{"id":455,"date":"2022-11-15T11:11:59","date_gmt":"2022-11-15T11:11:59","guid":{"rendered":"https:\/\/operonstrategist.com\/egypt\/?page_id=455"},"modified":"2026-02-09T10:32:02","modified_gmt":"2026-02-09T10:32:02","slug":"drug-device-combination-product","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-eg\/services\/regulatory-approvals\/design-and-development-documentation\/drug-device-combination-product\/","title":{"rendered":"DRUG DEVICE COMBINATION PRODUCT"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"455\" class=\"elementor elementor-455\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-65708d4d banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"65708d4d\" 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-1e9d490a exad-glass-effect-no exad-sticky-section-no\" data-id=\"1e9d490a\" 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-46135074 banner-sec-heading exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"46135074\" 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\">\nDrug Device Combination Products<\/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-6264afb elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"6264afb\" 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-a447493 exad-glass-effect-no exad-sticky-section-no\" data-id=\"a447493\" 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-c269e69 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"c269e69\" 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 Drug Device Combination Products?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7425a52 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"7425a52\" 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=\"none\">A combination product as indicated by the Code of Federal Regulation, CFR is expressed as a product that includes a medical device \/or a medication\/or a biologic consolidating any two of these classifications and at some point, even every one of the three. The well-known term of combination product is the drug eluting stent (DES) which is a scaffold covered with a drug to prevent scar tissue from developing in the supply artery. Most of the individuals have a constrained perspective on combination products. Today combination product is under development which includes a lot a larger number of things than just drugs, device or biological product, medical device. They include foods, they include nutraceuticals, and cosmetics agents or supposed as cosmeceuticals. Products that combine drug with device are named as Drug device combination.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><p><strong>As per the FDA combination product, types of combination product can be,\u00a0<\/strong><\/p><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><p><span data-contrast=\"none\">single entity,<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><p><span data-contrast=\"none\">cross labelled, <\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><p><span data-contrast=\"none\">co-packaged.<\/span><\/p><\/li><\/ul>\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-720b1ad exad-glass-effect-no exad-sticky-section-no\" data-id=\"720b1ad\" 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-fad93bd exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"fad93bd\" 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<div class=\"elementor-element elementor-element-279d184 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" style=\"flex-basis: var(--flex-basis); flex-grow: var(--flex-grow); flex-shrink: var(--flex-shrink); order: var(--order); align-self: var(--align-self); flex-direction: var(--flex-direction); flex-wrap: var(--flex-wrap); justify-content: var(--justify-content); align-items: var(--align-items); align-content: var(--align-content); gap: var(--gap); --swiper-theme-color: #000; --swiper-navigation-size: 44px; --swiper-pagination-bullet-size: 6px; --swiper-pagination-bullet-horizontal-gap: 6px; --widgets-spacing: 20px 20px; width: 485.375px; text-align: center; color: #000000; font-family: Poppins, sans-serif;\" data-id=\"279d184\" data-element_type=\"widget\" data-widget_type=\"heading.default\"><div class=\"elementor-widget-container\" style=\"transition: background .3s,border .3s,border-radius .3s,box-shadow .3s,transform var(--e-transform-transition-duration,.4s); margin: 0px; padding: 0px;\"><h1 class=\"elementor-heading-title elementor-size-default\" style=\"font-weight: var( --e-global-typography-primary-font-weight ); color: #212121; font-family: var( --e-global-typography-primary-font-family ), Sans-serif; -webkit-text-stroke-color: #000000; stroke: #000000;\">Looking for Consultant?<\/h1><\/div><\/div><div class=\"elementor-element elementor-element-910e680 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" style=\"flex-basis: var(--flex-basis); flex-grow: var(--flex-grow); flex-shrink: var(--flex-shrink); order: var(--order); align-self: var(--align-self); flex-direction: var(--flex-direction); flex-wrap: var(--flex-wrap); justify-content: var(--justify-content); align-items: var(--align-items); align-content: var(--align-content); column-gap: 0px; --swiper-theme-color: #000; --swiper-navigation-size: 44px; --swiper-pagination-bullet-size: 6px; --swiper-pagination-bullet-horizontal-gap: 6px; --widgets-spacing: 20px 20px; color: #bdbdbd; font-family: var( --e-global-typography-secondary-font-family ), Sans-serif; font-weight: 400; width: 485.375px; text-align: center;\" data-id=\"910e680\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\" style=\"transition: background .3s,border .3s,border-radius .3s,box-shadow .3s,transform var(--e-transform-transition-duration,.4s);\"><p style=\"font-size: 15px;\">Let\u2019s have word about your next project<\/p><\/div><\/div>\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-1eeb404 