{"id":385461,"date":"2025-11-24T13:12:00","date_gmt":"2025-11-24T05:12:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=385461"},"modified":"2025-11-24T13:12:00","modified_gmt":"2025-11-24T05:12:00","slug":"iei-%e9%80%9a%e9%81%8e-tfda-%e9%86%ab%e7%99%82%e5%99%a8%e6%9d%90%e5%93%81%e8%b3%aa%e7%ae%a1%e7%90%86%e7%b3%bb%e7%b5%b1%e6%9f%a5%e9%a9%97%ef%bc%8c%e5%bc%b7%e5%8c%96%e9%86%ab%e7%99%82%e8%a8%ad%e8%a8%88","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=385461","title":{"rendered":"IEI \u901a\u904e TFDA \u91ab\u7642\u5668\u6750\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u67e5\u9a57\uff0c\u5f37\u5316\u91ab\u7642\u8a2d\u8a08\u79fb\u8f49\u8207\u91cf\u7522\u80fd\u529b"},"content":{"rendered":"<div>\n<p><b><i>\u96d9\u91cd\u8cc7\u683c\u52a0\u901f\u5168\u7403\u8a2d\u8a08\u79fb\u8f49\u8207\u6cd5\u898f\u7b26\u5408\u3002<\/i><\/b><\/p>\n<p><span class=\"legendSpanClass\">\u53f0\u5317<\/span><span class=\"legendSpanClass\">2025\u5e7411\u670824\u65e5<\/span> 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href=\"https:\/\/www.ieiworld.com\/medical-solution\/en\/medical-solution.php\" target=\"_blank\" rel=\"nofollow\" style=\"color: #0000FF\">IEI Medical Portal<\/a>\u3002<br \/>\u6df1\u5165\u4e86\u89e3 IEI\uff0c\u8acb\u9020\u8a2a\uff1a<a href=\"http:\/\/www.ieiworld.com\/en\" target=\"_blank\" rel=\"nofollow\" style=\"color: #0000FF\">www.ieiworld.com\/en<\/a><\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder2\">\n<p style=\"TEXT-ALIGN: center; WIDTH: 100%\"> <a href=\"https:\/\/mma.prnasia.com\/media2\/2829418\/IEI_Integration_Corp_announces_TFDA_Quality_Management_System__QMS__approval.html\" target=\"_blank\" rel=\"nofollow\" style=\"color: #0000FF\">  <\/a> <br \/><span>IEI Integration Corp. \u5ba3\u5e03\u53d6\u5f97 TFDA \u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\uff08QMS\uff09\u6838\u53ef\uff0c\u4e26\u6301\u7e8c\u7dad\u6301 ISO 13485:2016 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\u91ab\u7642\u4e8b\u696d\u7fa4\u8cc7\u6df1\u526f\u7e3d\u7d93\u7406 Kenny Jan\u8868\u793a\uff1a\u300c\u5728 ISO 13485 \u4e4b\u4e0a\u518d\u758a\u52a0 TFDA \u6838\u53ef\uff0c\u4ee3\u8868\u66f4\u9806\u66a2\u3001\u53ef\u9810\u671f\u7684\u7a3d\u6838\u3001\u66f4\u5feb\u901f\u7684\u8a2d\u8a08\u79fb\u8f49\uff0c\u4ee5\u53ca\u5728\u53d7\u7ba1\u5236\u5e02\u5834\u4e2d\u66f4\u53ef\u9810\u671f\u7684\u91cf\u7522\u64f4\u5145\u3002\u300d\u4ee5\u4e00\u9805\u9762\u5411\u6b50\u6d32\u5e02\u5834\u7684\u7b2c\u4e8c\u7b49\u7d1a\u5167\u8996\u93e1\u91ab\u6750\u5c08\u6848\u70ba\u4f8b\uff0cIEI \u5c0e\u5165\u9ad8\u5ea6\u81ea\u52d5\u5316\u7684\u667a\u6167\u5de5\u5ee0\u80fd\u529b\u2014\u2014\u542b\u64bf\u6599\u5c0e\u5f15\uff08pick-to-light\uff09\u3001X \u5149\u9ede\u6599\u8207\u81ea\u52d5\u8996\u89ba\u8b58\u5225\u2014\u2014\u4ee5\u7a69\u5b9a\u91cf\u7522\u722c\u5761\uff1b\u4e26\u900f\u904e\u8207 MES \u9023\u7d50\u7684\u8ffd\u6eaf\u6a5f\u5236\u3001AXI\uff0f\u8996\u89ba\u6aa2\u6e2c\u8207 CAPA \u4f50\u8b49\uff0c\u5168\u9762\u652f\u63f4\u7a3d\u6838\u5c31\u7dd2\u3002 IEI \u4f9d\u5faa\u300cTrust Stack \u4fe1\u4efb\u67b6\u69cb\u300d\u6cbb\u7406\u6a21\u578b\u71df\u904b\u7b26\u5408 ISO 13485\uff0fTFDA \u7684\u667a\u6167\u5de5\u5ee0\uff0c\u7bc4\u7587\u6db5\u84cb ISO\/IEC 27001\uff08\u8cc7\u5b89\uff09\u3001ISO 28000\uff08\u4f9b\u61c9\u93c8\u5b89\u5168\uff09\u3001IECQ QC 080000\uff08\u6709\u5bb3\u7269\u8cea\u6d41\u7a0b\u6cbb\u7406\uff09\uff0c\u4ee5\u53ca\u7d44\u7e54\u5c64\u7d1a\u7684 ISO 14064-1 \u6eab\u5ba4\u6c23\u9ad4\u76e4\u67e5\u3002\u6b64\u67b6\u69cb\u53ef\u7e2e\u77ed\u9a57\u8b49\u6642\u7a0b\u3001\u7c21\u5316\u7a3d\u6838\u6d41\u7a0b\uff0c\u4e26\u78ba\u4fdd\u7aef\u5230\u7aef\u900f\u660e\u5ea6\u3002\u85c9\u7531\u7d50\u5408\u570b\u5167 TFDA \u6cd5\u898f\u8207\u570b\u969b ISO \u6846\u67b6\uff0cIEI \u70ba\u91ab\u7642\u54c1\u724c\u5ba2\u6236\u63d0\u4f9b\u900f\u660e\u3001\u53ef\u7a3d\u6838\u4e14\u9762\u5411\u591a\u5e02\u5834\u64f4\u5f35\u7684\u88fd\u9020\u57fa\u790e\u3002 \u95dc\u65bc IEI \u5a01\u5f37\u96fb\u5de5\u696d\u96fb\u8166 IEI \u5a01\u5f37\u96fb\u5275\u7acb\u65bc 1997 \u5e74\uff0c\u662f\u5168\u7403\u91ab\u7642\u8207\u5de5\u696d\u904b\u7b97\u5e73\u53f0\u4ee5\u53ca CDMO\/ODM \u670d\u52d9\u4f9b\u61c9\u5546\u3002IEI \u900f\u904e\u5b8c\u5584\u7684\u8a2d\u8a08\u5230\u88fd\u9020\uff08design-to-manufacturing\uff09\u5c08\u696d\u80fd\u529b\uff0c\u652f\u63f4\u53d7\u6cd5\u898f\u7ba1\u7406\u7684\u91ab\u7642\u79d1\u6280\uff08MedTech\uff09\u8207\u908a\u7de3 AI \u61c9\u7528\uff0c\u4e26\u63d0\u4f9b\u5148\u9032\u7684\u91ab\u7642\u96fb\u8166\u3001\u7db2\u8def\u8a2d\u5099\u8207\u5d4c\u5165\u5f0f\u5e73\u53f0\uff0c\u642d\u914d\u5f37\u5065\u7684\u54c1\u8cea\u3001\u6cd5\u898f\u8207\u8cc7\u5b89\u7ba1\u7406\u67b6\u69cb\uff0c\u5354\u52a9\u5ba2\u6236\u52a0\u901f\u7522\u54c1\u8a2d\u8a08\u3001\u9a57\u8b49\u8207\u91cf\u7522\u5c0e\u5165\u3002 \u66f4\u591a\u91ab\u7642\u79d1\u6280\u8cc7\u8a0a\uff0c\u8acb\u9020\u8a2a IEI Medical Portal\u3002\u6df1\u5165\u4e86\u89e3 IEI\uff0c\u8acb\u9020\u8a2a\uff1awww.ieiworld.com\/en     IEI Integration Corp. \u5ba3\u5e03\u53d6\u5f97 TFDA \u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\uff08QMS\uff09\u6838\u53ef\uff0c\u4e26\u6301\u7e8c\u7dad\u6301 ISO 13485:2016 \u8a8d\u8b49\uff0c\u9032\u4e00\u6b65\u5f37\u5316\u5176\u5728\u91ab\u7642\u5668\u6750\u8a2d\u8a08\u79fb\u8f49\u53ca\u6cd5\u898f\u7ba1\u5236\u91cf\u7522\u4e0a\u7684\u7a3d\u6838\u5c31\u7dd2\u88fd\u9020\u80fd\u529b\u3002\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pingtungtimes.com.tw\/?p=385461\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IEI \u901a\u904e TFDA \u91ab\u7642\u5668\u6750\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u67e5\u9a57\uff0c\u5f37\u5316\u91ab\u7642\u8a2d\u8a08\u79fb\u8f49\u8207\u91cf\u7522\u80fd\u529b - 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OEM\uff0fODM\uff0fCDMO \u5ba2\u6236\u52a0\u901f\u6cd5\u898f\u5c31\u7dd2\u4e26\u5728\u4e9e\u6d32\u3001\u00a0\u7f8e\u570b\u8207\u6b50\u6d32\u64f4\u5927\u91cf\u7522\u3002   &amp;amp;amp;amp;amp;amp;nbsp;\u5728\u9019\u652f\u5f71\u7247\u4e2d\uff0cIEI \u5c55\u793a\u5176\u5b8c\u6574\u7684\u91ab\u7642\u904b\u7b97\u7522\u54c1\u4f48\u5c40\uff0c\u6db5\u84cb \u91ab\u7642\u9762\u677f\u96fb\u8166\uff08Medical Panel PC\uff09\u3001\u91ab\u7642\u7d1a AI Box PC\u3001\u91ab\u7642\u986f\u793a\u5668\uff08Medical Monitor\uff09 \u53ca \u884c\u52d5\u8b77\u7406\u89e3\u6c7a\u65b9\u6848\uff08Mobility Solutions\uff09\u3002\u7d50\u5408 \u908a\u7de3 AI \u904b\u7b97\u3001\u91ab\u7642\u5f71\u50cf\u8207\u667a\u6167\u91ab\u7642\u6574\u5408\u6280\u8853\uff0cIEI \u81f4\u529b\u63d0\u4f9b\u7a69\u5b9a\u3001\u53ef\u64f4\u5c55\u7684\u6b21\u4e16\u4ee3\u667a\u6167\u91ab\u7642\u7cfb\u7d71\u89e3\u6c7a\u65b9\u6848\u3002  \u6191\u85c9 TFDA \u7b2c\u4e8c\u7b49\u7d1a\uff08Class II\uff09\u8cc7\u683c\uff0cIEI \u805a\u7126\u65bc\u91ab\u7642\u5f71\u50cf\u5468\u908a\u3001\u751f\u547d\u5fb5\u8c61\u76e3\u6e2c\u3001\u4ee5\u53ca\u5167\u8996\u93e1\uff0f\u624b\u8853\u5ba4\u6574\u5408\u7b49 CDMO \u5408\u4f5c\u9818\u57df\uff0c\u5c07\u5408\u898f\u8a2d\u8a08\u66f4\u5feb\u901f\u5730\u5c0e\u5165\u81e8\u5e8a\u4f7f\u7528\u3002IEI \u4e03\u5835\uff08Chi-Du\uff09\u5712\u5340\u6bcf\u6708\u53ef\u4f9b\u61c9\u00a038K \u7247 PCBA \u8207\u00a038K \u53f0\u7cfb\u7d71\u6574\u6a5f\uff0c\u652f\u63f4\u5feb\u901f\u722c\u5761\u8207\u5340\u57df\u6027\u914d\u92b7\u3002\u53e6\u898f\u5283\u65bc\u6843\u5712\u589e\u8a2d\u7522\u80fd\uff0c\u5c07\u63a1\u5206\u968e\u6bb5\u5efa\u7f6e\uff0c\u4ee5\u6eff\u8db3\u9700\u6c42\u9810\u6e2c\u4e26\u512a\u5316\u5340\u57df\u5316\u7269\u6d41\u3002 IEI \u91ab\u7642\u4e8b\u696d\u7fa4\u8cc7\u6df1\u526f\u7e3d\u7d93\u7406 Kenny