{"id":140151,"date":"2022-04-06T11:15:48","date_gmt":"2022-04-06T11:15:48","guid":{"rendered":"https:\/\/www.capgemini.com\/?page_id=671370"},"modified":"2025-04-02T11:55:21","modified_gmt":"2025-04-02T11:55:21","slug":"software-as-a-medical-device","status":"publish","type":"page","link":"https:\/\/www.capgemini.com\/au-en\/solutions\/software-as-a-medical-device\/","title":{"rendered":"Software as a medical device"},"content":{"rendered":"\n<header class=\"wp-block-cg-blocks-hero-reusable is-style-blue-line header heroReusable  \"><div class=\"header-bgs\"><picture><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/ÎÚÑ»´«Ã½_SOFTWARE-AS-A-MEDICAL-DEVICE.jpg?w=2880&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/ÎÚÑ»´«Ã½_SOFTWARE-AS-A-MEDICAL-DEVICE.jpg?w=2880&amp;quality=70 2x\" media=\"(min-width: 1500px)\"\/><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/ÎÚÑ»´«Ã½_SOFTWARE-AS-A-MEDICAL-DEVICE.jpg?w=1440&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/ÎÚÑ»´«Ã½_SOFTWARE-AS-A-MEDICAL-DEVICE.jpg?w=2880&amp;quality=70 2x\" media=\"(min-width: 992px)\"\/><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/ÎÚÑ»´«Ã½_SOFTWARE-AS-A-MEDICAL-DEVICE.jpg?w=1024&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/ÎÚÑ»´«Ã½_SOFTWARE-AS-A-MEDICAL-DEVICE.jpg?w=1024&amp;quality=70 2x\" media=\"(min-width: 768px)\"\/><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/ÎÚÑ»´«Ã½_SOFTWARE-AS-A-MEDICAL-DEVICE.jpg?w=768&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/ÎÚÑ»´«Ã½_SOFTWARE-AS-A-MEDICAL-DEVICE.jpg?w=768&amp;quality=70 2x\" media=\"(min-width: 0)\"\/><img decoding=\"async\" src=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/ÎÚÑ»´«Ã½_SOFTWARE-AS-A-MEDICAL-DEVICE.jpg\" class=\"header-img header-img-d\" alt=\"\" style=\"object-fit:cover;object-position:60% 65%\" loading=\"eager\"\/><\/picture><\/div><div class=\"heroPictureCardHeaderShape\"><\/div><div class=\"container\"><div class=\"row\"><div class=\"col-md-12\"><div class=\"box\"><div class=\"boxTagWrapper\"><div class=\"tagInfo\"><div><span class=\"box-tag\">Solution<\/span><\/div><\/div><\/div><div class=\"box-title\"><h1 data-maxlength=\"34\">Software as a medical device<\/h1><\/div><div class=\"inner-row-insight download-btn\"><\/div><\/div><\/div><\/div><\/div><\/header>\n\n\n\n<section class=\"wp-block-cg-blocks-intro-para undefined section section--intro\"><div class=\"intro-para\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-md-1\"><nav class=\"article-social\"><ul class=\"social-nav\"><li class=\"ip-order-fb\"><a href=\"https:\/\/www.facebook.com\/sharer\/sharer.php?u=https:\/\/www.capgemini.com\/au-en\/solutions\/software-as-a-medical-device\/\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"opens in a new window\"><i aria-hidden=\"true\" class=\"icon-fb\"><\/i><span class=\"sr-only\">Facebook<\/span><\/a><\/li><li class=\"ip-order-li\"><a href=\"https:\/\/www.linkedin.com\/sharing\/share-offsite\/?url=https:\/\/www.capgemini.com\/au-en\/solutions\/software-as-a-medical-device\/\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"opens in a new window\"><i aria-hidden=\"true\" class=\"icon-li\"><\/i><span class=\"sr-only\">Linkedin<\/span><\/a><\/li><\/ul><\/nav><\/div><div class=\"col-12 col-md-11 col-lg-10\"><h2 class=\"intro-para-title\">Digital health is a rapidly growing market driven by a need for more efficient and cost-effective healthcare, increasingly pushed towards remote monitoring and out of hospital care with the promise of better outcomes through personalized medicine.