{"id":524578,"date":"2024-07-03T10:35:09","date_gmt":"2024-07-03T10:35:09","guid":{"rendered":"https:\/\/www.capgemini.com\/mx-es\/?p=524578&#038;preview=true&#038;preview_id=524578"},"modified":"2025-04-03T17:31:43","modified_gmt":"2025-04-03T17:31:43","slug":"940858-2","status":"publish","type":"post","link":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/","title":{"rendered":"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b"},"content":{"rendered":"\n<p>\u200b<\/p>\n\n\n\n<header class=\"wp-block-cg-blocks-hero-blogs header-hero-blogs\"><div class=\"container\"><div class=\"hero-blogs\"><div class=\"hero-blogs-content-wrapper\"><div class=\"row\"><div class=\"col-12\"><div class=\"header-title\"><h1>How a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b<\/h1><\/div><\/div><\/div><\/div><div class=\"hero-blogs-bottom\"><div class=\"header-author\"><div class=\"author-img\"><img decoding=\"async\" src=\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2021\/08\/cg-logo-3.png?w=200&amp;quality=10\" alt=\"\" loading=\"lazy\"\/><\/div><div class=\"author-name-date\"><h5 class=\"author-name\">ÎÚÑ»´«Ã½<\/h5><h5 class=\"blog-date\">27 Jul 2023<\/h5><\/div><\/div><div class=\"brand-image\"><img decoding=\"async\" loading=\"lazy\" src=\"\/wp-content\/themes\/capgemini2020\/assets\/images\/capgemini-engineering-white.svg\" alt=\"capgemini-engineering\"\/><\/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\/mx-es\/insights\/expert-perspectives\/940858-2\/\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"abrir en una nueva ventana\"><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\/mx-es\/insights\/expert-perspectives\/940858-2\/\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"abrir en una nueva ventana\"><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\">In the field of healthcare systems\u00a0compliance, the difference between 99% and 100% is a chasm.\u00a0\u00a0\u200b\u00a0<\/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>\u201cSoftware defect.\u201d \u201cFalse upstream alarms.\u201d \u201cFirmware error.\u201d \u201cLogin error.\u201d \u201cSoftware bug.\u201d \u201cSensor failure.\u201d \u201cCybersecurity vulnerability.\u201d The FDA list of&nbsp;<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfres\/res.cfm\" target=\"_blank\" rel=\"noreferrer noopener\">software-related&nbsp;recalls<\/a>&nbsp;is sobering reading. We see the story behind each event \u2013 the teams that worked overtime designing and building a new device, quality assurance professionals checking&nbsp;each and every&nbsp;vulnerability, last-minute adjustments, the elation of a seemingly successful release\u2026 And all the while a tiny flaw lay hidden from sight, with the power to&nbsp;derail everything compromising safety and&nbsp;exposing liabilities.&nbsp;\u200b<\/p>\n\n\n\n<p>As a <a href=\"https:\/\/www.capgemini.com\/solutions\/capgemini-as-your-legal-manufacturer-for-samd\/\">legal manufacturer<\/a>, we specialize in safety and compliance for Software as a Medical Device (SaMD). It\u2019s a fast-growing field, with risks hiding in every nook and cranny.&nbsp;How do we make sure we catch and neutralize every risk? How do we ensure safety and compliance, without sacrificing speed? Let\u2019s dive in.&nbsp;\u200b<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Compliance&nbsp;and agility by design\u200b<\/h3>\n\n\n\n<p>There\u2019s a common fear that&nbsp;<a href=\"https:\/\/www.google.com\/url?sa=t&amp;rct=j&amp;q=&amp;esrc=s&amp;source=web&amp;cd=&amp;cad=rja&amp;uact=8&amp;ved=2ahUKEwjxmfqb1ZqAAxVaJRAIHUCNBfIQFnoECA0QAQ&amp;url=https%3A%2F%2Fwww.capgemini.com%2Fus-en%2Fsolutions%2Fregulatory-affairs-compliance-and-quality%2F&amp;usg=AOvVaw19dPeb4ry8An6i_HpvzuVR&amp;opi=89978449\" target=\"_blank\" rel=\"noreferrer noopener\">safety and compliance<\/a>&nbsp;slow&nbsp;down go to market. A justified concern? Yes and no. Of course, extra steps take extra time. That\u2019s why, wherever&nbsp;possible, we work to engrain safety and compliance considerations into every process. For example, a remote patient monitoring system that records patient data needs to do&nbsp;many things, some are basic functions; others cross over into the \u201csafety\u201d category.