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-wpforms\" data-id=\"1eeb404\" 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\" id=\"wpforms-18\"><form id=\"wpforms-form-18\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"18\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/en-eg\/wp-json\/wp\/v2\/pages\/455\" data-token=\"cbdb6ae1169698a5cc13aa45eecea193\" data-token-time=\"1775825493\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div class=\"wpforms-field-container\"><div id=\"wpforms-18-field_0-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"0\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-18-field_0\">Name <span class=\"wpforms-required-label\">*<\/span><\/label><input type=\"text\" id=\"wpforms-18-field_0\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][0]\" placeholder=\"Name\" required><\/div><div id=\"wpforms-18-field_1-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-18-field_1\">Email <span class=\"wpforms-required-label\">*<\/span><\/label><input type=\"email\" id=\"wpforms-18-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Email\" spellcheck=\"false\" required><\/div><div id=\"wpforms-18-field_3-container\" class=\"wpforms-field wpforms-field-number\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-18-field_3\">Phone <span class=\"wpforms-required-label\">*<\/span><\/label><input type=\"number\" id=\"wpforms-18-field_3\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][3]\" placeholder=\"Phone\" step=\"any\" required><\/div><div id=\"wpforms-18-field_2-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-18-field_2\">Message<\/label><textarea id=\"wpforms-18-field_2\" class=\"wpforms-field-small\" name=\"wpforms[fields][2]\" placeholder=\"Message\" ><\/textarea><\/div><div id=\"wpforms-18-field_4-container\" class=\"wpforms-field wpforms-field-select wpforms-field-select-style-classic\" data-field-id=\"4\"><label class=\"wpforms-field-label\" for=\"wpforms-18-field_4\">From Where Did You Here About Us? <span class=\"wpforms-required-label\">*<\/span><\/label><select id=\"wpforms-18-field_4\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][4]\" required=\"required\"><option value=\"Google\/Web Search\"  class=\"choice-1 depth-1\"  >Google\/Web Search<\/option><option value=\"Social Media\"  class=\"choice-2 depth-1\"  >Social Media<\/option><option value=\"Email Marketing\"  class=\"choice-3 depth-1\"  >Email Marketing<\/option><option value=\"Referred By Colleague\"  class=\"choice-7 depth-1\"  >Referred By Colleague<\/option><option value=\"Shows\/Exhibitions\"  class=\"choice-6 depth-1\"  >Shows\/Exhibitions<\/option><option value=\"Print Advertisement\"  class=\"choice-5 depth-1\"  >Print Advertisement<\/option><option value=\"Other\"  class=\"choice-4 depth-1\"  >Other<\/option><\/select><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"18\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/455\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-18\" 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-eg\/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-8500864 elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"8500864\" 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-ba60dd9 exad-glass-effect-no exad-sticky-section-no\" data-id=\"ba60dd9\" 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-e5473a5 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"e5473a5\" 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-size: 16px;\">Combination Products\u202fexample like prefilled syringes, applicators of the tropical products. Manufactures should have adequate\u202fdesign and development activity done so as to prove the adequacy of the safety and efficacy of the product. The medical device design and development activity is the systematic methodology, which establishes the proper design and development of the products. Many of the customer complaints and 483\u2019s in case of the medical devices or combination devices are contributed to the improper of the design and development control activity. The design and development requirements of the product are described in\u202f<\/span><a style=\"font-size: 16px; background-color: #ffffff;\" href=\"https:\/\/operonstrategist.com\/en-eg\/services\/turnkey-project-consultants\/quality-management-system\/iso-13485-certification\/\"><span data-contrast=\"none\">ISO 13485 <\/span><\/a><span style=\"font-size: 16px;\" data-contrast=\"none\">\u202fand <a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/turnkey-project-consultants\/quality-management-system\/fda-21-cfr-part-820-quality-system-regulations\/\">21 CFR Part 820<\/a> also.\u00a0<\/span><span style=\"font-size: 16px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\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-2b0ebaa exad-glass-effect-no exad-sticky-section-no\" data-id=\"2b0ebaa\" 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-d5d8ef2 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-image\" data-id=\"d5d8ef2\" 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=\"1024\" height=\"510\" src=\"https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2025\/12\/Drug-Device-Combination-Products-01-1024x510.jpg\" class=\"attachment-large size-large wp-image-2919\" alt=\"drug-device-combination-product\" srcset=\"https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2025\/12\/Drug-Device-Combination-Products-01-1024x510.jpg 1024w, https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2025\/12\/Drug-Device-Combination-Products-01-300x150.jpg 300w, https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2025\/12\/Drug-Device-Combination-Products-01-768x383.jpg 768w, https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2025\/12\/Drug-Device-Combination-Products-01-1536x766.jpg 1536w, https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2025\/12\/Drug-Device-Combination-Products-01-2048x1021.jpg 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-5576eb4 elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"5576eb4\" 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-ee36e48 exad-glass-effect-no exad-sticky-section-no\" data-id=\"ee36e48\" 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-61d682c exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"61d682c\" 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 Combination Products Project Development Process &amp; Design Control?