{"id":38157,"date":"2020-05-28T06:30:42","date_gmt":"2020-05-28T13:30:42","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?post_type=press&#038;p=38157"},"modified":"2026-07-23T13:47:11","modified_gmt":"2026-07-23T20:47:11","slug":"jama-software-announces-jama-connect-for-medical-device-development","status":"publish","type":"press","link":"https:\/\/www.jamasoftware.com\/legacy\/company\/press\/jama-software-announces-jama-connect-for-medical-device-development\/","title":{"rendered":"Jama Software Announces Jama Connect\u2122 for Medical Device Development"},"content":{"rendered":"<p><a href=\"https:\/\/www.jamasoftware.com\/?utm_source=google&amp;utm_medium=cpc&amp;utm_campaign=Jama_Software_Brand&amp;_bt=324869374721&amp;_bk=jama%20software&amp;_bm=e&amp;_bn=g&amp;_bg=65016826276&amp;gclid=Cj0KCQiAs67yBRC7ARIsAF49CdXwLt-SiAdfcIUarmH4mpiSWUjgSfbWicPUPr1vVGHK-2NuU1HNQEYaAhksEALw_wcB\">Jama Software<\/a>,\u00a0the leading requirements management solution for building complex products and integrated systems, today introduced\u00a0<a href=\"https:\/\/www.jamasoftware.com\/solutions\/medical-device\/\">Jama Connect\u2122 for Medical Device Development<\/a>,\u00a0a new solution\u00a0designed\u00a0to help engineering teams better manage device requirements, risk and design control all\u00a0on one powerful platform. The newest release makes regulatory submissions and audit preparations a straightforward process, speeding\u00a0time-to-market deployment with no reduction in quality.<\/p>\n<p>Evolving regulations in both the US and Europe, and the need to adhere closely, puts quality and compliance ahead of time-to-market for device manufacturers.\u00a0In this continuously changing\u00a0environment, engineering teams are under pressure to move quickly while simultaneously maintaining product quality and improving management processes along the way.\u00a0<a href=\"http:\/\/www.medpac.gov\/docs\/default-source\/reports\/jun17_ch7.pdf?sfvrsn=0\">Paired that with the fact that costs associated with recalls for a single device can be as much as $600 million<\/a>, demonstrates\u00a0just how vital it is that teams stay aligned.\u00a0Jama Software recognizes these challenges and has been working closely with companies in the\u00a0medical\u00a0device industry to offer an all-in-one solution. Jama Connect for Medical Device Development helps engineering teams get established quickly, allowing them to focus on product design, development, innovation, and helps to reduce the costs and effort involved in preparing for audits.<\/p>\n<p>\u201cDevelopers are balancing increased regulatory requirements with device development costs that lead to challenges across the production lifecycle,\u201d said Josh Turpen, Chief Product Officer at Jama Software. \u201cWe\u2019re excited to introduce\u00a0our new\u00a0solution designed specifically for\u00a0medical\u00a0device\u00a0companies which will help ease the development process from the start. Jama Connect allows developers to hit the ground running with preconfigured templates and best practices built-in, saving product teams from the cumbersome and often frustrating process of filing paperwork.\u201d<\/p>\n<p>Normally, products can undergo multi-month-long review cycles.\u00a0<a href=\"https:\/\/resources.jamasoftware.com\/medical-device\/healthcare-leader-grifols-uses-jama-connect-to-cut-costs-and-speed-development\">However, technology, when properly leveraged, can reduce that review cycle by as much as 75%<\/a>. Jama Connect for Medical Device Development accelerates the development lifecycle with key features including:<\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"Noto Sans Symbols\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">Standard frameworks aligned to industry regulations\u00a0<a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485:2016<\/a>,\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?FR=820.30\">FDA 21 CFR 820.30<\/a>\u00a0and\u00a0<a href=\"https:\/\/www.iso.org\/standard\/72704.html\">ISO 14971:2019<\/a><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Noto Sans Symbols\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\">Export templates for the design history file (DHF) and risk management file<\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Noto Sans Symbols\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\">Best\u00a0practices including procedure and configuration guides to manage design controls, verification and validation, risk management, and adhere to relevant FDA, ISO, IEC and EU regulations<\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Noto Sans Symbols\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\">Ease of onboarding to\u00a0set\u00a0developers\u00a0up quickly with training and documentation aligned to industry regulations, while applying a\u00a0proven\u00a0systems\u00a0engineering approach to\u00a0product\u00a0development<\/li>\n<\/ul>\n<p>\u201cMedical Devices have become increasingly complex and integrated systems. As a result, managing device requirements, conducting risk assessments and ensuring design control with spreadsheets and documents is no longer viable,\u201d said Daniel R.\u00a0Matlis, President of\u00a0Axendia, a leading life-science analyst firm. \u201cMedical Device Manufacturers must leverage integrated platforms that enable them to focus on the introduction of innovative, high-quality products that improve patient outcomes while ensuring compliance to applicable regulatory requirements cost-effectively.\u201d<\/p>\n<p>To learn more about Jama Software\u2019s expertise in communicating, tracking and testing requirements, visit <a href=\"https:\/\/www.jamasoftware.com\/solutions\/medical-device\/\">jamasoftware.com\/solutions\/medical-device\/<\/a>.<\/p>\n<p><strong>Media Contacts\u00a0<\/strong><\/p>\n<p>Karen Gragg<\/p>\n<p>VP, Marketing, Jama Software<\/p>\n<p><a href=\"mailto:marketing@jamasoftware.com\">marketing@jamasoftware.com<\/a><\/p>\n<p><span aria-label=\"Rich text content control\">\ufffc<\/span>(971) 930-1500<\/p>\n<p>&#8212;<\/p>\n<p>Alexandria Plew<\/p>\n<p>Matter Communications<\/p>\n<p><a href=\"mailto:jamasoftware@matternow.com\">jama@matternow.com<\/a><\/p>\n<p>(971) 245-3616<\/p>\n","protected":false},"featured_media":45375,"template":"","class_list":["post-38157","press","type-press","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.1 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Jama Software Announces Jama Connect\u2122 for Medical Device Development - Press Release<\/title>\n<meta name=\"robots\" content=\"noindex, nofollow\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jama Software Announces Jama Connect\u2122 for Medical Device Development\" \/>\n<meta property=\"og:description\" content=\"Jama Software,\u00a0the leading requirements management solution for building complex products and integrated systems, today introduced\u00a0Jama Connect\u2122 for Medical Device Development,\u00a0a new solution\u00a0designed\u00a0to help engineering teams better manage device requirements, risk and design control all\u00a0on one powerful platform. 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