Jan\u8868\u793a\uff1a\u300c\u5728 ISO 13485 \u4e4b\u4e0a\u518d\u758a\u52a0 TFDA \u6838\u53ef\uff0c\u4ee3\u8868\u66f4\u9806\u66a2\u3001\u53ef\u9810\u671f\u7684\u7a3d\u6838\u3001\u66f4\u5feb\u901f\u7684\u8a2d\u8a08\u79fb\u8f49\uff0c\u4ee5\u53ca\u5728\u53d7\u7ba1\u5236\u5e02\u5834\u4e2d\u66f4\u53ef\u9810\u671f\u7684\u91cf\u7522\u64f4\u5145\u3002\u300d\u4ee5\u4e00\u9805\u9762\u5411\u6b50\u6d32\u5e02\u5834\u7684\u7b2c\u4e8c\u7b49\u7d1a\u5167\u8996\u93e1\u91ab\u6750\u5c08\u6848\u70ba\u4f8b\uff0cIEI \u5c0e\u5165\u9ad8\u5ea6\u81ea\u52d5\u5316\u7684\u667a\u6167\u5de5\u5ee0\u80fd\u529b\u2014\u2014\u542b\u64bf\u6599\u5c0e\u5f15\uff08pick-to-light\uff09\u3001X \u5149\u9ede\u6599\u8207\u81ea\u52d5\u8996\u89ba\u8b58\u5225\u2014\u2014\u4ee5\u7a69\u5b9a\u91cf\u7522\u722c\u5761\uff1b\u4e26\u900f\u904e\u8207 MES \u9023\u7d50\u7684\u8ffd\u6eaf\u6a5f\u5236\u3001AXI\uff0f\u8996\u89ba\u6aa2\u6e2c\u8207 CAPA \u4f50\u8b49\uff0c\u5168\u9762\u652f\u63f4\u7a3d\u6838\u5c31\u7dd2\u3002 IEI \u4f9d\u5faa\u300cTrust Stack \u4fe1\u4efb\u67b6\u69cb\u300d\u6cbb\u7406\u6a21\u578b\u71df\u904b\u7b26\u5408 ISO 13485\uff0fTFDA \u7684\u667a\u6167\u5de5\u5ee0\uff0c\u7bc4\u7587\u6db5\u84cb ISO\/IEC 27001\uff08\u8cc7\u5b89\uff09\u3001ISO 28000\uff08\u4f9b\u61c9\u93c8\u5b89\u5168\uff09\u3001IECQ QC 080000\uff08\u6709\u5bb3\u7269\u8cea\u6d41\u7a0b\u6cbb\u7406\uff09\uff0c\u4ee5\u53ca\u7d44\u7e54\u5c64\u7d1a\u7684 ISO 14064-1 \u6eab\u5ba4\u6c23\u9ad4\u76e4\u67e5\u3002\u6b64\u67b6\u69cb\u53ef\u7e2e\u77ed\u9a57\u8b49\u6642\u7a0b\u3001\u7c21\u5316\u7a3d\u6838\u6d41\u7a0b\uff0c\u4e26\u78ba\u4fdd\u7aef\u5230\u7aef\u900f\u660e\u5ea6\u3002\u85c9\u7531\u7d50\u5408\u570b\u5167 TFDA \u6cd5\u898f\u8207\u570b\u969b ISO \u6846\u67b6\uff0cIEI \u70ba\u91ab\u7642\u54c1\u724c\u5ba2\u6236\u63d0\u4f9b\u900f\u660e\u3001\u53ef\u7a3d\u6838\u4e14\u9762\u5411\u591a\u5e02\u5834\u64f4\u5f35\u7684\u88fd\u9020\u57fa\u790e\u3002 \u95dc\u65bc IEI \u5a01\u5f37\u96fb\u5de5\u696d\u96fb\u8166 IEI \u5a01\u5f37\u96fb\u5275\u7acb\u65bc 1997 \u5e74\uff0c\u662f\u5168\u7403\u91ab\u7642\u8207\u5de5\u696d\u904b\u7b97\u5e73\u53f0\u4ee5\u53ca CDMO\/ODM \u670d\u52d9\u4f9b\u61c9\u5546\u3002IEI \u900f\u904e\u5b8c\u5584\u7684\u8a2d\u8a08\u5230\u88fd\u9020\uff08design-to-manufacturing\uff09\u5c08\u696d\u80fd\u529b\uff0c\u652f\u63f4\u53d7\u6cd5\u898f\u7ba1\u7406\u7684\u91ab\u7642\u79d1\u6280\uff08MedTech\uff09\u8207\u908a\u7de3 AI \u61c9\u7528\uff0c\u4e26\u63d0\u4f9b\u5148\u9032\u7684\u91ab\u7642\u96fb\u8166\u3001\u7db2\u8def\u8a2d\u5099\u8207\u5d4c\u5165\u5f0f\u5e73\u53f0\uff0c\u642d\u914d\u5f37\u5065\u7684\u54c1\u8cea\u3001\u6cd5\u898f\u8207\u8cc7\u5b89\u7ba1\u7406\u67b6\u69cb\uff0c\u5354\u52a9\u5ba2\u6236\u52a0\u901f\u7522\u54c1\u8a2d\u8a08\u3001\u9a57\u8b49\u8207\u91cf\u7522\u5c0e\u5165\u3002 \u66f4\u591a\u91ab\u7642\u79d1\u6280\u8cc7\u8a0a\uff0c\u8acb\u9020\u8a2a IEI Medical Portal\u3002\u6df1\u5165\u4e86\u89e3 IEI\uff0c\u8acb\u9020\u8a2a\uff1awww.ieiworld.com\/en     IEI Integration Corp. \u5ba3\u5e03\u53d6\u5f97 TFDA 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\u4fe1\u4efb\u67b6\u69cb\u300d\u6cbb\u7406\u6a21\u578b\u71df\u904b\u7b26\u5408 ISO 13485\uff0fTFDA \u7684\u667a\u6167\u5de5\u5ee0\uff0c\u7bc4\u7587\u6db5\u84cb ISO\/IEC 27001\uff08\u8cc7\u5b89\uff09\u3001ISO 28000\uff08\u4f9b\u61c9\u93c8\u5b89\u5168\uff09\u3001IECQ QC 080000\uff08\u6709\u5bb3\u7269\u8cea\u6d41\u7a0b\u6cbb\u7406\uff09\uff0c\u4ee5\u53ca\u7d44\u7e54\u5c64\u7d1a\u7684 ISO 14064-1 \u6eab\u5ba4\u6c23\u9ad4\u76e4\u67e5\u3002\u6b64\u67b6\u69cb\u53ef\u7e2e\u77ed\u9a57\u8b49\u6642\u7a0b\u3001\u7c21\u5316\u7a3d\u6838\u6d41\u7a0b\uff0c\u4e26\u78ba\u4fdd\u7aef\u5230\u7aef\u900f\u660e\u5ea6\u3002\u85c9\u7531\u7d50\u5408\u570b\u5167 TFDA \u6cd5\u898f\u8207\u570b\u969b ISO \u6846\u67b6\uff0cIEI \u70ba\u91ab\u7642\u54c1\u724c\u5ba2\u6236\u63d0\u4f9b\u900f\u660e\u3001\u53ef\u7a3d\u6838\u4e14\u9762\u5411\u591a\u5e02\u5834\u64f4\u5f35\u7684\u88fd\u9020\u57fa\u790e\u3002 \u95dc\u65bc IEI \u5a01\u5f37\u96fb\u5de5\u696d\u96fb\u8166 IEI \u5a01\u5f37\u96fb\u5275\u7acb\u65bc 1997 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\u91ab\u7642\u9762\u677f\u96fb\u8166\uff08Medical Panel PC\uff09\u3001\u91ab\u7642\u7d1a AI Box PC\u3001\u91ab\u7642\u986f\u793a\u5668\uff08Medical Monitor\uff09 \u53ca \u884c\u52d5\u8b77\u7406\u89e3\u6c7a\u65b9\u6848\uff08Mobility Solutions\uff09\u3002\u7d50\u5408 \u908a\u7de3 AI \u904b\u7b97\u3001\u91ab\u7642\u5f71\u50cf\u8207\u667a\u6167\u91ab\u7642\u6574\u5408\u6280\u8853\uff0cIEI \u81f4\u529b\u63d0\u4f9b\u7a69\u5b9a\u3001\u53ef\u64f4\u5c55\u7684\u6b21\u4e16\u4ee3\u667a\u6167\u91ab\u7642\u7cfb\u7d71\u89e3\u6c7a\u65b9\u6848\u3002 \u6191\u85c9 TFDA \u7b2c\u4e8c\u7b49\u7d1a\uff08Class II\uff09\u8cc7\u683c\uff0cIEI \u805a\u7126\u65bc\u91ab\u7642\u5f71\u50cf\u5468\u908a\u3001\u751f\u547d\u5fb5\u8c61\u76e3\u6e2c\u3001\u4ee5\u53ca\u5167\u8996\u93e1\uff0f\u624b\u8853\u5ba4\u6574\u5408\u7b49 CDMO \u5408\u4f5c\u9818\u57df\uff0c\u5c07\u5408\u898f\u8a2d\u8a08\u66f4\u5feb\u901f\u5730\u5c0e\u5165\u81e8\u5e8a\u4f7f\u7528\u3002IEI 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