{"id":931,"date":"2025-03-31T16:05:51","date_gmt":"2025-03-31T14:05:51","guid":{"rendered":"https:\/\/cymapp.com\/sectors\/dispositivi-medici\/"},"modified":"2025-07-10T09:49:06","modified_gmt":"2025-07-10T07:49:06","slug":"combination-products","status":"publish","type":"page","link":"https:\/\/cymapp.com\/en\/sectors\/combination-products\/","title":{"rendered":"Combination Products"},"content":{"rendered":"<div class=\"wpb-content-wrapper\" id=\"wpb-content-root\"><p>[vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221; el_class=&#8221;dark-green-section corner-picture-section&#8221; css=&#8221;.vc_custom_1746780219291{padding-top: 140px !important;background-image: url(https:\/\/cymapp.com\/wp-content\/uploads\/2025\/05\/combination-products-20250512.png?id=607) !important;}&#8221; z_index=&#8221;&#8221;][vc_column][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_column_text css=&#8221;&#8221; el_class=&#8221;highlight-bold-text&#8221;]<\/p>\n<h1>Cymapp<sup>\u00ae<\/sup> for<br \/>\n<strong>Combination Products<\/strong><\/h1>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;48px&#8221;][vc_column_text css=&#8221;&#8221; el_class=&#8221;readable-width&#8221;]In a sector characterized by growing regulatory complexity and a focus on patient safety concerning the potential risks associated with device use, Risk Management becomes a crucial element for ensuring <strong>patient safety, regulatory compliance, and economic sustainability<\/strong>.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221; css=&#8221;.vc_custom_1746781175630{padding-top: 140px !important;}&#8221; z_index=&#8221;&#8221;][vc_column][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_single_image image=&#8221;612&#8243; img_size=&#8221;full&#8221; css=&#8221;&#8221; qode_css_animation=&#8221;&#8221;][vc_empty_space height=&#8221;24px&#8221;][vc_column_text css=&#8221;&#8221; el_class=&#8221;readable-width-wider hero-text-1&#8243;]<strong>Pharmaceutical companies<\/strong> that commercialize <strong>combination products<\/strong> often face challenges related to integrating <strong>different regulatory systems<\/strong> (pharmaceutical and medical devices), which must be combined with healthcare responsibilities, particularly in:[\/vc_column_text][vc_empty_space height=&#8221;36px&#8221;][vc_column_text css=&#8221;&#8221; el_class=&#8221;readable-width&#8221;]<\/p>\n<ul>\n<li>Integrating different regulatory standards, such as ICH Q9 for the pharmaceutical component and ISO 14971 for the technological one.<\/li>\n<li>Managing emerging risks throughout the product lifecycle, including those related to the interaction between the medicinal component and the device.<\/li>\n<li>Objectively and traceably demonstrating that the clinical benefits outweigh the residual risks, in a setting with increasingly rigorous audits.<\/li>\n<li>Monitoring the origin of a defect and understanding whether the cause of a malfunction is attributable to the device or the active ingredient, with proactive actions to address it.<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;36px&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner el_class=&#8221;padding_50_mobile&#8221; css=&#8221;.vc_custom_1747060200527{padding-top: 120px !important;padding-bottom: 150px !important;}&#8221;][vc_column_text css=&#8221;&#8221; el_class=&#8221;readable-width-wider-centered hero-text-1 highlight-bold-text&#8221;]<\/p>\n<p style=\"text-align: center;\">These are complex technologies requiring <strong>simultaneous compliance with pharmaceutical and medical device regulations<\/strong>. Often, a fragmented approach to Risk Management leads to redundancies, omissions, or conflicts that emerge only in the advanced stages of development or, worse, during regulatory audits.<\/p>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_raw_html css=&#8221;&#8221;]JTVCc2MlMjBuYW1lJTNEJTIyc2VwYXJhdG9yJTIyJTVEJTVCJTJGc2MlNUQ=[\/vc_raw_html][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_empty_space height=&#8221;24px&#8221;][vc_column_text css=&#8221;&#8221; el_class=&#8221;h2 custom-title-1&#8243;]<\/p>\n<p style=\"text-align: center;\">All advantages<\/p>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;24px&#8221;][vc_column_text css=&#8221;&#8221; el_class=&#8221;p&#8221;]<\/p>\n<h2 style=\"text-align: center;\">Why Combination Product Manufacturers Should Use Cymapp<sup>\u00ae<\/sup><\/h2>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;70px&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; el_class=&#8221;checkbox-list&#8221;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\n<ul>\n<li>Harmonizes ICH Q9 and ISO 14971 in a single operational environment, eliminating redundancies and facilitating document consistency.<\/li>\n<li>Harmonizes ICH Q9 and ISO 14971 in a single operational environment, eliminating redundancies and facilitating document consistency.<\/li>\n<li>Correlates real-time technical risks with clinical impacts on the patient, enabling timely and targeted interventions, both pre-market and post-market.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\n<ul>\n<li>Keeps the risk assessment updated throughout the entire product lifecycle with full traceability, even when post-approval changes and post-marketing surveillance are required.