{"id":46,"date":"2022-11-01T12:49:02","date_gmt":"2022-11-01T12:49:02","guid":{"rendered":"https:\/\/operonstrategist.com\/southafrica\/?page_id=46"},"modified":"2024-08-09T04:07:53","modified_gmt":"2024-08-09T04:07:53","slug":"drug-device-combination-products","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-za\/services\/regulatory-approvals\/drug-device-combination-products\/","title":{"rendered":"DRUG DEVICE COMBINATION PRODUCTS"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"46\" class=\"elementor elementor-46\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-31eec836 banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"31eec836\" 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-702cc863\" data-id=\"702cc863\" 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-7435c175 banner-sec-heading elementor-widget elementor-widget-heading\" data-id=\"7435c175\" 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\">Drug 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-75ef9abd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"75ef9abd\" 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-77d5aaf9\" data-id=\"77d5aaf9\" 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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-388b5599 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"388b5599\" data-element_type=\"section\" data-e-type=\"section\">\n\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-inner-column elementor-element elementor-element-7dd93482\" data-id=\"7dd93482\" 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-2aad4015 elementor-widget elementor-widget-heading\" data-id=\"2aad4015\" 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\">Drug Device Combination Products FDA Guidance<\/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-inner-section elementor-element elementor-element-15a449d elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"15a449d\" data-element_type=\"section\" data-e-type=\"section\">\n\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-50 elementor-inner-column elementor-element elementor-element-4a4d3238\" data-id=\"4a4d3238\" 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-168fc593 elementor-widget elementor-widget-text-editor\" data-id=\"168fc593\" 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 combination product, as defined by the Code of Federal Regulations (CFR), is a product that integrates a medical device, a medication, or a biologic, combining any two of these categories, and sometimes all three. A well-known example of a combination product is the drug-eluting stent (DES), which is a scaffold coated with a drug to prevent scar tissue from forming in the artery. Many people have a limited understanding of combination products, often associating them solely with drug-device combinations. However, the scope of combination products has expanded significantly and now includes not only drugs, devices, and biologics but also foods, nutraceuticals, and cosmetic agents, sometimes referred to as cosmeceuticals. When a drug is combined with a device, it is classified as a drug-device combination.<\/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-inner-column elementor-element elementor-element-156f501f\" data-id=\"156f501f\" 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-483674ca elementor-widget elementor-widget-image\" data-id=\"483674ca\" 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-za\/wp-content\/uploads\/2022\/11\/DESIGN-DEVELOPMENT-CONSULTANT-COMBINATION-PRODUCT.jpg\" class=\"attachment-full size-full wp-image-341\" alt=\"\" srcset=\"https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/DESIGN-DEVELOPMENT-CONSULTANT-COMBINATION-PRODUCT.jpg 1200w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/DESIGN-DEVELOPMENT-CONSULTANT-COMBINATION-PRODUCT-300x157.jpg 300w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/DESIGN-DEVELOPMENT-CONSULTANT-COMBINATION-PRODUCT-1024x536.jpg 1024w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/DESIGN-DEVELOPMENT-CONSULTANT-COMBINATION-PRODUCT-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<div class=\"elementor-element elementor-element-77b491b4 elementor-widget elementor-widget-text-editor\" data-id=\"77b491b4\" 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\">As per the FDA combination product, types of combination products can be,<\/span><\/p><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">\u00a0single entity,<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&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;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">\u00a0cross labeled, <\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&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;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">co-packaged.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><\/ul><p><span data-contrast=\"none\">Combination Products\u202fexamples like prefilled syringes, and applicators of tropical products. Manufacturers should have adequate\u202fdesign and development activity done to prove the adequacy of the safety and efficacy of the product. The <\/span><span data-contrast=\"auto\">medical device design and development<\/span><span data-contrast=\"none\"> activity is the systematic methodology, which establishes the proper design and development of the products. Many of the customer complaints and 483s in the case of medical devices or combination devices are attributed to improper design and development control activity. The design and development requirements of the product are described in\u202f<\/span><a href=\"https:\/\/operonstrategist.com\/en-za\/services\/turnkey-project\/quality-management-system\/iso-13485\/\"><span data-contrast=\"none\">ISO 13485:2016<\/span><\/a><span data-contrast=\"none\">\u202fand <a href=\"https:\/\/operonstrategist.com\/en-za\/services\/turnkey-project-consultants\/quality-management-system\/fda-21-cfr-part820\/\">21 CFR Part 820<\/a> also. <\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-16f8c762 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"16f8c762\" 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-50 elementor-top-column elementor-element elementor-element-42b44880\" data-id=\"42b44880\" 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-1573de3a elementor-widget elementor-widget-heading\" data-id=\"1573de3a\" 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? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13aac945 elementor-widget elementor-widget-text-editor\" data-id=\"13aac945\" 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>The Pharmaceutical organization that manufacturers the combination products is expected to implement the <a href=\"https:\/\/operonstrategist.com\/en-za\/services\/turnkey-project-consultants\/quality-management-system\/fda-21-cfr-part820\/\">21 CFR Part 210<\/a> and 211 and 21 CFR Part 820 for their manufacturing sites of the combination products. At the end of the design Phases, the DHF is compiled and shall be presented during the audits. 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 routine production and compliance. As per the requirements of ISO 13485:2016, the medical device file shall be established. The complexity of the design procedure is dependent on the Product&#8217;s complexity and intended use. Design control is a vital part as far as the Quality Management System. <span class=\"TextRun SCXW204177916 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW204177916 BCX0\">Our team makes hard efforts to implement a proper QMS system<\/span><span class=\"NormalTextRun SCXW204177916 BCX0\"> for the manufacturers of <span data-contrast=\"none\">South Africa<\/span><\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW204177916 BCX0\">.