{"id":46,"date":"2022-11-01T12:49:02","date_gmt":"2022-11-01T12:49:02","guid":{"rendered":"https:\/\/operonstrategist.com\/costarica\/?page_id=46"},"modified":"2025-09-16T05:24:17","modified_gmt":"2025-09-16T05:24:17","slug":"drug-device-combination-products","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/design-development-documentation\/drug-device-combination-products\/","title":{"rendered":"Drug Device Combination Product Consultant in Brazil"},"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 Product Consultant in Brazil<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ea27fec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ea27fec\" 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-3313094\" data-id=\"3313094\" 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-33b0efd elementor-widget elementor-widget-heading\" data-id=\"33b0efd\" 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\">Expert Consultation for 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-39ab750 elementor-widget elementor-widget-text-editor\" data-id=\"39ab750\" 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>At Operon Strategist, we provide specialized consultancy for drug device combination products, helping manufacturers navigate complex regulatory requirements and streamline project execution. Our team offers end-to-end support including risk management, design control, <a href=\"https:\/\/operonstrategist.com\/correction-vs-corrective-action-vs-preventive-action-capa-differences-and-best-practices\/\">CAPA<\/a> management, and compliance with EU MDR, <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/anvisa-medical-device-registration-in-brazil\/\">ANVISA,<\/a> and <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/fda-510-k\/\">FDA regulations,<\/a> tailored to the specific needs of your product. With our guidance, you can confidently enter local and global markets while ensuring product safety and efficacy.<\/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-551d68d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"551d68d\" 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-64a90f3\" data-id=\"64a90f3\" 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-d49543d elementor-widget elementor-widget-heading\" data-id=\"d49543d\" 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 Are Drug-Device Combination Products?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2d2621c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2d2621c\" 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-241f08b\" data-id=\"241f08b\" 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-c566a57 elementor-widget elementor-widget-text-editor\" data-id=\"c566a57\" 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=\"889\" data-end=\"1238\">Drug-device combination products are innovative healthcare solutions that combine a drug, device, biologic, or a mix of these components into a single product or system. Defined <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/fda-21-cfr-part-820-quality-system-regulation\/\">under 21 CFR<\/a> 3.2(e), these products deliver therapeutic or diagnostic functions, improving treatment effectiveness and patient outcomes. Common examples include:<\/p><ul><li data-start=\"1241\" data-end=\"1261\">Prefilled syringes<\/li><li data-start=\"1264\" data-end=\"1285\">Drug-eluting stents<\/li><li data-start=\"1288\" data-end=\"1309\">Dry powder inhalers<\/li><li data-start=\"1312\" data-end=\"1352\">Pen injectors for prefilled cartridges<\/li><\/ul><p data-start=\"1354\" data-end=\"1500\">These products are expanding into nutraceuticals and cosmeceuticals, highlighting the growing complexity and innovation in combination products.<\/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-36239f9\" data-id=\"36239f9\" 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-br\/wp-content\/uploads\/2022\/11\/DESIGN-DEVELOPMENT-CONSULTANT-COMBINATION-PRODUCT.jpg\" class=\"attachment-full size-full wp-image-341\" alt=\"drug-device combination products\" srcset=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/DESIGN-DEVELOPMENT-CONSULTANT-COMBINATION-PRODUCT.jpg 1200w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/DESIGN-DEVELOPMENT-CONSULTANT-COMBINATION-PRODUCT-300x157.jpg 300w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2022\/11\/DESIGN-DEVELOPMENT-CONSULTANT-COMBINATION-PRODUCT-1024x536.jpg 1024w, https:\/\/operonstrategist.com\/en-br\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d4127a8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d4127a8\" 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-a3780c8\" data-id=\"a3780c8\" 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-c0b1af1 elementor-widget elementor-widget-heading\" data-id=\"c0b1af1\" 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 Product Development &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-2e4b045 elementor-widget elementor-widget-text-editor\" data-id=\"2e4b045\" 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=\"2101\" data-end=\"2285\">Developing a drug device combination product requires compliance with 21 CFR Part 210\/211 (drugs),<a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/fda-21-cfr-part-820-quality-system-regulation\/\"> 21 CFR Part 820<\/a> (devices), and <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/iso-13485-qms-medical-device\/\">ISO 13485<\/a>:2016 standards. Key steps include:<\/p><ul data-start=\"2286\" data-end=\"2581\"><li data-start=\"2286\" data-end=\"2333\"><p data-start=\"2288\" data-end=\"2333\">Establishing <a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/design-history-file-dhf-for-medical-devices\/\">Design History Files<\/a> (DHF)<\/p><\/li><li data-start=\"2334\" data-end=\"2415\"><p data-start=\"2336\" data-end=\"2415\">Creating Device Master Records (DMR) and Device History Records (DHR)<\/p><\/li><li data-start=\"2416\" data-end=\"2469\"><p data-start=\"2418\" data-end=\"2469\">Implementing robust Design Control procedures<\/p><\/li><li data-start=\"2470\" data-end=\"2523\"><p data-start=\"2472\" data-end=\"2523\">Performing Design Verification and Validation<\/p><\/li><li data-start=\"2524\" data-end=\"2581\"><p data-start=\"2526\" data-end=\"2581\">Managing <a href=\"https:\/\/operonstrategist.com\/correction-vs-corrective-action-vs-preventive-action-capa-differences-and-best-practices\/\">Corrective and Preventive Actions<\/a> (CAPA)<\/p><\/li><\/ul><p data-start=\"2583\" data-end=\"2850\">A properly controlled design process ensures safety, regulatory compliance, and reliable product performance. Many quality issues and FDA 483 observations are linked to inadequate design and development control, highlighting the importance of professional guidance.