&nbsp;Safety and compliance are mandatory and are integrated into the development process.&nbsp;Pharma and MedTech companies will&nbsp;speed development and improve quality if they adopt two changes: agile processes combined with modularity by design. To see how&nbsp;modularity adds value, let\u2019s look closer at the challenges&nbsp;SaMD&nbsp;teams face.\u200b<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-challenges-of-connected-systems-nbsp\">Challenges of connected systems&nbsp;\u200b<\/h3>\n\n\n\n<p>With today&#8217;s more connected and complex systems, the boundaries of what constitutes \u201cSoftware as a Medical Device\u201d are often blurred. For example, when the system is&nbsp;distributed, with parts of an application running on a wearable,&nbsp;mobile phone, or in the cloud, and&nbsp; a combination of medical and non-medical functions, is the whole system&nbsp;SaMD? How do we manage&nbsp;a combination of&nbsp;safety and non-safety, administrative and&nbsp;other&nbsp;functions that&nbsp;all need to work together to fulfill a medical purpose? If&nbsp;the system&nbsp;is&nbsp;developed as monolithic, this&nbsp;increases effort to get regulatory approval and places additional compliance effort to modify, improve or add functions after the system has&nbsp;received initial market authorization. What\u2019s the solution?\u200b<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">The benefits of modularization&nbsp;for connected health&nbsp;\u200b<\/h3>\n\n\n\n<p>A pragmatic approach to accelerate&nbsp;SaMD&nbsp;development, manage safety and regulatory complexity, and&nbsp;maintain flexibility, is modularization. We segregate&nbsp;SaMD&nbsp;products&nbsp;by&nbsp;function and by risk category (high, medium and low risk). This makes it possible to apply the&nbsp;appropriate level of risk control and&nbsp;testing measures in each case. Using&nbsp;pre-built,&nbsp;ready-to-use&nbsp;SaMD&nbsp;modules&nbsp;developed under certified processes and&nbsp;qualified tools,&nbsp;assures reliable, fast and&nbsp;compliant&nbsp;software.&nbsp;\u200b<\/p>\n\n\n\n<p>Modularization reduces regulatory complexity and \u2013 together with agile development models \u2013&nbsp;speeds up the time to market,\u202fwhile providing the flexibility we need to&nbsp;continuously adapt functions. Most critically, it reduces risk. The \u201chidden flaw\u201d we talked about earlier \u2013 in a modular system there\u2019s no place to hide, and agile development&nbsp;makes it possible to and correct flaws early in the development cycles.\u200b<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Reducing risk and regulatory complexity\u200b<\/h3>\n\n\n\n<p>We believe that risk is best managed when technical and regulatory responsibility go&nbsp;hand-in-hand. The closer a development team is to the consequences of success or failure&nbsp;\u2013 the more skin they have in the game \u2013 the more we count on them to scrupulously&nbsp;manage risk.&nbsp;We\u2019d&nbsp;been working in the&nbsp;SaMD&nbsp;field from the start, at the intersection of&nbsp;software, life sciences and regulatory, so taking regulatory responsibility for our work was a natural step. How to manage regulatory compliance is an important question for&nbsp;every innovator \u2013 a far-reaching question with many dimensions. For us, most crucial is the link between technical and regulatory responsibility.\u200b<br>\u200bYou can find more about <a href=\"https:\/\/www.capgemini.com\/solutions\/intelligent-products-systems-engineering-for-medtech\/\" target=\"_blank\" rel=\"noreferrer noopener\">our offer<\/a> and <a href=\"https:\/\/www.capgemini.com\/solutions\/capgemini-as-your-legal-manufacturer-for-samd\/\">our Legal Manufacturer capabilities<\/a> on our webpage, and&nbsp;we\u2019re&nbsp;also available to consult on any aspect of risk and compliance.<\/p>\n\n\n\n<p>When your innovations hit the market, dozens of factors affect their success. Avoidable mistakes&nbsp;should not&nbsp;be one of them.&nbsp;Let\u2019s&nbsp;make your products flawless.