<\/span><\/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-49796f8\" data-id=\"49796f8\" 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-394a199 elementor-widget elementor-widget-heading\" data-id=\"394a199\" 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\">Looking For Medical Device Regulatory Consultants?<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2824f3a elementor-widget elementor-widget-wpforms\" data-id=\"2824f3a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-2867\"><form id=\"wpforms-form-2867\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"2867\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/en-za\/wp-json\/wp\/v2\/pages\/46\" data-token=\"24e85eb8ecf3fffdd42ac6ed3bfd9d67\" data-token-time=\"1776021058\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-2867-field_0-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"0\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_0\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-2867-field_0\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][0]\" placeholder=\"Name\" aria-errormessage=\"wpforms-2867-field_0-error\" required><\/div><div id=\"wpforms-2867-field_3-container\" class=\"wpforms-field wpforms-field-number\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"number\" id=\"wpforms-2867-field_3\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][3]\" placeholder=\"Phone\" step=\"any\" aria-errormessage=\"wpforms-2867-field_3-error\" required><\/div><div id=\"wpforms-2867-field_1-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_1\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-2867-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Email\" spellcheck=\"false\" aria-errormessage=\"wpforms-2867-field_1-error\" required><\/div><div id=\"wpforms-2867-field_2-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_2\" aria-hidden=\"false\">Comment or Message <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-2867-field_2\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Message\" aria-errormessage=\"wpforms-2867-field_2-error\" required><\/textarea><\/div><div id=\"wpforms-2867-field_4-container\" class=\"wpforms-field wpforms-field-select wpforms-field-select-style-classic\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_4\" aria-hidden=\"false\">From where do you hear about us?<\/label><select id=\"wpforms-2867-field_4\" class=\"wpforms-field-large\" name=\"wpforms[fields][4]\"><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=\"Shows\/Exhibitions\"  class=\"choice-4 depth-1\"  >Shows\/Exhibitions<\/option><option value=\"Print Advertisements\"  class=\"choice-5 depth-1\"  >Print Advertisements<\/option><option value=\"Other\"  class=\"choice-6 depth-1\"  >Other<\/option><\/select><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"2867\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/46\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-2867\" 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-za\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\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-690486ce elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"690486ce\" 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-3f490373\" data-id=\"3f490373\" 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-1510129 elementor-widget elementor-widget-heading\" data-id=\"1510129\" 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\">Drug-Device Combination (DDC) as per MDR for CE Marking<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31da7083 elementor-widget elementor-widget-text-editor\" data-id=\"31da7083\" 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>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).<\/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-191588f2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"191588f2\" 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-3077ebf9\" data-id=\"3077ebf9\" 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-3f1198b0 elementor-widget elementor-widget-heading\" data-id=\"3f1198b0\" 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\">Generally, These Devices Have Measuring, Metering or Delivery Functions.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f4ce163 elementor-widget elementor-widget-heading\" data-id=\"3f4ce163\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Examples of medical devices in integral DDCs are:<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-40a5bf9 elementor-widget elementor-widget-text-editor\" data-id=\"40a5bf9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">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><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Single-dose pre-filled syringes, pens and injectors.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">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><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Drug-releasing intra-uterine devices; pre-assembled, non-reusable applicators for vaginal tablets.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">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><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Implants containing medicinal products whose primary purpose is to release the medicinal product.<\/span><\/li><\/ul>\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-6b0c23d8 elementor-widget elementor-widget-heading\" data-id=\"6b0c23d8\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Examples of medical devices in integral DDCs are:<\/h5>\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-233ed64 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"233ed64\" 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-inner-column elementor-element elementor-element-63f9aeb\" data-id=\"63f9aeb\" 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-8835796 elementor-widget elementor-widget-text-editor\" data-id=\"8835796\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Oral administration devices (e.g. cups, spoons, syringes)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Injection needles and filter needles<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Refillable pens and injectors (e.g. using cartridges).