<\/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-3209d6f\" data-id=\"3209d6f\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&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-e6d9009 elementor-widget-tablet__width-initial elementor-widget elementor-widget-heading\" data-id=\"e6d9009\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Let's Grow Your Business 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src=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/plugins\/wpforms-lite\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8ba21f1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8ba21f1\" 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-5b3a73f\" data-id=\"5b3a73f\" 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-9a7ae76 elementor-widget elementor-widget-heading\" data-id=\"9a7ae76\" 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\">Types of 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-d44be14 elementor-widget elementor-widget-text-editor\" data-id=\"d44be14\" 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=\"1554\" data-end=\"1618\">The FDA classifies combination products into three main types:<\/p><ol data-start=\"1620\" data-end=\"2028\"><li data-start=\"1620\" data-end=\"1740\"><p data-start=\"1623\" data-end=\"1740\"><strong data-start=\"1623\" data-end=\"1650\">Single-Entity Products:<\/strong> Integrated drug and device in one unit (e.g., prefilled syringes, drug-eluting stents).<\/p><\/li><li data-start=\"1741\" data-end=\"1857\"><p data-start=\"1744\" data-end=\"1857\"><strong data-start=\"1744\" data-end=\"1769\">Co-Packaged Products:<\/strong> Drug and device packaged together for combined use (e.g., vaccine vial with syringe).<\/p><\/li><li data-start=\"1858\" data-end=\"2028\"><p data-start=\"1861\" data-end=\"2028\"><strong data-start=\"1861\" data-end=\"1888\">Cross-Labeled Products:<\/strong> Separately packaged components intended for joint use, with combined labeling instructions (e.g., a drug with a dedicated infusion pump).<\/p><\/li><\/ol>\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\">Drug-Device Combination (DDC) Products 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-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\">Integral Drug-Device Combination Products (DDCs)<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20d49e8 elementor-widget elementor-widget-text-editor\" data-id=\"20d49e8\" 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 where the drug and device are physically combined into a single unit, not meant to be separated by the end user. These systems are designed and manufactured to function as a unified solution for precise drug delivery.<\/p><p data-start=\"517\" data-end=\"564\"><strong data-start=\"517\" data-end=\"562\">Examples of integral DDC devices include:<\/strong><\/p><ul><li data-start=\"567\" data-end=\"625\">Droppers on eye drop containers or spray can mouthpieces<\/li><li data-start=\"628\" data-end=\"681\">Single-dose prefilled syringes, pens, and injectors<\/li><li data-start=\"684\" data-end=\"733\">Multi-dose pens with non-replaceable cartridges<\/li><li data-start=\"736\" data-end=\"804\">Drug-releasing intrauterine devices with pre-assembled applicators<\/li><li data-start=\"807\" data-end=\"863\">Dry powder inhalers ready for single or multiple doses<\/li><li data-start=\"866\" data-end=\"915\">Implants designed to release medicinal products<\/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\">Non-Integral Drug-Device Combination Products<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7ddb49f elementor-widget elementor-widget-text-editor\" data-id=\"7ddb49f\" 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=\"969\" data-end=\"1207\">Non-integral DDCs consist of separable components, such as a drug and a device, that are co-packaged or cross-labeled for joint use. While the components work together, they are not physically combined and may be reusable or refillable.<\/p><p data-start=\"1209\" data-end=\"1260\"><strong data-start=\"1209\" data-end=\"1258\">Examples of non-integral DDC devices include:<\/strong><\/p><ul><li data-start=\"1263\" data-end=\"1317\">Oral administration devices (cups, spoons, syringes)<\/li><li data-start=\"1320\" data-end=\"1350\">Injection and filter needles<\/li><li data-start=\"1353\" data-end=\"1384\">Refillable pens and injectors<\/li><li data-start=\"1387\" data-end=\"1440\">Reusable dry powder inhalers and inhalation spacers<\/li><li data-start=\"1443\" data-end=\"1477\">Medicinal product delivery pumps<\/li><li data-start=\"1480\" data-end=\"1510\">Electronic tablet dispensers<\/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-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\">Design Control &amp; 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-b4ef8ac elementor-widget elementor-widget-text-editor\" data-id=\"b4ef8ac\" 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=\"1580\" data-end=\"1711\">To ensure safety, effectiveness, and regulatory compliance, manufacturers of drug device combination products must implement:<\/p><ul><li data-start=\"1714\" data-end=\"1831\"><strong data-start=\"1714\" data-end=\"1743\">Design control procedures<\/strong>: Define inputs, outputs, verification, validation, and design transfer to production.