&nbsp;&nbsp;<\/p>\n\n\n\n<p><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/section>\n\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\"><h3 data-maxlength=\"34\">Meet our experts<\/h3><\/div><\/div><div class=\"slider slider-boxed\"><div class=\"container\"><div class=\"slider-window\"><div class=\"slider-list\">\n\t\t<div class=\"slide\">\n\t\t\t<div class=\"box\">\n\t\t\t\t<div class=\"row\">\n\t\t\t\t\t<div class=\"col-md-6 col-lg-4 box-img-wrapper\">\n\t\t\t\t\t\t<img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2022\/01\/Andrew-Koubatis-2.jpg\" alt=\"Andrew Koubatis\"\/>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div class=\"col-md-6 col-lg-8 box-inner\">\n\t\t\t\t\t\t<div class=\"row title-social-media-header\">\n\t\t\t\t\t\t\t<div class=\"col-md-12 col-lg-6 mbl-social-icon\">\n\t\t\t\t\t\t\t\t<ul class=\"social-nav\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><a aria-label=\"Linkedin\" target=\"_blank\" href=\"https:\/\/www.linkedin.com\/in\/andrew-koubatis-99457a164\/\"><i aria-hidden=\"true\" class=\"icon-li\"><\/i><\/a><\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"col-md-12 col-lg-6 box-container\">\n\t\t\t\t\t\t\t\t<div class=\"box-title\">\n\t\t\t\t\t\t\t\t\t<h3 class=\"people-profile-title\">Andrew Koubatis<\/h3>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span>ER&amp;D Pre-Sales Director<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"col-md-12 col-lg-6 social-box-container dkt-social-icon\">\n\t\t\t\t\t\t\t\t<ul class=\"social-nav\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><a aria-label=\"Linkedin\" target=\"_blank\" href=\"https:\/\/www.linkedin.com\/in\/andrew-koubatis-99457a164\/\"><i aria-hidden=\"true\" class=\"icon-li\"><\/i><\/a><\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\n<\/div><\/div><\/div><div class=\"slider-nav\"><button class=\"slider-prev inactive\" aria-label=\"Anterior\" tabindex=\"-1\"><\/button><ul class=\"slider-paginator\"><\/ul><button class=\"slider-next\" aria-label=\"Siguiente\"><\/button><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"<p>\u200b<\/p>\n","protected":false},"author":282,"featured_media":524579,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"cg_dt_proposed_to":[],"cg_seo_hreflang_relations":"[]","cg_seo_canonical_relation":"","cg_seo_hreflang_x_default_relation":"{\"uuid\":\"9c9ffef2-4f91-484d-b463-cc97f99e8bd2\",\"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":true,"cg_dt_link_disabled":false,"_yoast_wpseo_primary_brand":"81","_jetpack_memberships_contains_paid_content":false,"footnotes":"","featured_focal_points":"{\"x\":0.32,\"y\":0.54}"},"categories":[1],"tags":[397],"brand":[81],"service":[],"industry":[119],"partners":[],"blog-topic":[159],"content-group":[],"class_list":["post-524578","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-life-sciences","brand-capgemini-engineering","industry-life-sciences","blog-topic-technology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.8 (Yoast SEO v22.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b - ÎÚÑ»´«Ã½ Mexico<\/title>\n<meta name=\"description\" content=\"\u200b How a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200bÎÚÑ»´«Ã½27 Jul 2023 FacebookLinkedinIn the field of healthcare As a legal manufacturer, we specialize in safety and compliance for Software as a Medical Device (SaMD). It\u2019s a fast-growing field, with risks hiding in every nook and cranny. How do we make sure we catch and neutralize every risk? How do we ensure safety and compliance, without sacrificing speed? Let\u2019s dive in. \u200b\u200b\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b\" \/>\n<meta property=\"og:description\" content=\"\u200b How a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200bÎÚÑ»´«Ã½27 Jul 2023 FacebookLinkedinIn the field of healthcare As a legal manufacturer, we specialize in safety and compliance for Software as a Medical Device (SaMD). It\u2019s a fast-growing field, with risks hiding in every nook and cranny. How do we make sure we catch and neutralize every risk? How do we ensure safety and compliance, without sacrificing speed? Let\u2019s dive in. \u200b\u200b\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/\" \/>\n<meta property=\"og:site_name\" content=\"ÎÚÑ»´«Ã½ Mexico\" \/>\n<meta property=\"article:published_time\" content=\"2024-07-03T10:35:09+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-03T17:31:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2025\/10\/New-Web-preview-global.