{"id":48,"date":"2022-11-01T12:50:39","date_gmt":"2022-11-01T12:50:39","guid":{"rendered":"https:\/\/operonstrategist.com\/costarica\/?page_id=48"},"modified":"2025-09-16T05:43:13","modified_gmt":"2025-09-16T05:43:13","slug":"us-fda-21-cfr-820-30-design-control-requirements","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/design-development-documentation\/us-fda-21-cfr-820-30-design-control-requirements\/","title":{"rendered":"US FDA 21 CFR 820.30 DESIGN CONTROL REQUIREMENTS"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"48\" class=\"elementor elementor-48\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5e725357 banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5e725357\" 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-2855af52\" data-id=\"2855af52\" 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-1c8d87cd banner-sec-heading elementor-widget elementor-widget-heading\" data-id=\"1c8d87cd\" 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\">US FDA 21 CFR 820.30 Design Control Requirements for Medical Devices 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-26be99d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"26be99d\" 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-079554d\" data-id=\"079554d\" 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-9ded6bc elementor-widget elementor-widget-text-editor\" data-id=\"9ded6bc\" 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 data-start=\"293\" data-end=\"781\">When it comes to US FDA 21 CFR 820.30 Design Control, many <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/manufacturing-facility\/\">medical device manufacturers<\/a> in Brazil face challenges in finding specialized consultants. This is because the regulation is part of the <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/fda-21-cfr-part-820-quality-system-regulation\/\">U.S. FDA\u2019s Quality System Regulation<\/a> (QSR), and much of the expertise is concentrated in the United States. However, international consulting firms like Operon Strategist provide expert support for Brazilian manufacturers aiming to export medical devices to the U.S. market. Our team helps companies in Brazil with implementing FDA-compliant design and development processes, aligning with QSR standards, and preparing the required technical documentation for<a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/fda-510-k\/\"> FDA 510(k)<\/a> or PMA submissions.<\/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-9692d26 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9692d26\" 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-a2dd958\" data-id=\"a2dd958\" 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-097b05c elementor-widget elementor-widget-heading\" data-id=\"097b05c\" 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 US FDA 21 CFR 820.30 Design Control Requirements<\/h2>\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-1256341 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1256341\" 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-c5cb86c\" data-id=\"c5cb86c\" 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-61ad5e9 elementor-widget elementor-widget-text-editor\" data-id=\"61ad5e9\" 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 data-start=\"1082\" data-end=\"1264\">US FDA 21 CFR 820.30 Design Control establishes essential processes to ensure medical devices are developed safely, effectively, and in compliance with regulatory requirements.<\/p><p data-start=\"1266\" data-end=\"1419\">For Brazilian manufacturers seeking entry into the U.S. market, it is mandatory to maintain documented design and development processes, including:<\/p><ul><li data-start=\"1422\" data-end=\"1457\">Design inputs and risk management<\/li><li data-start=\"1460\" data-end=\"1505\">Design outputs and technical specifications<\/li><li data-start=\"1508\" data-end=\"1541\">Design reviews and verification<\/li><li data-start=\"1544\" data-end=\"1576\">Design validation and transfer<\/li><li data-start=\"1579\" data-end=\"1604\">Managing design changes<\/li><li data-start=\"1607\" data-end=\"1652\">Maintaining a <a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/design-history-file-dhf-for-medical-devices\/\">Design History File<\/a> (DHF)<\/li><\/ul><p>\u00a0<\/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-2326827c elementor-widget-tablet__width-initial elementor-widget elementor-widget-image\" data-id=\"2326827c\" 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=\"1200\" height=\"628\" src=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/US-FDA-21-CFR-820.30-DESIGN-CONTROL-REQUIREMENTS.jpg\" class=\"attachment-full size-full wp-image-345\" alt=\"FDA 21 CFR Part 820\" srcset=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/US-FDA-21-CFR-820.30-DESIGN-CONTROL-REQUIREMENTS.jpg 1200w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/US-FDA-21-CFR-820.30-DESIGN-CONTROL-REQUIREMENTS-300x157.jpg 300w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/US-FDA-21-CFR-820.30-DESIGN-CONTROL-REQUIREMENTS-1024x536.jpg 1024w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/US-FDA-21-CFR-820.30-DESIGN-CONTROL-REQUIREMENTS-768x402.jpg 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<div class=\"elementor-column elementor-col-50 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class=\"elementor-section elementor-top-section elementor-element elementor-element-613d41ce elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"613d41ce\" 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-18357d36\" data-id=\"18357d36\" 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-46884f80 elementor-widget elementor-widget-heading\" data-id=\"46884f80\" 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\">Design Control 21 CFR 820.30 Process for Medical Devices :<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-361cf954 elementor-widget elementor-widget-text-editor\" data-id=\"361cf954\" 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 style=\"font-family: georgia, palatino; font-size: 12pt;\">Build up and maintain a plan that describes the design and development activities and allocates the individual obligations for each activity. Guarantee you review, update and approve the plan until the device design is completed, verified and validated.