\u00a0<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-40c1915 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"40c1915\" 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=\"none\">The Pharmaceutical organization which manufactures the combination products are expected to implement the 21 CFR Part 210 and 211 and <\/span><a href=\"https:\/\/operonstrategist.com\/egypt\/services\/turnkey-project\/quality-management-system\/fda-21-cfr-part820\/\"><span data-contrast=\"none\">21 CFR Part 820<\/span><\/a><span data-contrast=\"none\"> for their manufacturing sites. At the end of the design Phases, the DHF is compiled and shall be presented during the audits.\u00a0 As The DMR shall be extracted from the DHF for routine use and tech transfer. The requirements mentioned in the DMR shall be used to create the DHR to demonstrate the routine production and compliances. As per the requirements of the ISO 13485:2016, the medical device file shall be established. The complexity of the design procedure is dependent on the Product complexity and intended use. Design control is a vital part as far as the Quality Management System goes. Our team takes hard efforts to implement proper QMS system for the USA <a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/turnkey-project-consultants\/manufacturing-facility\/\">medical device manufacturers.<\/a><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><p aria-level=\"2\"><span data-contrast=\"none\">Drug-Device Combination (DDC) as per MDR for <a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/regulatory-approvals\/ce-mark\/\">CE Marking<\/a><\/span><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:40,&quot;335559739&quot;:0,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><p><span data-contrast=\"none\">Integral DDCs are products falling under the second sub-paragraphs of both Article 1(8) and Article 1(9) 62 of the Regulation (EU) 2017\/745 on medical devices (the MDR).<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><p aria-level=\"2\"><span data-contrast=\"none\">Generally, These Devices Have Measuring, Metering or Delivery Functions.<\/span><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:40,&quot;335559739&quot;:0,&quot;335559740&quot;:259}\">\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-218f289 elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"218f289\" 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-9fd4d0b exad-glass-effect-no exad-sticky-section-no\" data-id=\"9fd4d0b\" 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-2bb2651 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"2bb2651\" 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<h3><span data-contrast=\"none\">Examples of medical devices in integral DDCs are:<\/span><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:40,&quot;335559739&quot;:0,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Devices for delivery to the site of action e.g., the dropper on the top of the container with eye drops the mouthpiece on the top of spray cans for throat sprays.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Single-dose pre-filled syringes, pens and injectors.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Multi-dose pens and injectors containing a pre-filled cartridge where the cartridge cannot be replaced, and the pen is not designed for subsequent use with a new cartridge.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Drug-releasing intra-uterine devices; pre-assembled, non-reusable applicators for vaginal tablets.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Dry powder inhalers that are assembled with the medicinal component and ready for use with single or multiple doses but cannot be refilled when all doses are taken.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Implants containing medicinal products whose primary purpose is to release the medicinal product.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><\/ul><h3><span data-contrast=\"none\">Examples of medical devices in integral DDCs are:<\/span><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:40,&quot;335559739&quot;:0,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Oral administration devices (e.g. cups, spoons, syringes)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">Injection needles and filter needles<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">Refillable pens and injectors (e.g. using cartridges).<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"none\">Reusable dry powder inhalers; spacers for inhalation sprays<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Pumps for medicinal product delivery<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">Electronic tablet dispensers<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><\/ul><h3><span data-contrast=\"none\">Each Manufacturer of a Medical Device in USA or all over the globe Shall Establish and Maintain the Following Procedures<\/span><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:40,&quot;335559739&quot;:0,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">Control the design of the device<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"none\">Ensure that specified design requirements are met<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><\/ul>\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-16c1fc66 elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"16c1fc66\" 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-55160b59 exad-glass-effect-no exad-sticky-section-no\" data-id=\"55160b59\" 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-18c04cc4 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"18c04cc4\" 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\">Need Expert Support to Accelerate Your Drug-Device Combination Product Approval?