\" alt=\"\" srcset=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/21-cfr-part-820.png 1200w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/21-cfr-part-820-300x125.png 300w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/21-cfr-part-820-1024x426.png 1024w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/21-cfr-part-820-768x319.png 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-be6869f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"be6869f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&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-100 elementor-top-column elementor-element elementor-element-5bc7d720\" data-id=\"5bc7d720\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-27d4c495 elementor-widget elementor-widget-heading\" data-id=\"27d4c495\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How Operon Strategist Supports FDA 21 CFR Part 820 Compliance <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b1ba5f4 elementor-widget elementor-widget-text-editor\" data-id=\"4b1ba5f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span data-contrast=\"auto\">We provide <\/span><b><span data-contrast=\"auto\">end-to-end consulting services<\/span><\/b><span data-contrast=\"auto\"> to help manufacturers in Brazil achieve compliance:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">\u2705 <\/span><b><span data-contrast=\"auto\">Gap Analysis<\/span><\/b><span data-contrast=\"auto\"> \u2013 Assess your existing QMS against FDA 21 CFR Part 820 requirements<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">\u2705 <\/span><b><span data-contrast=\"auto\">QMS Implementation<\/span><\/b><span data-contrast=\"auto\"> \u2013 Align processes with FDA standards<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">\u2705 <\/span><b><span data-contrast=\"auto\">Training Programs<\/span><\/b><span data-contrast=\"auto\"> \u2013 Comprehensive training for your quality and regulatory teams<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">\u2705 <\/span><b><span data-contrast=\"auto\">Documentation Support<\/span><\/b><span data-contrast=\"auto\"> \u2013 Guidance on preparing and maintaining FDA-compliant records<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">\u2705 <\/span><b><span data-contrast=\"auto\">Mock Audits<\/span><\/b><span data-contrast=\"auto\"> \u2013 Simulated FDA inspections to identify and correct gaps<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">\u2705 <\/span><b><span data-contrast=\"auto\">Post-Inspection Support<\/span><\/b><span data-contrast=\"auto\"> \u2013 Assistance in addressing FDA findings and ensuring continuous compliance<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">By working with us, manufacturers can establish robust quality systems and ensure smooth market entry into the United States.<\/span><\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-51ce9ad5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"51ce9ad5\" data-element_type=\"section\" data-e-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-11fd8f79\" data-id=\"11fd8f79\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-67408dd elementor-widget elementor-widget-heading\" data-id=\"67408dd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why Choose Operon Strategist? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-24a486d3 elementor-widget elementor-widget-text-editor\" data-id=\"24a486d3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li><span data-contrast=\"auto\">Expertise in <\/span><b><span data-contrast=\"auto\">FDA 21 CFR Part 820, <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/fda-510-k\/\">FDA 510(k)<\/a>, and combination product regulations<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><span data-contrast=\"auto\">Experience across <\/span><b><span data-contrast=\"auto\">global regulatory authorities<\/span><\/b><span data-contrast=\"auto\"> including <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/anvisa-medical-device-registration-in-brazil\/\">ANVISA<\/a>, <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/fda-510-k\/\">US FDA<\/a>, <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/sfda-approval\/\">SFDA<\/a>, EDA, and MHRA<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><span data-contrast=\"auto\">Tailored solutions for startups, SMEs, and large-scale manufacturers<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><li><span data-contrast=\"auto\">Proven success in helping medical device companies achieve U.S. market approvals<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li><\/ul><p><span data-contrast=\"auto\">We are not just consultants\u2014we are <\/span><b><span data-contrast=\"auto\">your regulatory partners<\/span><\/b><span data-contrast=\"auto\"> in ensuring compliance, quality, and successful commercialization of medical devices.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p><p><span style=\"font-family: georgia, palatino; font-size: 12pt;\">We also provide medical device consultation for\u00a0<a href=\"https:\/\/operonstrategist.com\/\">India,<\/a>\u00a0<a href=\"https:\/\/operonstrategist.com\/en-sa\/\" target=\"_blank\" rel=\"noopener\">Saudi Arabia<\/a>,<a href=\"https:\/\/us.operonstrategist.com\/\" rel=\"nofollow noopener\">\u00a0the USA<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-gb\/\">the UK<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-za\/\">South Africa<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-om\/\">Oman<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-ir\/\">Iran<\/a>\u00a0&amp;\u00a0<a href=\"https:\/\/operonstrategist.com\/en-gb\/\">Egypt<\/a>. Feel free to <a href=\"https:\/\/operonstrategist.com\/en-cr\/contact-us\/\">contact us.<\/a><\/span><\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c9333da elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c9333da\" data-element_type=\"section\" data-e-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-16dc90a\" data-id=\"16dc90a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-297e93d elementor-widget elementor-widget-heading\" data-id=\"297e93d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQ <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-efabe14 elementor-widget elementor-widget-shortcode\" data-id=\"efabe14\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\"><div id=\"rank-math-rich-snippet-wrapper\"><div id=\"rank-math-faq\" class=\"rank-math-block\">\n<div class=\"rank-math-list \">\n<div id=\"faq-1\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">What is FDA 21 CFR Part 820?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), establishes the requirements for medical device manufacturers to ensure their products meet safety and efficacy standards before entering the U.S. market.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-2\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">Who needs to comply with FDA 21 CFR Part 820?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>All medical device manufacturers, including those in Brazil exporting to the U.S., must comply with FDA 21 CFR Part 820 to meet regulatory requirements and avoid enforcement actions such as warning letters or recalls.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-3\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">How does Operon Strategist help with FDA 21 CFR Part 820 compliance?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Operon Strategist assists medical device manufacturers with gap analysis, QMS documentation, internal audits, risk management, and preparation for FDA inspections to ensure full compliance with 21 CFR Part 820.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-4\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">What are the key elements of FDA 21 CFR Part 820?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Key elements of FDA 21 CFR Part 820 include design controls, production and process controls, CAPA (Corrective and Preventive Actions), supplier management, complaint handling, and internal audits.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-5\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">What is the difference between ISO 13485 and FDA 21 CFR Part 820?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>ISO 13485 is an international QMS standard for medical devices, while FDA 21 CFR Part 820 is a U.S. regulatory requirement. Compliance with ISO 13485 helps with FDA QSR compliance, but additional steps may be needed to meet FDA expectations.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div>\n\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>FDA 21 CFR Part 820 Quality System Regulation Consultant in Brazil Overview of FDA 21 CFR Part 820 Quality System Regulation The FDA 21 CFR Part 820 Quality System Regulation (QSR) outlines the requirements for medical device manufacturers to establish and maintain a Quality Management System (QMS) in compliance with U.S. FDA standards. These regulations [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":3686,"parent":18,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-34","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/34","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/comments?post=34"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/34\/revisions"}],"predecessor-version":[{"id":3871,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/34\/revisions\/3871"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/18"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media\/3686"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media?parent=34"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}