{"id":4109,"date":"2023-01-31T16:13:16","date_gmt":"2023-01-31T08:13:16","guid":{"rendered":"https:\/\/regask.com\/?p=4109"},"modified":"2024-11-22T05:16:28","modified_gmt":"2024-11-21T21:16:28","slug":"%e8%87%aa%e4%bf%a1%e5%90%88%e8%a7%84%e5%9c%b0%e5%b0%86%e6%82%a8%e7%9a%84-samd-%e6%8e%a8%e5%90%91%e5%b8%82%e5%9c%ba","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/bring-your-samd-to-market-with-confidence-and-compliance\/","title":{"rendered":"\u81ea\u4fe1\u5408\u89c4\u5730\u5c06 SaMD \u63a8\u5411\u5e02\u573a"},"content":{"rendered":"<p>\u6570\u5b57\u5065\u5eb7\u662f\u4e00\u4e2a\u65b0\u5174\u9886\u57df\uff0c\u6b63\u5728\u5f7b\u5e95\u6539\u53d8\u533b\u7597\u4fdd\u5065\u7684\u63d0\u4f9b\u65b9\u5f0f\u3002\u5b83\u7ed3\u5408\u4e86\u6280\u672f\u3001\u6570\u636e\u548c\u5206\u6790\uff0c\u4ee5\u6539\u5584\u8bca\u65ad\u3001\u6cbb\u7597\u548c\u60a3\u8005\u6cbb\u7597\u6548\u679c\u3002\u8f6f\u4ef6\u5373\u533b\u7597\u8bbe\u5907 (SaMD) \u4f5c\u4e3a\u6570\u5b57\u5065\u5eb7\u89e3\u51b3\u65b9\u6848\u7684\u4e00\u4e2a\u5b50\u884c\u4e1a\uff0c\u5728\u884c\u4e1a\u89c4\u6a21\u548c\u521b\u65b0\u65b9\u9762\u90fd\u7ecf\u5386\u4e86\u5feb\u901f\u589e\u957f\u3002<\/p>\n<p>\u968f\u7740\u8d8a\u6765\u8d8a\u591a\u7684 <a href=\"https:\/\/regask.com\/zh\/how-to-regulate-samd-digital-diagnostics-us-eu\/\">\u8428\u9ed8\u5fb7<\/a> \u968f\u7740\u76d1\u7ba1\u7684\u4e0d\u65ad\u63a8\u51fa\uff0c\u8be5\u9886\u57df\u7684\u6cd5\u89c4\u53d8\u5f97\u8d8a\u6765\u8d8a\u590d\u6742\uff0c\u5404\u56fd\u7684\u76d1\u7ba1\u8981\u6c42\u4e5f\u8d8a\u6765\u8d8a\u9ad8\uff0c\u5dee\u5f02\u4e5f\u8d8a\u6765\u8d8a\u5927\u3002\u63a8\u51fa\u4e00\u6b3e\u65b0\u7684 SaMD \u4ea7\u54c1\u53ef\u80fd\u662f\u4e00\u9879\u8270\u5de8\u7684\u4efb\u52a1\u3002\u4e1a\u52a1\u6210\u529f\u7684\u5173\u952e\u5728\u4e8e\u76d1\u7ba1\u5408\u89c4\u6027\u3002\u7136\u800c\uff0c\u6709\u4e86\u6b63\u786e\u7684 <a href=\"https:\/\/regask.com\/zh\/how-to-create-a-winning-regulatory-strategy-for-your-business\/\" target=\"_blank\" rel=\"noopener\">\u76d1\u7ba1\u7b56\u7565<\/a> \u901a\u8fc7\u5b9e\u65bd\uff0c\u516c\u53f8\u53ef\u4ee5\u8c03\u6574\u5176\u4e1a\u52a1\u6218\u7565\u548c\u76d1\u7ba1\u6d3b\u52a8\uff0c\u4ee5\u5b9e\u73b0\u4ea7\u54c1\u5408\u89c4\u548c\u6210\u529f\u8fdb\u5165\u5e02\u573a\u3002<\/p>\n<p>\u56e0\u6b64\uff0cSaMD \u5236\u9020\u5546\u5fc5\u987b\u4e86\u89e3 <a href=\"https:\/\/regask.com\/zh\/when-does-your-app-become-a-medical-device\/\" target=\"_blank\" rel=\"noopener\">\u8f6f\u4ef6\u5982\u4f55\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u53d7\u5230\u76d1\u7ba1<\/a> \u4ee5\u5236\u5b9a\u5f3a\u6709\u529b\u4e14\u6709\u6548\u7684\u76d1\u7ba1\u6218\u7565\u3002<\/p>\n<p>RegASK \u5229\u7528\u6211\u4eec\u5f3a\u5927\u7684\u9886\u57df\u4e13\u4e1a\u77e5\u8bc6\u548c 20 \u591a\u5e74\u7684\u54a8\u8be2\u7ecf\u9a8c\uff0c\u5728\u534f\u52a9 SaMD \u5236\u9020\u5546\u5b9e\u73b0\u76d1\u7ba1\u9014\u5f84\u548c\u5546\u4e1a\u6210\u529f\u65b9\u9762\u6709\u7740\u826f\u597d\u7684\u8bb0\u5f55\u3002<\/p>\n<p><strong>\u4ece\u4ea7\u54c1\u5206\u7c7b\u548c\u6ce8\u518c\u5230\u5546\u4e1a\u5316\uff0c\u9605\u8bfb\u6848\u4f8b\u7814\u7a76\u4e86\u89e3RegASK\u5982\u4f55\u5e2e\u52a9\u4e00\u5bb6\u6570\u5b57\u5065\u5eb7\u516c\u53f8\u5728\u4e9a\u6d32\u5efa\u7acb\u6700\u4f73\u76d1\u7ba1\u7b56\u7565\u3002<\/strong><\/p>\n<h2 class=\"h4\"><strong>\u5ba2\u89c2\u7684<\/strong><\/h2>\n<p>\u4e00\u5bb6\u5168\u7403\u9886\u5148\u7684\u6570\u5b57\u5fc3\u7406\u5065\u5eb7\u62a4\u7406\u63d0\u4f9b\u5546\u5f00\u53d1\u4e86\u4e00\u6b3e\u5e94\u7528\u7a0b\u5e8f\uff0c\u4e3a\u60a3\u6709\u5404\u79cd\u75be\u75c5\u7684\u60a3\u8005\u63d0\u4f9b\u8ba4\u77e5\u884c\u4e3a\u7597\u6cd5 (CBT)\u3002\u5ba2\u6237\u5e0c\u671b\u5728\u9999\u6e2f\u3001\u9a6c\u6765\u897f\u4e9a\u548c\u6cf0\u56fd\u7b49\u51e0\u4e2a\u4e9a\u6d32\u56fd\u5bb6\u63a8\u51fa\u8fd9\u6b3e\u5e94\u7528\u7a0b\u5e8f\u3002<\/p>\n<p>\u5ba2\u6237\u60f3\u77e5\u9053\u4ed6\u4eec\u662f\u5426\u53ef\u4ee5\u5c06\u4ed6\u4eec\u7684\u5e94\u7528\u7a0b\u5e8f\u5546\u4e1a\u5316\uff0c\u4ee5\u53ca\u5728\u76ee\u6807\u5e02\u573a\u4e2d\u662f\u5426\u5b58\u5728\u4efb\u4f55\u9650\u5236\u3002\u4e3a\u4e86\u5b9e\u73b0\u4ed6\u4eec\u7684\u76ee\u6807\uff0c\u5ba2\u6237\u8058\u8bf7 RegASK \u4e3a\u5176 <a href=\"https:\/\/regask.com\/zh\/our-solution\/#monitor\" target=\"_blank\" rel=\"noopener\">\u6cd5\u89c4\u4e8b\u52a1\u54a8\u8be2\u670d\u52a1<\/a>.<\/p>\n<h2 class=\"h4\"><strong>\u89e3\u51b3\u65b9\u6848<\/strong><\/h2>\n<ul>\n<li>\u786e\u5b9a\u4e86\u9999\u6e2f\u3001\u9a6c\u6765\u897f\u4e9a\u548c\u6cf0\u56fd\u9002\u7528\u7684SaMD\u76d1\u7ba1\u6846\u67b6\uff1b<\/li>\n<li>\u786e\u5b9a\u54ea\u4e9b\u56fd\u5bb6\u9700\u8981\u6ce8\u518c\u5ba2\u6237\u7684\u4ea7\u54c1\u4ee5\u53ca\u6ce8\u518c\u6d41\u7a0b\uff1b<\/li>\n<li>\u5206\u6790\u8be5\u4ea7\u54c1\u662f\u5426\u5e94\u6839\u636e\u73b0\u6709\u6cd5\u89c4\u5f52\u7c7b\u4e3a\u533b\u7597\u5668\u68b0\uff1b<\/li>\n<li>\u8bc4\u4f30\u5728\u76ee\u6807\u5e02\u573a\u63a8\u51fa\u5ba2\u6237\u8f6f\u4ef6\u4ee5\u53ca\u5728\u5ba2\u6237\u504f\u597d\u7684\u6a21\u5f0f\u4e0b\u5c06\u5176\u5546\u4e1a\u5316\u7684\u53ef\u80fd\u6027\u3002<\/li>\n<\/ul>\n<h2 class=\"h4\"><strong>\u7ed3\u679c<\/strong><\/h2>\n<p>\u51ed\u501f RegASK \u7684\u4e13\u4e1a\u77e5\u8bc6\uff0c\u5ba2\u6237\u83b7\u5f97\u4e86\u5173\u952e\u4fe1\u606f\uff0c\u4ece\u800c\u786e\u5b9a\u4e86\u5728\u76ee\u6807\u5e02\u573a\u63a8\u51fa\u5176 SaMD \u4ea7\u54c1\u7684\u6700\u5408\u9002\u7684\u76d1\u7ba1\u9014\u5f84\u3002<\/p>\n<p>RegASK \u8fdb\u884c\u7684\u76d1\u7ba1\u6982\u8ff0\u548c\u8bc4\u4f30\u5e2e\u52a9\u5ba2\u6237\u8282\u7701\u4e86\u6570\u767e\u5c0f\u65f6\u7684\u6cd5\u89c4\u641c\u7d22\u65f6\u95f4\uff0c\u5e76\u8bbe\u8ba1\u4e86\u6700\u4f73\u7684\u76d1\u7ba1\u7b56\u7565\uff0c\u4ee5\u6700\u5927\u9650\u5ea6\u5730\u63d0\u9ad8\u6210\u529f\u7684\u673a\u4f1a\u3002<\/p>\n<a data-animate=\"fadeInUp\" href=\"https:\/\/regask.com\/zh\/%e6%a1%88%e4%be%8b%e7%a0%94%e7%a9%b6-2\/%e8%b5%84%e6%ba%90-%e6%a1%88%e4%be%8b%e7%a0%94%e7%a9%b6-%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u66f4\u591a\u6709\u5173\u533b\u7597\u5668\u68b0\u7684\u6848\u4f8b\u7814\u7a76<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>Digital