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"627\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/\"},\"author\":{\"name\":\"\",\"@id\":\"\"},\"headline\":\"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b\",\"datePublished\":\"2024-07-03T10:35:09+00:00\",\"dateModified\":\"2025-04-03T17:31:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/\"},\"wordCount\":808,\"publisher\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg\",\"keywords\":[\"life sciences\"],\"inLanguage\":\"es-MX\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/\",\"url\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/\",\"name\":\"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b - ÎÚÑ»´«Ã½ Mexico\",\"isPartOf\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg\",\"datePublished\":\"2024-07-03T10:35:09+00:00\",\"dateModified\":\"2025-04-03T17:31:43+00:00\",\"description\":\"\u200b How a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200bÎÚÑ»´«Ã½27 Jul 2023 FacebookLinkedinIn the field of healthcare As a legal manufacturer, we specialize in safety and compliance for Software as a Medical Device (SaMD). It\u2019s a fast-growing field, with risks hiding in every nook and cranny. How do we make sure we catch and neutralize every risk? How do we ensure safety and compliance, without sacrificing speed? Let\u2019s dive in. \u200b\u200b\",\"breadcrumb\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#breadcrumb\"},\"inLanguage\":\"es-MX\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es-MX\",\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#primaryimage\",\"url\":\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg\",\"contentUrl\":\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg\",\"width\":2880,\"height\":1800},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.capgemini.com\/mx-es\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/#website\",\"url\":\"https:\/\/www.capgemini.com\/mx-es\/\",\"name\":\"ÎÚÑ»´«Ã½ Mexico\",\"description\":\"ÎÚÑ»´«Ã½\",\"publisher\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.capgemini.com\/mx-es\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"es-MX\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/#organization\",\"name\":\"ÎÚÑ»´«Ã½ Mexico\",\"url\":\"https:\/\/www.capgemini.com\/mx-es\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es-MX\",\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2025\/07\/linkedin_mwo0q6.png\",\"contentUrl\":\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2025\/07\/linkedin_mwo0q6.png\",\"width\":800,\"height\":800,\"caption\":\"ÎÚÑ»´«Ã½ Mexico\"},\"image\":{\"@id\":\"https:\/\/www.capgemini.com\/mx-es\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"\",\"url\":\"https:\/\/www.capgemini.com\/mx-es\/author\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b - ÎÚÑ»´«Ã½ Mexico","description":"\u200b How a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200bÎÚÑ»´«Ã½27 Jul 2023 FacebookLinkedinIn the field of healthcare As a legal manufacturer, we specialize in safety and compliance for Software as a Medical Device (SaMD). It\u2019s a fast-growing field, with risks hiding in every nook and cranny. How do we make sure we catch and neutralize every risk? How do we ensure safety and compliance, without sacrificing speed? Let\u2019s dive in. \u200b\u200b","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/","og_locale":"es_MX","og_type":"article","og_title":"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b","og_description":"\u200b How a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200bÎÚÑ»´«Ã½27 Jul 2023 FacebookLinkedinIn the field of healthcare As a legal manufacturer, we specialize in safety and compliance for Software as a Medical Device (SaMD). It\u2019s a fast-growing field, with risks hiding in every nook and cranny. How do we make sure we catch and neutralize every risk? How do we ensure safety and compliance, without sacrificing speed? Let\u2019s dive in. \u200b\u200b","og_url":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/","og_site_name":"ÎÚÑ»´«Ã½ Mexico","article_published_time":"2024-07-03T10:35:09+00:00","article_modified_time":"2025-04-03T17:31:43+00:00","og_image":[{"width":1200,"height":627,"url":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2025\/10\/New-Web-preview-global.