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7a3727d5 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7a3727d5\" 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-inner-column elementor-element elementor-element-3eabd04f\" data-id=\"3eabd04f\" 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-5b6a204 elementor-widget elementor-widget-image\" data-id=\"5b6a204\" 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=\"628\" src=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/DD-01-01.jpg\" class=\"attachment-full size-full wp-image-346\" alt=\"\" srcset=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/DD-01-01.jpg 1200w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/DD-01-01-300x157.jpg 300w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/DD-01-01-1024x536.jpg 1024w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/DD-01-01-768x402.jpg 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-inner-section elementor-element elementor-element-16514f6a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"16514f6a\" 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-33 elementor-inner-column elementor-element elementor-element-2783da39\" data-id=\"2783da39\" 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-751fc12 elementor-widget elementor-widget-heading\" data-id=\"751fc12\" 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\">Design Input :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-77b3ef9 elementor-widget elementor-widget-text-editor\" data-id=\"77b3ef9\" 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 style=\"font-family: georgia, palatino; font-size: 12pt;\">Utilize performance, safety, business economics, outputs of risk management and regulatory requirements as a basis to plan the device with the goal that its motivation and the proposed utilize are clear. The input may also come from surveying your customers( For example, clinicians, nurses, patients).<\/span><\/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-71d49c27 elementor-widget elementor-widget-heading\" data-id=\"71d49c27\" 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\">Design Output :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7dc1b964 elementor-widget elementor-widget-text-editor\" data-id=\"7dc1b964\" 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 style=\"font-family: georgia, palatino; font-size: 12pt;\">Design output methods or particulars need to stipulate or refer to the design input document developed by the team and need to identify the critical measures\/outputs for the best possible capacity of the device. These incorporate the tests and strategies that may have been produced, adjusted or used to show conformance with the characterized configuration inputs. Examples of design outputs may include:<\/span><\/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-65973bb3 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"65973bb3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check-circle\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">The device itself.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check-circle\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">The user manual.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check-circle\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Specifications A Risk Analysis Study results (For examples, validation and biocompatibility studies, storage).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check-circle\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Technical Files.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78e64889 elementor-widget elementor-widget-heading\" data-id=\"78e64889\" 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\">Design Review :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7955de56 elementor-widget elementor-widget-text-editor\" data-id=\"7955de56\" 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 style=\"font-family: georgia, palatino; font-size: 12pt;\">Confirm the design, or identify at an opportune time and right any insufficiencies distinguished at other plan and improvement phases. Two common types of review are hazard analysis, and failure mode and effect analysis.<\/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-33 elementor-inner-column elementor-element elementor-element-2fe09615\" data-id=\"2fe09615\" 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-683a5fe8 elementor-widget elementor-widget-image\" data-id=\"683a5fe8\" 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 loading=\"lazy\" decoding=\"async\" width=\"453\" height=\"1024\" src=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/US-FDA-21-CFR-820.30-Design-Control-Requirements-1.jpg\" class=\"attachment-full size-full wp-image-347\" alt=\"\" srcset=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/US-FDA-21-CFR-820.30-Design-Control-Requirements-1.jpg 453w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/US-FDA-21-CFR-820.30-Design-Control-Requirements-1-133x300.jpg 133w\" sizes=\"(max-width: 453px) 100vw, 453px\" \/>\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<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-649cca70\" data-id=\"649cca70\" 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-227674c1 elementor-widget elementor-widget-heading\" data-id=\"227674c1\" 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\">Design Verification :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6b2ef5ca elementor-widget elementor-widget-text-editor\" data-id=\"6b2ef5ca\" 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 style=\"font-family: georgia, palatino; font-size: 12pt;\">Confirm the device outline by means of examination and target prove, verify that the design outputs meet the plan inputs. Design verification activities must be arranged and routinely analyzed and the outcomes must be documented.