health is an emerging field that is revolutionizing the way healthcare is delivered. It combines technology, data, and analytics to improve diagnoses, treatment, and patient outcomes. Software-as-a-Medical-Device (SaMD), as a subsector of digital health solutions, is experiencing fast growth in both industry scale and innovations. With more and more SaMD being rolled out, regulations&#8230;<\/p>","protected":false},"author":39,"featured_media":4108,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,22,535],"tags":[],"class_list":["post-4109","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-medical-devices","category-thailand-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bringing SaMD to Market with Confidence and Compliance | RegASK<\/title>\n<meta name=\"description\" content=\"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/zh\/\u81ea\u4fe1\u5408\u89c4\u5730\u5c06\u60a8\u7684-samd-\u63a8\u5411\u5e02\u573a\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bringing SaMD to Market with Confidence and Compliance\" \/>\n<meta property=\"og:description\" content=\"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/\u81ea\u4fe1\u5408\u89c4\u5730\u5c06\u60a8\u7684-samd-\u63a8\u5411\u5e02\u573a\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-01-31T08:13:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T21:16:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Bringing SaMD to Market with Confidence and Compliance\",\"datePublished\":\"2023-01-31T08:13:16+00:00\",\"dateModified\":\"2024-11-21T21:16:28+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\"},\"wordCount\":427,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/01\\\/bring-your-samd-to-market-with-confidence-and-compliance.png\",\"articleSection\":[\"Case Studies\",\"Medical Devices\",\"Thailand\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\",\"name\":\"Bringing SaMD to Market with Confidence and Compliance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/01\\\/bring-your-samd-to-market-with-confidence-and-compliance.png\",\"datePublished\":\"2023-01-31T08:13:16+00:00\",\"dateModified\":\"2024-11-21T21:16:28+00:00\",\"description\":\"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.\",\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/01\\\/bring-your-samd-to-market-with-confidence-and-compliance.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/01\\\/bring-your-samd-to-market-with-confidence-and-compliance.png\",\"width\":1600,\"height\":1200,\"caption\":\"Bringing Your Samd To Market With Confidence And Compliance\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u81ea\u4fe1\u5408\u89c4\u5730\u5c06 SaMD \u63a8\u5411\u5e02\u573a | RegASK","description":"\u9605\u8bfb\u6848\u4f8b\u7814\u7a76\uff0c\u4e86\u89e3 RegASK \u5982\u4f55\u534f\u52a9\u4e00\u5bb6\u6570\u5b57\u5065\u5eb7\u516c\u53f8\u5411\u591a\u4e2a\u5e02\u573a\u63a8\u51fa\u5176 