<\/li>\n<li>Facilitates collaboration between multidisciplinary teams through a shared language and intuitive visualization tools.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_empty_space height=&#8221;120px&#8221;][vc_single_image image=&#8221;601&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; css=&#8221;&#8221; qode_css_animation=&#8221;&#8221; el_class=&#8221;animate fade-in-up&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221; el_class=&#8221;dark-green-section overflow-visible&#8221; css=&#8221;.vc_custom_1746697860820{padding-top: 120px !important;}&#8221; z_index=&#8221;&#8221;][vc_column][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_empty_space height=&#8221;24px&#8221;][vc_column_text css=&#8221;&#8221; el_class=&#8221;custom-title-1&#8243;]<\/p>\n<h2 style=\"text-align: center;\">Transform Risk Management<\/h2>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;24px&#8221;][vc_column_text css=&#8221;&#8221; el_class=&#8221;hero-text-1 readable-width-centered&#8221;]<\/p>\n<p style=\"text-align: center;\">The difference between Cymapp<sup>\u00ae<\/sup> and other similar solutions on the pharmaceutical market is substantial<\/p>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;80px&#8221;][\/vc_column_inner][\/vc_row_inner][vc_raw_html css=&#8221;&#8221;]JTVCc2MlMjBuYW1lJTNEJTIyc2VwYXJhdG9yLTIlMjIlNUQlNUIlMkZzYyU1RA==[\/vc_raw_html][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; el_class=&#8221;compare-row compare-row-headings&#8221;][vc_column_inner width=&#8221;1\/5&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDcCUyMGFyaWEtaGlkZGVuJTNEJTIydHJ1ZSUyMiUzRVdpdGglMjBDeW1hcHAlM0NzdXAlM0UlQzIlQUUlM0MlMkZzdXAlM0UlM0MlMkZwJTNF[\/vc_raw_html][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDcCUyMGFyaWEtaGlkZGVuJTNEJTIydHJ1ZSUyMiUzRVdpdGhvdXQlMjBDeW1hcHAlM0NzdXAlM0UlQzIlQUUlM0MlMkZzdXAlM0UlM0MlMkZwJTNF[\/vc_raw_html][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; el_class=&#8221;compare-row compare-row-data&#8221;][vc_column_inner width=&#8221;1\/5&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\n<h3>Simultaneous Compliance<\/h3>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDZGl2JTIwY2xhc3MlM0QlMjJzci1vbmx5JTIyJTNFV2l0aCUyMEN5bWFwcCUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_column_text css=&#8221;&#8221;]Facilitated Generation of Technical Documentation with Continuous Clinical Evaluation Updates and Reduced Preparation Times[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDZGl2JTIwY2xhc3MlM0QlMjJzci1vbmx5JTIyJTNFV2l0aG91dCUyMEN5bWFwcCUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_column_text css=&#8221;&#8221;]Fragmented Documentation, Difficulty in Updating the Technical File[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; el_class=&#8221;compare-row compare-row-data&#8221;][vc_column_inner width=&#8221;1\/5&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\n<h3>Post-Market Surveillance<\/h3>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDZGl2JTIwY2xhc3MlM0QlMjJzci1vbmx5JTIyJTNFV2l0aCUyMEN5bWFwcCUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_column_text css=&#8221;&#8221;]Structured monitoring with immediate integration of feedback into risk analysis and early identification of malfunction patterns.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDZGl2JTIwY2xhc3MlM0QlMjJzci1vbmx5JTIyJTNFV2l0aG91dCUyMEN5bWFwcCUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_column_text css=&#8221;&#8221;]Late detection of emerging problems with difficulty in analyzing post-market clinical data.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; el_class=&#8221;compare-row compare-row-data&#8221;][vc_column_inner width=&#8221;1\/5&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\n<h3>Risk\/Benefit Evaluation<\/h3>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDZGl2JTIwY2xhc3MlM0QlMjJzci1vbmx5JTIyJTNFV2l0aCUyMEN5bWFwcCUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_column_text css=&#8221;&#8221;]Objective parameters for analyzing the risk\/benefit ratio with intuitive visualization of correlations and quantifiable evidence for regulatory authorities.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDZGl2JTIwY2xhc3MlM0QlMjJzci1vbmx5JTIyJTNFV2l0aG91dCUyMEN5bWFwcCUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_column_text css=&#8221;&#8221;]Subjective analysis with difficulty in correlating thousands of technical and clinical data points.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; el_class=&#8221;compare-row compare-row-data&#8221;][vc_column_inner width=&#8221;1\/5&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\n<h3>Corrective actions management<\/h3>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDZGl2JTIwY2xhc3MlM0QlMjJzci1vbmx5JTIyJTNFV2l0aCUyMEN5bWFwcCUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_column_text css=&#8221;&#8221;]Intelligent prioritization of corrective actions.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/5&#8243;][vc_raw_html css=&#8221;&#8221;]JTNDZGl2JTIwY2xhc3MlM0QlMjJzci1vbmx5JTIyJTNFV2l0aG91dCUyMEN5bWFwcCUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_column_text css=&#8221;&#8221;]Manual tracking with delays in implementation due to documents being lost within the company.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; 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