<\/span><\/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-675ee1c3 elementor-widget elementor-widget-heading\" data-id=\"675ee1c3\" 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\">Design Validation :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5eb0971f elementor-widget elementor-widget-text-editor\" data-id=\"5eb0971f\" 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 style=\"font-family: georgia, palatino; font-size: 12pt;\">Approve the device design plan by means of examination and target prove, affirm that the last outline yield reliably meets the particular planned utilize. Design validation should follow successful design verification. Since outline check is directed while the plan work is being performed, design validation confirms that the medical device meets its intended use. Generally, this is set up through in vitro execution, practical testing, creature testing and additionally in vivo clinical assessments and trials.<\/span><\/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-2bd280d8 elementor-widget elementor-widget-heading\" data-id=\"2bd280d8\" 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\">Design Changes :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e457844 elementor-widget elementor-widget-text-editor\" data-id=\"3e457844\" 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 style=\"font-family: georgia, palatino; font-size: 12pt;\">Guarantee that all plan changes are distinguished, documented, approved, verified, reviewed and endorsed before usage.<\/span><\/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-716a97ed elementor-widget elementor-widget-heading\" data-id=\"716a97ed\" 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\">Design Transfer :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48cd5a55 elementor-widget elementor-widget-text-editor\" data-id=\"48cd5a55\" 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 style=\"font-family: georgia, palatino; font-size: 12pt;\">Ensure that the design of the medical device can be correctly translated into production specifications (that is, advancing successfully from product development to manufacturing).<\/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\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-3d9781b7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3d9781b7\" 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-469d70ab\" data-id=\"469d70ab\" data-element_type=\"column\" data-e-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<div class=\"elementor-element elementor-element-2b287467 elementor-widget elementor-widget-heading\" data-id=\"2b287467\" 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\">Ready to take your medical device to the U.S. market?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4723983d elementor-align-center elementor-widget elementor-widget-button\" data-id=\"4723983d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/operonstrategist.com\/en-br\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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-f877597 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f877597\" 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-eddb9d2\" data-id=\"eddb9d2\" 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-92f667e elementor-widget elementor-widget-heading\" data-id=\"92f667e\" 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\">Operon Strategist\u2019s Role in Supporting Brazilian Manufacturers<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9720039 elementor-widget elementor-widget-text-editor\" data-id=\"9720039\" 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 data-start=\"3277\" data-end=\"3409\">At Operon Strategist, we specialize in consulting for US FDA 21 CFR 820.30 Design Control in Brazil. Our services include:<\/p><ul><li data-start=\"3412\" data-end=\"3471\">Developing FDA-compliant<a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/design-development-documentation\/\"> design and development processes<\/a><\/li><li data-start=\"3474\" data-end=\"3532\">Bridging gaps between<a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/iso-13485-qms-medical-device\/\"> ISO 13485<\/a>:2016 and <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/fda-21-cfr-part-820-quality-system-regulation\/\">FDA QSR<\/a><\/li><li data-start=\"3535\" data-end=\"3595\">Preparing documentation for 510(k) and PMA submissions<\/li><li data-start=\"3598\" data-end=\"3662\">Training teams in verification, validation, and <a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/design-history-file-dhf-for-medical-devices\/\">DHF management<\/a><\/li><\/ul><p data-start=\"3664\" data-end=\"3784\">We help Brazilian manufacturers strengthen compliance, minimize risks, and achieve faster approval in the U.S. market.<\/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-fc54255 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fc54255\" 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-8b37d13\" data-id=\"8b37d13\" 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-43a34bd elementor-widget elementor-widget-heading\" data-id=\"43a34bd\" 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'S<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f47be20 elementor-widget elementor-widget-shortcode\" data-id=\"f47be20\" 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 US FDA 21 CFR 820.30 Design Control?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>It is a regulation under the FDA\u2019s Quality System Regulation (QSR) that defines design and development requirements for medical devices, ensuring safety and compliance.