{"id":739,"date":"2026-05-21T13:53:51","date_gmt":"2026-05-21T13:53:51","guid":{"rendered":"https:\/\/lisconsultgroup.com\/?p=739"},"modified":"2026-07-07T11:44:03","modified_gmt":"2026-07-07T11:44:03","slug":"bringing-an-ai-powered-diagnostic-tool-to-the-european-market","status":"publish","type":"post","link":"https:\/\/lisconsultgroup.com\/index.php\/2026\/05\/21\/bringing-an-ai-powered-diagnostic-tool-to-the-european-market\/","title":{"rendered":"Bringing an AI-powered MD to the European market"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">A MedTech startup developing an AI-based lung nodule detection software engaged LIS Consulting to secure CE marking in Europe. <strong>Challenge:<\/strong>\u00a0Determining the correct regulatory pathway under MDR, classifying the software as a\u00a0<strong>Class IIb SaMD<\/strong>, generating sufficient clinical evidence, and addressing AI-specific requirements such as explainability and future algorithm updates. <strong>Our Approach:<\/strong>\u00a0LIS Consulting developed the regulatory strategy, prepared the SaMD classification rationale, structured the clinical evaluation, and established a process for managing future AI modifications. <strong>Outcome:<\/strong>\u00a0The software achieved\u00a0<strong>CE marking under MDR 2017\/745 (Class IIb)<\/strong>\u00a0within 18 months, supported by a robust technical file, Clinical Evaluation Report, and Post-Market Clinical Follow-Up plan. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A MedTech startup developing an AI-based lung nodule detection software engaged LIS Consulting to secure CE marking in Europe. Challenge:\u00a0Determining the correct regulatory pathway under MDR, classifying the software as a\u00a0Class IIb SaMD, generating sufficient clinical evidence, and addressing AI-specific requirements such as explainability and future algorithm updates. Our Approach:\u00a0LIS Consulting developed the regulatory strategy,&hellip;<\/p>\n<p class=\"more-link\"><a href=\"https:\/\/lisconsultgroup.com\/index.php\/2026\/05\/21\/bringing-an-ai-powered-diagnostic-tool-to-the-european-market\/\" class=\"themebutton2\">Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-739","post","type-post","status-publish","format-standard","hentry","category-lis-consulting"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bringing an AI-powered MD to the European market - LIS CONSULTING<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lisconsultgroup.com\/index.php\/2026\/05\/21\/bringing-an-ai-powered-diagnostic-tool-to-the-european-market\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bringing an AI-powered MD to the European market - LIS CONSULTING\" \/>\n<meta property=\"og:description\" content=\"A MedTech startup developing an AI-based lung nodule detection software engaged LIS Consulting to secure CE marking in Europe. Challenge:\u00a0Determining the correct regulatory pathway under MDR, classifying the software as a\u00a0Class IIb SaMD, generating sufficient clinical evidence, and addressing AI-specific requirements such as explainability and future algorithm updates. 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