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\u30c1\u30a7\u30fc\u30f3\u3068\u8ca9\u58f2\u30c1\u30a7\u30fc\u30f3\u306e\u4e21\u65b9\u3067\u4e0d\u6b63\u884c\u70ba\u3092\u691c\u51fa\u3057\u3066\u7279\u5b9a\u3059\u308b\u3053\u3068\u307e\u3067\u591a\u5c90\u306b\u308f\u305f\u308a\u307e\u3059\u3002<\/p>\n<p>\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u5206\u6790\u3092\u62e1\u5f35\u3057\u3001\u9867\u5ba2\u30c7\u30fc\u30bf\u3084\u5e02\u5834\u30c7\u30fc\u30bf\u3092\u3001\u51fa\u8377\u6642\u306e\u6e29\u5ea6\u5909\u5316\u306a\u3069\u306e\u696d\u52d9\u3067\u767a\u751f\u3057\u305f\u30a4\u30d9\u30f3\u30c8\u3084\u3001\u6750\u6599\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u5909\u66f4\u306a\u3069\u306e\u88fd\u9020\u30a4\u30d9\u30f3\u30c8\u3001\u88fd\u54c1\u306e\u8a2d\u8a08\u958b\u767a\u306b\u30ea\u30f3\u30af\u3055\u305b\u308b\u3053\u3068\u3067\u3001\u5b89\u5168\u6027\u306e\u5411\u4e0a\u3084\u88fd\u54c1\u63a1\u7528\u306e\u52a0\u901f\u304c\u53ef\u80fd\u306b\u306a\u308a\u3001\u533b\u7642\u88fd\u54c1\u306b\u304a\u3051\u308b\u7d99\u7d9a\u5b66\u7fd2AI\u306e\u5b9f\u73fe\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u3053\u306e\u3088\u3046\u306a\u521d\u671f\u306e\u53d6\u308a\u7d44\u307f\u306f\u3001\u533b\u5b66\u4f1a\u306e\u30ec\u30b8\u30b9\u30c8\u30ea\u306e\u4f7f\u7528\u306b\u3088\u3063\u3066\u5b9f\u8a3c\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001SVS VQI \u30ec\u30b8\u30b9\u30c8\u30ea\u306f\u3001\u30b9\u30c6\u30f3\u30c8\u306e\u4f7f\u7528\u9069\u5fdc\u75c7\u3092\u62e1\u5927\u3059\u308b\u305f\u3081\u306e FDA \u627f\u8a8d\u3092\u52a0\u901f\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3057\u305f\u3002\u6570\u767e\u306e\u75c5\u9662\u304b\u3089\u60a3\u8005\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3059\u308b\u6a5f\u80fd\u306b\u3088\u308a\u3001FDA \u306f\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u6b63\u5e38\u306b\u76e3\u8996\u3067\u304d\u3001\u88fd\u9020\u696d\u8005\u306f\u88fd\u9020\u304b\u3089\u88fd\u54c1\u30c7\u30fc\u30bf\u3092\u53d6\u5f97\u3067\u304d\u307e\u3057\u305f\u3002<\/p>\n<p>\u30c7\u30fc\u30bf \u30bb\u30c3\u30c8\u3092\u62e1\u5f35\u3057\u3066\u88fd\u54c1\u306e TPLC \u304b\u3089\u8907\u96d1\u306a\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3059\u308b\u3053\u3068\u3067\u3001\u88fd\u54c1\u306e\u627f\u8a8d\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u88fd\u9020\u696d\u8005\u304c\u6b21\u4e16\u4ee3\u306e\u88fd\u54c1\u3092\u9769\u65b0\u3059\u308b\u305f\u3081\u306e\u88fd\u54c1\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u628a\u63e1\u3057\u3001\u8ffd\u52a0\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u5fc5\u8981\u3068\u305b\u305a\u306b\u30c7\u30fc\u30bf\u3092\u6d3b\u7528\u3057\u3066\u30e6\u30fc\u30b6\u30fc\u3078\u306e\u9069\u5fdc\u3092\u62e1\u5927\u3057\u3001\u6b21\u4e16\u4ee3\u88fd\u54c1\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306e\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u30a4\u30ce\u30d9\u30fc\u30bf\u30fc\u304c\u8a2d\u8a08\u3068\u88fd\u9020\u304b\u3089\u306e\u30c7\u30fc\u30bf\u3092\u76f8\u4e92\u63a5\u7d9a\u3057\u3001\u73fe\u5b9f\u4e16\u754c\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u6b63\u5e38\u306b\u76e3\u8996\u3067\u304d\u308b\u3053\u3068\u3092\u8a3c\u62e0\u3068\u3068\u3082\u306b\u5b9f\u8a3c\u3059\u308b\u306b\u306f\u3001\u30e2\u30c7\u30eb\u3068\u30a8\u30e9\u30fc\u7387\u306e\u4e21\u65b9\u306e\u691c\u8a3c\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306b\u3001\u9069\u5207\u306a\u30ec\u30d9\u30eb\u306e\u30c7\u30fc\u30bf\u3092\u4f7f\u7528\u3057\u305f\u3001\u3088\u308a\u9ad8\u5ea6\u306a\u7cbe\u67fb\u304c\u5fc5\u8981\u3067\u3059\u3002AI\/ML \u30e2\u30c7\u30eb\u3092\u3088\u308a\u6df1\u304f\u7406\u89e3\u3057\u3001\u3069\u306e\u3088\u3046\u306a\u6761\u4ef6\u4e0b\u3067\u30cb\u30e5\u30fc\u30e9\u30eb \u30cd\u30c3\u30c8\u30ef\u30fc\u30af \u30e2\u30c7\u30eb\u3068\u30d9\u30af\u30bf\u30fc \u30e2\u30c7\u30eb\u3092\u4f7f\u7528\u3059\u308b\u304b\u3001AI\/ML \u30e2\u30c7\u30eb\u3092\u300c\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u300d\u304a\u3088\u3073\u300c\u691c\u8a3c\u300d\u3059\u308b\u305f\u3081\u306b\u3069\u306e\u3088\u3046\u306a\u8a3c\u62e0\u304c\u5fc5\u8981\u304b\u3001\u3055\u3089\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u6761\u4ef6\u4e0b\u3067\u300c\u5b66\u7fd2\u300d\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u3092\u691c\u8a0e\u3067\u304d\u308b\u304b\u3092\u7406\u89e3\u3059\u308b\u5fc5\u8981\u6027\u3082\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<p>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf \u30b7\u30b9\u30c6\u30e0\u691c\u8a3c\u306e\u6b21\u4e16\u4ee3\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u627f\u8a8d\u3055\u308c\u308b\u306b\u3064\u308c\u3066\u3001FDA \u306f\u4f01\u696d\u304c\u88fd\u54c1\u958b\u767a\u3001\u88fd\u9020\u3001\u904b\u7528\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u30c7\u30fc\u30bf\u3092\u751f\u6210\u3001\u53ce\u96c6\u3001\u5206\u6790\u3059\u308b\u6a5f\u80fd\u3092\u3055\u3089\u306b\u958b\u767a\u3057\u3001\u63a1\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002<\/p>\n<p>AI\/ML\u304cTPLC\u306e\u4e00\u90e8\u3092\u52a0\u901f\u3057\u3066\u3044\u308b\u4f8b\u3068\u3057\u3066\u306f\u3001\u30b9\u30bf\u30f3\u30ec\u30fc\u30fb\u30c6\u30c3\u30af\u30b9\u30bf\u30fc\u306a\u3069\u306e\u6295\u8cc7\u5bb6\u306b\u3088\u308b\u88fd\u9020\u696d\u3078\u306e\u6295\u8cc7\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002<sup>2<\/sup>\u6295\u8cc7\u5bb6\u306f\u9769\u65b0\u7684\u306a\u88fd\u9020\u65b9\u6cd5\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002\u5927\u624b\u30e1\u30fc\u30ab\u30fc\u306f\u52b9\u7387\u5316\u306e\u305f\u3081\u306b\u65bd\u8a2d\u9593\u3067\u30c7\u30fc\u30bf\u3092\u9023\u643a\u3055\u305b\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u5c0f\u898f\u6a21\u88fd\u9020\u4f1a\u793e\u3068\u5927\u898f\u6a21\u88fd\u9020\u4f1a\u793e\u306e\u9593\u3067\u3088\u308a\u516c\u5e73\u306a\u7af6\u4e89\u306e\u5834\u304c\u751f\u307e\u308c\u308b\u53ef\u80fd\u6027\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2 class=\"h4\">\u307e\u3068\u3081<\/h2>\n<p>\u3053\u308c\u3089\u306e\u7d4c\u8def\u306e\u3059\u3079\u3066\u306b\u306f\u3001AI \/ ML\u306e\u300c\u30aa\u30f3\u30dc\u30fc\u30c9\u300d\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u7406\u89e3\u304c\u5fc5\u8981\u3067\u3059\u3002\u7279\u5b9a\u306e\u75c5\u72b6\u3084\u75c7\u72b6\u3001\u30a4\u30d9\u30f3\u30c8\u306e\u5927\u91cf\u306e\u4f8b\u3092\u53d6\u5f97\u3057\u3001\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u3092\u6b63\u3057\u304f\u300c\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u300d\u3057\u307e\u3059\u3002<br \/>\n\u5206\u985e\u3057\u307e\u3059\u3002\u73fe\u5728\u3001FDA \u306f\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u3092\u300c\u30ed\u30c3\u30af\u300d\u3059\u308b\u88fd\u54c1\u3001\u3064\u307e\u308a\u7269\u7406\u5b66\u3068\u30eb\u30fc\u30eb\u30d9\u30fc\u30b9\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2 \u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u5f93\u6765\u306e\u65b9\u6cd5\u3092\u627f\u8a8d\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u30c7\u30fc\u30bf\u51e6\u7406\u306e\u504f\u308a\u3092\u6392\u9664\u3057\u3066\u6d1e\u5bdf\u3092\u5f97\u308b AI\/ML \u306e\u5229\u70b9\u306b\u3088\u308a\u3001\u88fd\u54c1\u958b\u767a\u306b\u304a\u3051\u308b\u79d1\u5b66\u7684\u6574\u5408\u6027\u304c\u5411\u4e0a\u3057\u307e\u3059\u3002<\/p>\n<p>\u696d\u754c\u3068 FDA \u306e\u5c06\u6765\u306f\u3001\u7d99\u7d9a\u5b66\u7fd2 AI\/ML \u306b\u3042\u308a\u307e\u3059\u3002\u7d99\u7d9a\u5b66\u7fd2 AI \u306f\u76f4\u63a5\u7684\u306a\u30c7\u30fc\u30bf\u5236\u5fa1\u3068\u8a3c\u660e\u3092\u6392\u9664\u3059\u308b\u305f\u3081\u3001\u30a4\u30ce\u30d9\u30fc\u30bf\u30fc\u306f\u9069\u5207\u306a\u91cf\u306e\u8a3c\u62e0\u3092\u53ce\u96c6\u3059\u308b\u30e1\u30ab\u30cb\u30ba\u30e0\u3068 AI \u958b\u767a\u3092\u8aac\u660e\u3059\u308b\u80fd\u529b\u3092\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u5fc5\u8981\u3068\u3057\u307e\u3059\u3002<\/p>\n<p>\u30a4\u30ce\u30d9\u30fc\u30bf\u30fc\u306b\u306f\u3001AI\/ML \u3084\u65e2\u5b58\u306e FDA \u898f\u5236\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u7d4c\u9a13\u3060\u3051\u3067\u306a\u304f\u3001\u4e21\u65b9\u306e\u5c02\u9580\u5206\u91ce\u3067\u8d77\u3053\u3063\u3066\u3044\u308b\u9032\u5316\u306b\u7a4d\u6975\u7684\u306b\u95a2\u4e0e\u3057\u3066\u3044\u308b SME (Subject Matter Experts) \u3068\u5354\u529b\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002<\/p>\n<div class=\"is-divider divider clearfix\" style=\"max-width:medium;\"><\/div>\n<p>\u53c2\u8003\u6587\u732e:<\/p>\n<p><a href=\"https:\/\/www.techstars.com\/accelerators\/stanley\">https:\/\/www.techstars.com\/accelerators\/stanley<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>COVID has brought a new wave of investments products into healthcare, to springboard innovations leveraging advances in technology, powered by computational biology, artificial intelligence, and mobile platforms. Industries\u2019 investment into advancing healthcare technology is being met with parallel programs across FDA Centers, to support the advancement of innovative technologies. In our recent conversations with FDA, we spoke about their efforts to spearhead advancements on numerous fronts to enable smart pharmaceuticals and devices with an Ironman Jarvis like interface: Between medical products and the body, Modeling the body to accelerate product development, and Modernizing Total Product Lifecycle to monitor and accelerate Next Generation innovations. Realistically \u2013 while synergistic \u2013 these three&#8230;<\/p>","protected":false},"author":39,"featured_media":2205,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[28],"tags":[],"class_list":["post-1094","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Medical Devices Approvals | AI ML TPLC | RegASK<\/title>\n<meta name=\"description\" content=\"How to obtain FDA Medical Devices Approvals for next generation innovations using AI \/ ML to accelerate TPLC within the FDA regulatory framework\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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