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-2\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">Is compliance with 21 CFR 820.30 mandatory for Brazilian manufacturers exporting to the U.S.?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Yes. Any manufacturer in Brazil that wants to sell medical devices in the U.S. must comply with FDA QSR, including design controls.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-3\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">How does design control impact FDA approval?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Strong design controls reduce risks of rejection, ensure safety, and create the documentation trail required for 510(k) or PMA approval.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-4\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">Do ISO 13485 design controls fulfill FDA 21 CFR 820.30 requirements?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>While ISO 13485 is closely aligned with FDA QSR, it is not identical. Operon Strategist helps Brazilian manufacturers comply with both standards.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-5\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">What is a Design History File (DHF), and why is it important?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>A DHF is a collection of documents that prove a device was designed according to FDA requirements. It is essential during inspections and submissions.<\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2f0fb60f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2f0fb60f\" 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-1a4eb544\" data-id=\"1a4eb544\" 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-3cdcb072 elementor-widget elementor-widget-heading\" data-id=\"3cdcb072\" 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<h4 class=\"elementor-heading-title elementor-size-default\">Operon Strategist Provides  FDA 510k Consultancy Services in Worldwide<\/h4>\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-inner-section elementor-element elementor-element-cbda44d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"cbda44d\" 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-25 elementor-inner-column elementor-element elementor-element-95017f6\" data-id=\"95017f6\" 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-a3218ff elementor-widget elementor-widget-text-editor\" data-id=\"a3218ff\" 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><a href=\"https:\/\/operonstrategist.com\/en-sa\/services\/turnkey-project\/\"><strong>Saudi Arabia<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/turnkey-project-consultants\/\"><strong>Egypt<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-ir\/services\/turnkey-project-consultants\/\"><strong>Iran<\/strong><\/a><\/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-25 elementor-inner-column elementor-element elementor-element-22c19fe3\" data-id=\"22c19fe3\" 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-8c79a62 elementor-widget elementor-widget-text-editor\" data-id=\"8c79a62\" 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><a href=\"https:\/\/operonstrategist.com\/en-gb\/services\/turnkey-project-consultants\/\"><strong>The UK<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-de\/services\/turnkey-project-consultants\/\"><strong>Germany\u00a0<\/strong><\/a><\/p><p><strong><a href=\"https:\/\/operonstrategist.com\/en-cr\/services\/turnkey-project-consultants\/\">Costa Rica<\/a><\/strong><\/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-25 elementor-inner-column elementor-element elementor-element-66b72dd9\" data-id=\"66b72dd9\" 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-483b84f5 elementor-widget elementor-widget-text-editor\" data-id=\"483b84f5\" 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><a href=\"https:\/\/operonstrategist.com\/en-nl\/services\/turnkey-project-consultants\/\"><strong>Netherlands<\/strong><\/a><\/p><p><strong><a href=\"https:\/\/operonstrategist.com\/en-om\/services\/turnkey-project-consultants\/\">Oman<\/a><\/strong><\/p><p><strong><a href=\"https:\/\/us.operonstrategist.com\/services\/turnkey-project-consultants-in-usa\/\">US<\/a><\/strong><\/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-25 elementor-inner-column elementor-element elementor-element-bfe45a9\" data-id=\"bfe45a9\" 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-353bbb73 elementor-widget elementor-widget-text-editor\" data-id=\"353bbb73\" 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><a href=\"https:\/\/operonstrategist.com\/en-za\/services\/turnkey-project-consultants\/\"><strong>South Africa<\/strong><\/a><\/p><p><strong><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/\">India<\/a><\/strong><\/p><p><strong><a href=\"https:\/\/operonstrategist.com\/en-dz\/services\/turnkey-project-consultants\/\">Algeria<\/a><\/strong><\/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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>US FDA 21 CFR 820.30 Design Control Requirements for Medical Devices in Brazil When it comes to US FDA 21 CFR 820.30 Design Control, many medical device manufacturers in Brazil face challenges in finding specialized consultants. This is because the regulation is part of the U.S. FDA\u2019s Quality System Regulation (QSR), and much of the [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":345,"parent":22,"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-48","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/48","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=48"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/48\/revisions"}],"predecessor-version":[{"id":3842,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/48\/revisions\/3842"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/22"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media\/345"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media?parent=48"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}