<\/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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-923b79e\" data-id=\"923b79e\" 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-308a181 elementor-widget elementor-widget-text-editor\" data-id=\"308a181\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Reusable dry powder inhalers; spacers for inhalation sprays<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pumps for medicinal product delivery<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Electronic tablet dispensers<\/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\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-11de506d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"11de506d\" 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-50402b14\" data-id=\"50402b14\" 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-1d453ba5 elementor-widget elementor-widget-heading\" data-id=\"1d453ba5\" 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\">Each Manufacturer of a Medical Device  in South Africa or all over the globe Shall Establish and Maintain the Following Procedures <\/h2>\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-227f73c9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"227f73c9\" 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-inner-column elementor-element elementor-element-72dfa809\" data-id=\"72dfa809\" 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-4408aa1 elementor-widget elementor-widget-text-editor\" data-id=\"4408aa1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Control the design of the device<\/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-inner-column elementor-element elementor-element-6d491ccc\" data-id=\"6d491ccc\" 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-5ac0795 elementor-widget elementor-widget-text-editor\" data-id=\"5ac0795\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Ensure that specified design requirements are met<\/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\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-36ede9f5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"36ede9f5\" 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-6babf3c6\" data-id=\"6babf3c6\" 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-38d6f9a1 elementor-widget elementor-widget-heading\" data-id=\"38d6f9a1\" 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?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-731c0673 elementor-widget elementor-widget-text-editor\" data-id=\"731c0673\" 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>CAPA management of drugs and device combination products are as follow:<\/p><p><strong>To ensure that devices meet a requirement of Combination Products<\/strong><\/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-5e6f91e0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5e6f91e0\" 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-inner-column elementor-element elementor-element-4b80a8bf\" data-id=\"4b80a8bf\" 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-ee6897c elementor-widget elementor-widget-text-editor\" data-id=\"ee6897c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Users\u2019 needs and intended uses<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Requirements and Specifications<\/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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-19958111\" data-id=\"19958111\" 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-cdfcbcd elementor-widget elementor-widget-text-editor\" data-id=\"cdfcbcd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The regulatory pathway for combination products<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Can be reproducibly and reliably manufactured, serviced and\/or installed.<\/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\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-2ca4e63f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2ca4e63f\" 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-4584ea9e\" data-id=\"4584ea9e\" 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-29600d68 elementor-widget elementor-widget-heading\" data-id=\"29600d68\" 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\">Tools for Archiving Purpose of Combination Products<\/h2>\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-68bb74e2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"68bb74e2\" 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-inner-column elementor-element elementor-element-40293d3e\" data-id=\"40293d3e\" 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-f4cc6dd elementor-widget elementor-widget-text-editor\" data-id=\"f4cc6dd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Establish design control procedures.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Develop plans for Design Projects(Include interfaces between R&amp;D and other units)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identify design inputs requirements and high-level specifications for the device<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Develop design outputs (to final specifications)<\/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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-100c058e\" data-id=\"100c058e\" 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-9872911 elementor-widget elementor-widget-text-editor\" data-id=\"9872911\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Design Verification through measurement, analysis, test or inspection that all design outputs fulfil input requirements.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Transfer outputs to production<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Design Validation that the device performs and functions as intended and as users need an expert.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Control changes during design and development and to existing devices Document design activities in the design history file.<\/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<div class=\"elementor-element elementor-element-61d4e30 elementor-widget elementor-widget-text-editor\" data-id=\"61d4e30\" 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>Operon Strategist as a reliable medical device consultant assists companies and medical device manufacturers in <span data-contrast=\"none\">South Africa<\/span>, by 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). We also provide medical device consultation for <a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/design-and-development-documentation\/drug-device-combination-products\/\" target=\"_blank\" rel=\"noopener\">India,<\/a>\u00a0<a href=\"https:\/\/operonstrategist.com\/en-sa\/services\/regulatory-approvals\/design-and-development-documentation\/drug-device-combination-products\/\" target=\"_blank\" rel=\"noopener\">Saudi Arabia<\/a>, <a href=\"https:\/\/operonstrategist.com\/en-cr\/\">Costa Rica<\/a>, <a href=\"https:\/\/us.operonstrategist.com\/\">The USA<\/a>, <a href=\"https:\/\/operonstrategist.com\/en-gb\/\">The UK<\/a>, <a href=\"https:\/\/operonstrategist.com\/en-om\/\">Oman<\/a>, <a href=\"https:\/\/operonstrategist.com\/en-ir\/\">Iran<\/a> &amp; <a href=\"https:\/\/operonstrategist.com\/en-eg\/\" target=\"_blank\" rel=\"noopener\">Egypt<\/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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Drug Device Combination Products Drug Device Combination Products FDA Guidance A combination product, as defined by the Code of Federal Regulations (CFR), is a product that integrates a medical device, a medication, or a biologic, combining any two of these categories, and sometimes all three. A well-known example of a combination product is the drug-eluting [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":20,"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":""}},"_vp_format_video_url":"","_vp_image_focal_point":[],"footnotes":""},"class_list":["post-46","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/46","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/comments?post=46"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/46\/revisions"}],"predecessor-version":[{"id":3330,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/46\/revisions\/3330"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/20"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/media?parent=46"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}