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_misc":{"Written by":"","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#article","isPartOf":{"@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/"},"author":{"name":"","@id":""},"headline":"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b","datePublished":"2024-07-03T10:35:09+00:00","dateModified":"2025-04-03T17:31:43+00:00","mainEntityOfPage":{"@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/"},"wordCount":808,"publisher":{"@id":"https:\/\/www.capgemini.com\/mx-es\/#organization"},"image":{"@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#primaryimage"},"thumbnailUrl":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg","keywords":["life sciences"],"inLanguage":"es-MX"},{"@type":"WebPage","@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/","url":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/","name":"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b - ÎÚÑ»´«Ã½ Mexico","isPartOf":{"@id":"https:\/\/www.capgemini.com\/mx-es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#primaryimage"},"image":{"@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#primaryimage"},"thumbnailUrl":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg","datePublished":"2024-07-03T10:35:09+00:00","dateModified":"2025-04-03T17:31:43+00:00","description":"\u200b How a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200bÎÚÑ»´«Ã½27 Jul 2023 FacebookLinkedinIn the field of healthcare As a legal manufacturer, we specialize in safety and compliance for Software as a Medical Device (SaMD). It\u2019s a fast-growing field, with risks hiding in every nook and cranny. How do we make sure we catch and neutralize every risk? How do we ensure safety and compliance, without sacrificing speed? Let\u2019s dive in. \u200b\u200b","breadcrumb":{"@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#breadcrumb"},"inLanguage":"es-MX","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/"]}]},{"@type":"ImageObject","inLanguage":"es-MX","@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#primaryimage","url":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg","contentUrl":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg","width":2880,"height":1800},{"@type":"BreadcrumbList","@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.capgemini.com\/mx-es\/"},{"@type":"ListItem","position":2,"name":"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b"}]},{"@type":"WebSite","@id":"https:\/\/www.capgemini.com\/mx-es\/#website","url":"https:\/\/www.capgemini.com\/mx-es\/","name":"ÎÚÑ»´«Ã½ Mexico","description":"ÎÚÑ»´«Ã½","publisher":{"@id":"https:\/\/www.capgemini.com\/mx-es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.capgemini.com\/mx-es\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"es-MX"},{"@type":"Organization","@id":"https:\/\/www.capgemini.com\/mx-es\/#organization","name":"ÎÚÑ»´«Ã½ Mexico","url":"https:\/\/www.capgemini.com\/mx-es\/","logo":{"@type":"ImageObject","inLanguage":"es-MX","@id":"https:\/\/www.capgemini.com\/mx-es\/#\/schema\/logo\/image\/","url":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2025\/07\/linkedin_mwo0q6.png","contentUrl":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2025\/07\/linkedin_mwo0q6.png","width":800,"height":800,"caption":"ÎÚÑ»´«Ã½ Mexico"},"image":{"@id":"https:\/\/www.capgemini.com\/mx-es\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"","url":"https:\/\/www.capgemini.com\/mx-es\/author\/"}]}},"blog_topic_info":[{"id":159,"name":"Technology"}],"taxonomy_info":{"category":[{"id":1,"name":"Uncategorized","slug":"uncategorized"}],"post_tag":[{"id":397,"name":"life sciences","slug":"life-sciences"}],"brand":[{"id":81,"name":"ÎÚÑ»´«Ã½ Engineering","slug":"capgemini-engineering"}],"industry":[{"id":119,"name":"Life sciences","slug":"life-sciences"}],"blog-topic":[{"id":159,"name":"Technology","slug":"technology"}],"following_users":[{"id":141,"name":"automator","slug":"automator"}]},"parsely":{"version":"1.1.0","canonical_url":"https:\/\/capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/","smart_links":{"inbound":0,"outbound":0},"traffic_boost_suggestions_count":0,"meta":{"@context":"https:\/\/schema.org","@type":"NewsArticle","headline":"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b","url":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/","mainEntityOfPage":{"@type":"WebPage","@id":"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/"},"thumbnailUrl":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg?w=150&h=150&crop=1","image":{"@type":"ImageObject","url":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg"},"articleSection":"Uncategorized","author":[],"creator":[],"publisher":{"@type":"Organization","name":"ÎÚÑ»´«Ã½ Mexico","logo":""},"keywords":["life sciences"],"dateCreated":"2024-07-03T10:35:09Z","datePublished":"2024-07-03T10:35:09Z","dateModified":"2025-04-03T17:31:43Z"},"rendered":"<meta name=\"parsely-title\" content=\"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SAMD\u00a0go-to-market\u200b\" \/>\n<meta name=\"parsely-link\" content=\"https:\/\/www.capgemini.com\/mx-es\/insights\/expert-perspectives\/940858-2\/\" \/>\n<meta name=\"parsely-type\" content=\"post\" \/>\n<meta name=\"parsely-image-url\" content=\"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg?w=150&amp;h=150&amp;crop=1\" \/>\n<meta name=\"parsely-pub-date\" content=\"2024-07-03T10:35:09Z\" \/>\n<meta name=\"parsely-section\" content=\"Uncategorized\" \/>\n<meta name=\"parsely-tags\" content=\"life sciences\" \/>","tracker_url":"https:\/\/cdn.parsely.com\/keys\/capgemini.com\/p.js"},"jetpack_featured_media_url":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg","featured_image_src":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg","featured_image_alt":"","jetpack_sharing_enabled":true,"distributor_meta":false,"distributor_terms":false,"distributor_media":false,"distributor_original_site_name":"ÎÚÑ»´«Ã½ Mexico","distributor_original_site_url":"https:\/\/www.capgemini.com\/mx-es","push-errors":false,"featured_image_url":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2024\/07\/How-a-system-based-modular-approach-minimizes-risk-and-accelerates-SaMD-go-to-market\u200b-blog-banner.jpg","author_title":"ÎÚÑ»´«Ã½","author_thumbnail_url":"https:\/\/www.capgemini.com\/mx-es\/wp-content\/uploads\/sites\/28\/2021\/08\/cg-logo-3.png?w=330","author_thumbnail_alt":"","_links":{"self":[{"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/posts\/524578","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/users\/282"}],"replies":[{"embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/comments?post=524578"}],"version-history":[{"count":4,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/posts\/524578\/revisions"}],"predecessor-version":[{"id":539551,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/posts\/524578\/revisions\/539551"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/media\/524579"}],"wp:attachment":[{"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/media?parent=524578"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/categories?post=524578"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/tags?post=524578"},{"taxonomy":"brand","embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/brand?post=524578"},{"taxonomy":"service","embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/service?post=524578"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/industry?post=524578"},{"taxonomy":"partners","embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/partners?post=524578"},{"taxonomy":"blog-topic","embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/blog-topic?post=524578"},{"taxonomy":"content-group","embeddable":true,"href":"https:\/\/www.capgemini.com\/mx-es\/wp-json\/wp\/v2\/content-group?post=524578"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}