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4417d914 elementor-align-center exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-button\" data-id=\"4417d914\" 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-eg\/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 Now<\/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-29c635b elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"29c635b\" 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-b5f4983 exad-glass-effect-no exad-sticky-section-no\" data-id=\"b5f4983\" 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-6c1686c exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"6c1686c\" 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 CAPA Management for Combination Products?\u00a0<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5725c43 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"5725c43\" 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=\"none\">CAPA management<\/span><span data-contrast=\"none\"> of drugs and device combination products are as follow:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><p><span data-contrast=\"none\">To ensure that devices meet the requirement of Combination Products<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Users\u2019 needs and intended uses<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Requirements and Specifications<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">The regulatory pathway for combination products<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">Can be reproducibly and reliably manufactured, serviced and\/or installed.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><\/ul><p aria-level=\"2\"><span data-contrast=\"none\">Tools for Archiving Purpose of Combination Products<\/span><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:40,&quot;335559739&quot;:0,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"none\">Establish design control procedures.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Develop plans for Design Projects (Include interfaces between R&amp;D and other units)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">Identify design inputs requirements and high-level specifications for the device<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">Develop design outputs (to final specifications)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"none\">Design Verification through measurement, analysis, test or inspection that all design outputs fulfil input requirements.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"none\">Transfer outputs to production<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Design Validation that the device performs and functions as intended and as users need an expert.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">Control changes during design and development and to existing devices Document design activities in the design history file.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><\/ul><p><span data-contrast=\"none\">Operon Strategist as a reliable <\/span><span data-contrast=\"none\">medical device consultant<\/span><span data-contrast=\"none\"> assists companies and medical device manufacturers in USA, providing consulting services that support the registration of drug-device Combination Products. We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210\/211), Device (21 CFR 820) and 21 CFR Combination Products (21 CFR Part 4).\u00a0<\/span><\/p><div class=\"elementor-element elementor-element-6265c20f exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"6265c20f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p>We also provide medical device consultation for\u00a0<a href=\"https:\/\/operonstrategist.com\/\">India<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-za\/\">South Africa<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-eg\/\">Egypt,<\/a>\u00a0the\u00a0<a href=\"https:\/\/us.operonstrategist.com\/\">USA<\/a>, the\u00a0<a href=\"https:\/\/operonstrategist.com\/en-gb\/\">UK<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-cr\/\">Costa Rica<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-om\/\">Oman<\/a>, and\u00a0<a href=\"https:\/\/operonstrategist.com\/en-ir\/\">Iran.<\/a>\u00a0For free consultation\u00a0<a href=\"https:\/\/operonstrategist.com\/en-eg\/contact-us\/\">Contact us<\/a> now.\u00a0<\/p><\/div><\/div>\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-76670fb elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"76670fb\" 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-781a39c exad-glass-effect-no exad-sticky-section-no\" data-id=\"781a39c\" 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-eff1308 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"eff1308\" 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\">Role of Operon Strategist in Drug-Device Combination Products<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20a3207 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"20a3207\" 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=\"279\" data-end=\"577\">Operon Strategist is a specialized medical device regulatory consulting company supporting drug\u2013device combination product compliance and registration for global manufacturers. We provide hands-on regulatory and quality system consulting aligned with <a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/regulatory-approvals\/fda-510k\/\">US FDA<\/a> and EU MDR requirements.