<\/li><li data-start=\"1834\" data-end=\"1975\"><strong data-start=\"1834\" data-end=\"1877\">Corrective and Preventive Action (CAPA)<\/strong>: Systematically identify, correct, and prevent quality issues throughout the product lifecycle.<\/li><\/ul><p data-start=\"1977\" data-end=\"2201\">These processes ensure that combination products meet user needs, regulatory requirements, and reproducible manufacturing standards. All design activities should be properly documented in the Design History File (DHF).<\/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-4a16c17a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4a16c17a\" 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-6751bc78\" data-id=\"6751bc78\" 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-b76b3e4 elementor-widget elementor-widget-heading\" data-id=\"b76b3e4\" 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 bring your drug-device combination product to market?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3a30917a elementor-align-center elementor-widget elementor-widget-button\" data-id=\"3a30917a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/operonstrategist.com\/en-br\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Click here<\/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-6f4066c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6f4066c\" 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-4dfe04f\" data-id=\"4dfe04f\" 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-c0206cc elementor-widget elementor-widget-heading\" data-id=\"c0206cc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why Choose Operon Strategist?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a877de7 elementor-widget elementor-widget-text-editor\" data-id=\"a877de7\" 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=\"2243\" data-end=\"2376\">Operon Strategist provides expert consulting for drug device combination products in Brazil and globally. Our services include:<\/p><ul><li data-start=\"2379\" data-end=\"2453\">Regulatory compliance with <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/fda-21-cfr-part-820-quality-system-regulation\/\">21 CFR Part 820<\/a>, Part 210\/211 and Part 4<\/li><li data-start=\"2456\" data-end=\"2498\">End-to-end design control implementation<\/li><li data-start=\"2501\" data-end=\"2534\">CAPA management and <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/quality-management-system\/\">QMS support<\/a><\/li><li data-start=\"2537\" data-end=\"2589\">Guidance for <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/ce-marking\/\">CE marking<\/a>,<a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/fda-510-k\/\"> FDA,<\/a> and <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/anvisa-medical-device-registration-in-brazil\/\">ANVISA<\/a> approvals<\/li><\/ul><p data-start=\"2591\" data-end=\"2758\">With our experience and structured methodology, we help manufacturers develop safe, effective, and compliant combination products while ensuring smooth market entry.<\/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-b888c1f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b888c1f\" 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-b36a827\" data-id=\"b36a827\" 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-3db84bb elementor-widget elementor-widget-heading\" data-id=\"3db84bb\" 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-b54af05 elementor-widget elementor-widget-shortcode\" data-id=\"b54af05\" 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>It integrates two or more regulated components, such as a drug and a medical device, into a single system. Examples include pre-filled syringes, drug-eluting stents, and inhalers.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-2\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">Are combination products regulated differently from drugs or devices?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Yes, they must comply with both drug (21 CFR Part 210\/211) and device (21 CFR Part 820) regulations depending on the primary mode of action.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-3\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">What documentation is required?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and the Medical Device File per ISO 13485:2016.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-4\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">What is CAPA management?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>CAPA ensures defects or process deviations are identified, corrected, and prevented, maintaining compliance and quality.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-5\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">How does Operon Strategist help manufacturers in Brazil?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>We provide expert consulting on registration, design control, CAPA management, QMS implementation, and regulatory compliance for drug-device combination products.<\/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 Product Consultant in Brazil Expert Consultation for Drug-Device Combination Products At Operon Strategist, we provide specialized consultancy for drug device combination products, helping manufacturers navigate complex regulatory requirements and streamline project execution. Our team offers end-to-end support including risk management, design control, CAPA management, and compliance with EU MDR, ANVISA, and FDA [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":341,"parent":22,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-46","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/46","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/comments?post=46"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/46\/revisions"}],"predecessor-version":[{"id":3839,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/46\/revisions\/3839"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/22"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media\/341"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media?parent=46"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}