<\/h2><\/div><\/div><\/div><\/div><\/section>\n\n\n\n<section class=\"wp-block-cg-blocks-group undefined section section--article-content\"><div class=\"article-main-content\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-md-11 col-lg-10 offset-md-1 offset-lg-1\"><div class=\"article-text article-quote-text\">\n<p>Software as a Medical Device (SaMD) is the regulated sub-segment of digital health solutions, including digital therapeutics (DTx).<\/p>\n\n\n\n<p>Industry demands are accelerating convergence of digital health technologies, combining patient centric applications with telehealth and HCP dedicated apps as part of a holistic healthcare ecosystem, but also increasing complexity.<\/p>\n\n\n\n<p>Accelerating technological change has created new ways for providers to engage with patients, creating a need to deliver SaMD solutions quickly to maintain market relevance thereby challenging the traditional business models.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/section>\n\n\n\n<section class=\"wp-block-cg-blocks-intro-para-video section section--info-2cols section--insights section-video is-style-default\"><div class=\"bg-color video-align-left\"><div class=\"container\"><div class=\"row video-align-right\"><div class=\"col-md-12\"><div class=\"video-align-right row box box--4 box--mini\"><div class=\"col-md-1\"><\/div><div class=\"col-md-8 box-img-wrapper\"><div class=\"video-box\"><div class=\"video-wrapper\"><iframe title=\"video-section\" src=\"https:\/\/www.youtube.com\/embed\/0aZ0FDzubEc\" frameborder=\"0\" rel=\"0\" allow=\"accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture\" allowfullscreen><\/iframe><\/div><\/div><\/div><div class=\"col-md-3\"><h3 class=\"Video-title\" data-maxlength=\"34\">Our SaMD framework<\/h3><div class=\"video-info\"><p data-maxlength=\"68\">Secure and flexible foundations for medical apps.<\/p><\/div><\/div><div class=\"col-md-1\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n\n\n\n<section class=\"wp-block-cg-blocks-how-we-do-it section section--howwedoit block-howwedoit\"><div class=\"container\"><div><div class=\"content-title\"><h2 data-maxlength=\"72\" class=\"expandable-heading-tag\">What we do<\/h2><\/div><p><\/p><\/div><div class=\"section-content\">\n<div class=\"wp-block-cg-blocks-card-howwedoit expanders\"><div class=\"box card-regulated-agreements card-howwedoit\"><div class=\"expander-box filter-box tag-active \"><div class=\"expander-title\" tabindex=\"0\" role=\"button\" aria-pressed=\"false\" aria-expanded=\"false\"><h3 class=\"expander-heading-title\">Strategy<\/h3><\/div><div class=\"expander-subtitle\"><p class=\"small-description\">Capture high potential opportunities for sustainable growth<\/p><\/div><div class=\"expander-content\"><p>Understand the market and create value-driven solutions leveraging robust technology to meet business and end-user needs.<\/p><div class=\"bg-color video-align-right\"><div class=\"container\"><div class=\"row video-align-left\"><div class=\"col-md-12\"><div class=\"video-align-left row box box--4 box--mini\"><div class=\"col-md-3\"><\/div><div class=\"col-md-8 box-img-wrapper\"><div class=\"video-box\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"content-more\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-cg-blocks-card-howwedoit expanders\"><div class=\"box card-regulated-agreements card-howwedoit\"><div class=\"expander-box filter-box tag-active \"><div class=\"expander-title\" tabindex=\"0\" role=\"button\" aria-pressed=\"false\" aria-expanded=\"false\"><h3 class=\"expander-heading-title\">User Experience<\/h3><\/div><div class=\"expander-subtitle\"><p class=\"small-description\">Create seamless and engaging user experience ensuring safety and ease-of-use<\/p><\/div><div class=\"expander-content\"><p>Apply best practices in Interaction Design and Human Factors Engineering to engage and support users.