<\/p><h3 data-start=\"579\" data-end=\"635\">Our Combination Product Consulting Services Include:<\/h3><ul data-start=\"636\" data-end=\"1111\"><li data-start=\"636\" data-end=\"720\"><p data-start=\"638\" data-end=\"720\">Regulatory pathway assessment for drug-led and device-led combination products<\/p><\/li><li data-start=\"721\" data-end=\"797\"><p data-start=\"723\" data-end=\"797\">Design control implementation as per 21 CFR Part 820 and<a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/turnkey-project-consultants\/quality-management-system\/iso-13485-certification\/\"> ISO 13485<\/a><\/p><\/li><li data-start=\"798\" data-end=\"844\"><p data-start=\"800\" data-end=\"844\"><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/design-history-file-dhf-for-medical-devices\/\">DHF, <\/a>preparation and review<\/p><\/li><li data-start=\"845\" data-end=\"903\"><p data-start=\"847\" data-end=\"903\"><a href=\"https:\/\/operonstrategist.com\/correction-vs-corrective-action-vs-preventive-action-capa-differences-and-best-practices\/\">CAPA management<\/a> for drug-device combination products<\/p><\/li><li data-start=\"904\" data-end=\"971\"><p data-start=\"906\" data-end=\"971\">Integration of 21 CFR Parts 210, 211, and Part 4 requirements<\/p><\/li><li data-start=\"972\" data-end=\"1038\"><p data-start=\"974\" data-end=\"1038\">EU MDR support for integral drug-device combination products<\/p><\/li><li data-start=\"1039\" data-end=\"1111\"><p data-start=\"1041\" data-end=\"1111\">Audit and inspection readiness support for FDA and Notified Bodies<\/p><\/li><\/ul><p data-start=\"1113\" data-end=\"1331\">With practical experience across both drug and device GMP frameworks, Operon Strategist helps manufacturers ensure safe, effective, and compliant combination products from development through commercialization.<\/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-63410935 elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"63410935\" 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-74a0ec85 exad-glass-effect-no exad-sticky-section-no\" data-id=\"74a0ec85\" 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-2791ced8 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"2791ced8\" 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 Move Your Combination Product Forward?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-72bfcc61 elementor-align-center exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-button\" data-id=\"72bfcc61\" 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-eg\/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\">Get Expert Support<\/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-3d1a46d elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"3d1a46d\" 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-7175e6a exad-glass-effect-no exad-sticky-section-no\" data-id=\"7175e6a\" 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-619a839 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"619a839\" 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-a5062f3 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-shortcode\" data-id=\"a5062f3\" 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 a drug-device combination product?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>A drug-device combination product integrates a medical device with a pharmaceutical ingredient, designed to work together for a combined therapeutic effect, like insulin pens or drug-coated catheters.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-2\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">Why is regulatory documentation important for drug-device combination products?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Proper documentation ensures the product complies with both device and pharmaceutical regulations, confirming its safety, quality, and efficacy for market approval.<\/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 support combination product documentation in Egypt?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Operon Strategist provides end-to-end support including design documentation, risk assessments, validation protocols, and regulatory file preparation for EDA and other international approvals<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-4\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">Which standards apply to drug-device combination product documentation?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Key applicable standards include ISO 13485 for QMS, ISO 14971 for risk management, EU MDR 2017\/745, US FDA 21 CFR Part 4, and Egypt Drug Authority (EDA) regulatory guidelines.<\/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>Drug Device Combination Products What is Drug Device Combination Products? A combination product as indicated by the Code of Federal Regulation, CFR is expressed as a product that includes a medical device \/or a medication\/or a biologic consolidating any two of these classifications and at some point, even every one of the three. The well-known [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":454,"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-455","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/455","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/comments?post=455"}],"version-history":[{"count":8,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/455\/revisions"}],"predecessor-version":[{"id":3022,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/455\/revisions\/3022"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/454"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/media?parent=455"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}