SaMD \u4ea7\u54c1\u3002","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:\/\/regask.com\/zh\/\u81ea\u4fe1\u5408\u89c4\u5730\u5c06\u60a8\u7684-samd-\u63a8\u5411\u5e02\u573a\/","og_locale":"zh_CN","og_type":"article","og_title":"Bringing SaMD to Market with Confidence and Compliance","og_description":"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.","og_url":"https:\/\/regask.com\/zh\/\u81ea\u4fe1\u5408\u89c4\u5730\u5c06\u60a8\u7684-samd-\u63a8\u5411\u5e02\u573a\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2023-01-31T08:13:16+00:00","article_modified_time":"2024-11-21T21:16:28+00:00","og_image":[{"width":1600,"height":1200,"url":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"\u4f5c\u8005":"Benoit Trouwaert","\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4":"2 \u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#article","isPartOf":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"Bringing SaMD to Market with Confidence and Compliance","datePublished":"2023-01-31T08:13:16+00:00","dateModified":"2024-11-21T21:16:28+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/"},"wordCount":427,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","articleSection":["Case Studies","Medical Devices","Thailand"],"inLanguage":"zh-Hans"},{"@type":"WebPage","@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/","url":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/","name":"\u81ea\u4fe1\u5408\u89c4\u5730\u5c06 SaMD \u63a8\u5411\u5e02\u573a | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","datePublished":"2023-01-31T08:13:16+00:00","dateModified":"2024-11-21T21:16:28+00:00","description":"\u9605\u8bfb\u6848\u4f8b\u7814\u7a76\uff0c\u4e86\u89e3 RegASK \u5982\u4f55\u534f\u52a9\u4e00\u5bb6\u6570\u5b57\u5065\u5eb7\u516c\u53f8\u5411\u591a\u4e2a\u5e02\u573a\u63a8\u51fa\u5176 SaMD \u4ea7\u54c1\u3002","inLanguage":"zh-Hans","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/"]}]},{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","width":1600,"height":1200,"caption":"Bringing Your Samd To Market With Confidence And Compliance"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"\u52a9\u529b\u66f4\u660e\u667a\u7684\u76d1\u7ba1\u51b3\u7b56","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-Hans"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"\u4f2f\u52aa\u74e6\u00b7\u7279\u9c81\u74e6\u7279"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/4109","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/comments?post=4109"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/4109\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media\/4108"}],"wp:attachment":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media?parent=4109"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/categories?post=4109"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/tags?post=4109"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}