<\/p><div class=\"bg-color video-align-right\"><div class=\"container\"><div class=\"row video-align-left\"><div class=\"col-md-12\"><div class=\"video-align-left row box box--4 box--mini\"><div class=\"col-md-3\"><\/div><div class=\"col-md-8 box-img-wrapper\"><div class=\"video-box\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"content-more\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-cg-blocks-card-howwedoit expanders\"><div class=\"box card-regulated-agreements card-howwedoit\"><div class=\"expander-box filter-box tag-active \"><div class=\"expander-title\" tabindex=\"0\" role=\"button\" aria-pressed=\"false\" aria-expanded=\"false\"><h3 class=\"expander-heading-title\">Design and Development<\/h3><\/div><div class=\"expander-subtitle\"><p class=\"small-description\">Accelerate time-to-market with SaMD solutions built to grow with evolving needs<\/p><\/div><div class=\"expander-content\"><p>Framework and certified processes to rapidly design, iterate and maintain compliant, engaging solutions.<\/p><div class=\"bg-color video-align-right\"><div class=\"container\"><div class=\"row video-align-left\"><div class=\"col-md-12\"><div class=\"video-align-left row box box--4 box--mini\"><div class=\"col-md-3\"><\/div><div class=\"col-md-8 box-img-wrapper\"><div class=\"video-box\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"content-more\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-cg-blocks-card-howwedoit expanders\"><div class=\"box card-regulated-agreements card-howwedoit\"><div class=\"expander-box filter-box tag-active \"><div class=\"expander-title\" tabindex=\"0\" role=\"button\" aria-pressed=\"false\" aria-expanded=\"false\"><h3 class=\"expander-heading-title\">IoT and Platform<\/h3><\/div><div class=\"expander-subtitle\"><p class=\"small-description\">Build and scale your capacity to capture and manage medical data.<\/p><\/div><div class=\"expander-content\"><p>Design, customize, deploy platforms for reliability, security, growth and flexibility to meet future needs.<\/p><div class=\"bg-color video-align-right\"><div class=\"container\"><div class=\"row video-align-left\"><div class=\"col-md-12\"><div class=\"video-align-left row box box--4 box--mini\"><div class=\"col-md-3\"><\/div><div class=\"col-md-8 box-img-wrapper\"><div class=\"video-box\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"content-more\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-cg-blocks-card-howwedoit expanders\"><div class=\"box card-regulated-agreements card-howwedoit\"><div class=\"expander-box filter-box tag-active \"><div class=\"expander-title\" tabindex=\"0\" role=\"button\" aria-pressed=\"false\" aria-expanded=\"false\"><h3 class=\"expander-heading-title\">Trusted AI<\/h3><\/div><div class=\"expander-subtitle\"><p class=\"small-description\">AI solutions trusted by HCPs and accepted by regulators<\/p><\/div><div class=\"expander-content\"><p>Unlock value of data with AI solution design, implementation, verification and lifecycle support.<\/p><div class=\"bg-color video-align-right\"><div class=\"container\"><div class=\"row video-align-left\"><div class=\"col-md-12\"><div class=\"video-align-left row box box--4 box--mini\"><div class=\"col-md-3\"><\/div><div class=\"col-md-8 box-img-wrapper\"><div class=\"video-box\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"content-more\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-cg-blocks-card-howwedoit expanders\"><div class=\"box card-regulated-agreements card-howwedoit\"><div class=\"expander-box filter-box tag-active \"><div class=\"expander-title\" tabindex=\"0\" role=\"button\" aria-pressed=\"false\" aria-expanded=\"false\"><h3 class=\"expander-heading-title\">Cybersecurity<\/h3><\/div><div class=\"expander-subtitle\"><p class=\"small-description\">Ensure security by design<\/p><\/div><div class=\"expander-content\"><p>End-to-end system security to manage threats and assure health data compliance.<\/p><div class=\"bg-color video-align-right\"><div class=\"container\"><div class=\"row video-align-left\"><div class=\"col-md-12\"><div class=\"video-align-left row box box--4 box--mini\"><div class=\"col-md-3\"><\/div><div class=\"col-md-8 box-img-wrapper\"><div class=\"video-box\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"content-more\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-cg-blocks-card-howwedoit expanders\"><div class=\"box card-regulated-agreements card-howwedoit\"><div class=\"expander-box filter-box tag-active \"><div class=\"expander-title\" tabindex=\"0\" role=\"button\" aria-pressed=\"false\" aria-expanded=\"false\"><h3 class=\"expander-heading-title\">Legal Manufacturer<\/h3><\/div><div class=\"expander-subtitle\"><p class=\"small-description\">Simplify compliance \u2013 from regulatory strategy to submissions and post-market support<\/p><\/div><div class=\"expander-content\"><p>We can act as Legal Manufacturer to reduce your compliance efforts. We can also help you develop your capability to become Legal Manufacturer and support your immediate regulatory needs.<\/p><div class=\"bg-color video-align-right\"><div class=\"container\"><div class=\"row video-align-left\"><div class=\"col-md-12\"><div class=\"video-align-left row box box--4 box--mini\"><div class=\"col-md-3\"><\/div><div class=\"col-md-8 box-img-wrapper\"><div class=\"video-box\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"content-more\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/section>\n\n\n\n\n<section class=\"section section--expert-perspectives\"><div class=\"container\"><div class=\"content-title\"><h2 class=\"expert-heading\">Expert perspectives<\/h2><\/div><div class=\"expert-prospective-container\"><div class=\"row\"><\/div><\/div><\/div><\/section>\n\n\n<section class=\"wp-block-cg-blocks-wrapper-people-slider section section--expert-slider wrapper-people-slider undefined\"><div class=\"container\"><div class=\"content-title\"><h2 data-maxlength=\"34\" class=\"people-heading-title\">Meet our experts<\/h2><\/div><\/div><div class=\"slider slider-boxed\"><div class=\"container\"><div class=\"slider-window\"><div class=\"slider-list\"><\/div><\/div><\/div><div class=\"slider-nav\"><button class=\"slider-prev inactive\" aria-label=\"Slider-previous\" tabindex=\"-1\"><\/button><ul class=\"slider-paginator\"><\/ul><button class=\"slider-next\" aria-label=\"Slider-next\"><\/button><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":151,"featured_media":140152,"parent":122193,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"cg_dt_proposed_to":[],"cg_seo_hreflang_relations":"[]","cg_seo_canonical_relation":"","cg_seo_hreflang_x_default_relation":"{\"uuid\":\"fc38b8e9-18c5-41a7-91ab-b4132a3857f9\",\"blogId\":\"\",\"domain\":\"\",\"sitePath\":\"\",\"postLink\":\"\",\"postId\":null,\"isSaved\":true,\"isCrossLink\":false,\"hasCrossLink\":false}","cg_dt_approved_content":true,"cg_dt_mandatory_content":false,"cg_dt_notes":"","cg_dg_source_changed":false,"cg_dt_link_disabled":false,"_yoast_wpseo_primary_brand":"","footnotes":"","featured_focal_points":"","partner_card_description":"","gsap_animation":0},"brand":[],"partner_type":[],"service":[],"industry":[],"partners":[],"page-type":[140],"content-group":[],"class_list":["post-140151","page","type-page","status-publish","has-post-thumbnail","hentry","page-type-solutions"],"yoast_head":"<!-- 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