{"id":114737,"date":"2024-02-23T09:29:15","date_gmt":"2024-02-23T09:29:15","guid":{"rendered":"https:\/\/www.gcx.com\/%e8%b4%a8%e9%87%8f%e4%b8%8e%e4%bc%99%e4%bc%b4%e5%85%b3%e7%b3%bb\/"},"modified":"2024-04-25T11:57:36","modified_gmt":"2024-04-25T11:57:36","slug":"%e8%b4%a8%e9%87%8f%e4%b8%8e%e4%bc%99%e4%bc%b4%e5%85%b3%e7%b3%bb","status":"publish","type":"page","link":"https:\/\/www.gcx.com\/zh-hant\/oem-%e6%9c%8d%e5%8a%a1\/%e6%96%b9%e6%b3%95\/%e8%b4%a8%e9%87%8f%e4%b8%8e%e4%bc%99%e4%bc%b4%e5%85%b3%e7%b3%bb\/","title":{"rendered":"\u8d28\u91cf\u4e0e\u4f19\u4f34\u5173\u7cfb"},"content":{"rendered":"\n
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\u8d28\u91cf<\/h2>\n

\u4e0b\u9762\u5217\u51fa\u7684\u8ba4\u8bc1\u8bc1\u660e\u4e86\u6211\u4eec\u8ffd\u6c42\u5353\u8d8a\u7684\u627f\u8bfa\uff1a<\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n<\/section>\n\n

\n
\n
\n
\n \"Iso\"\n \n <\/div>\n
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ISO 13485\uff1a<\/strong>GCX \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5df2\u901a\u8fc7 ISO 13485:2016 \u8ba4\u8bc1\u3002 ISO 13485 \u662f\u754c\u5b9a\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u8d28\u91cf\u4f53\u7cfb\u8981\u6c42\u7684\u56fd\u9645\u6807\u51c6\u3002 \u6211\u4eec\u7684 ISO 13485 \u8ba4\u8bc1\u8fd8\u5305\u62ec\u7b26\u5408 ISO 14971 \u8981\u6c42\u7684\u98ce\u9669\u7ba1\u7406\u6d41\u7a0b\u3002 \u67e5\u770b\u8bc1\u4e66<\/a><\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n<\/section>\n\n

\n
\n
\n
\n \"\"\n \n <\/div>\n
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CE \u6807\u5fd7\uff1a<\/strong>\u5927\u591a\u6570 GCX \u4ea7\u54c1\u90fd\u6709 CE \u6807\u5fd7\uff0c\u7b26\u5408\u673a\u68b0\u6307\u4ee4 2006\/42\/EC\u3002 \u6b63\u5982\u6211\u4eec\u81ea\u6211\u58f0\u660e\u7684\u90a3\u6837\uff0cGCX \u6709\u8d23\u4efb\u786e\u5b9a\u54ea\u4e9b\u6807\u51c6\u9002\u7528\u4e8e\u6211\u4eec\u7684\u4ea7\u54c1\u3002 IEC 60601-1 \u662f\u5305\u542b\u533b\u7597\u8bbe\u5907\u5b89\u5168\u8981\u6c42\u7684\u4e66\u9762\u6807\u51c6\uff0c\u5176\u4e2d\u673a\u68b0\u90e8\u5206\u7684\u4e00\u4e9b\u8981\u6c42\u53ef\u9002\u7528\u4e8e GCX \u4ea7\u54c1\u3002 \u8fd9\u662f\u6211\u4eec\u6240\u6709\u5ba2\u6237\u90fd\u77e5\u9053\u5e76\u8bd5\u56fe\u9075\u5b88\u7684\u6807\u51c6\u3002 GCX \u9ed8\u8ba4\u5bf9\u5176\u8fdb\u884c\u6d4b\u8bd5\u3002 \u67e5\u770b\u8bc1\u4e66<\/a><\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n<\/section>\n\n

\n
\n
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\n \"Fda\"\n \n <\/div>\n
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FDA \u6ce8\u518c\u5236\u9020\u5546\uff1a <\/strong>GCX \u662f\u4e00\u5bb6\u6ce8\u518c\u7684\u5408\u540c\u5236\u9020\u5546\u548c I \u7c7b\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u3002<\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n<\/section>\n\n

\n
\n
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\n \"Reachrohs\"\n \n <\/div>\n
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\u7b26\u5408 RoHS \u548c REACH \u6cd5\u89c4\uff1a<\/strong>GCX \u4ea7\u54c1\u7b26\u5408 REACH \u6cd5\u89c4 1907\/2006 \u548c RoHS \u6307\u4ee4 2011\/65\/EU\uff08\u7ecf\u6b27\u76df\u6307\u4ee4 EU\/2015\/863 \u4fee\u8ba2\uff09\u3002 \u8fd9\u4e00\u70b9\u5728\u6211\u4eec\u7684\u6807\u51c6\u5408\u683c\u8bc1\u4e66\u4e0a\u6709\u6240\u8bf4\u660e\uff0c\u8be5\u8bc1\u4e66\u968f\u6bcf\u6279\u8d27\u7269\u4e00\u8d77\u63d0\u4f9b\u3002<\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n<\/section>\n\n

\n
\n
\n
\n \"\"\n \n <\/div>\n
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\u7b26\u5408 IEC 60601-1 \u6807\u51c6\uff1a<\/strong>IEC 60601 \u662f\u4e00\u7cfb\u5217\u5173\u4e8e\u533b\u7597\u7535\u6c14\u8bbe\u5907\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\u7684\u6280\u672f\u6807\u51c6\u3002 \u4f5c\u4e3a\u673a\u68b0\u4ea7\u54c1\u7684\u8bbe\u8ba1\u8005\u548c\u5236\u9020\u5546\uff0cGCX \u9075\u5b88\u6709\u5173\u673a\u68b0\u5b89\u5168\u7684\u9002\u7528\u6761\u6b3e\u3002 \u6240\u6709\u5176\u4ed6\u90e8\u5206\u5747\u4e0d\u9002\u7528\u3002 GCX \u6267\u884c\u5185\u90e8\u6d4b\u8bd5\u4ee5\u9a8c\u8bc1\u5408\u89c4\u6027\u3002<\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n<\/section>\n\n

\n
\n
\n
\n \"EUMDR\"\n \n <\/div>\n
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\u6b27\u76df-MDR\uff1a<\/strong>\u867d\u7136 GCX \u4ea7\u54c1\u4e0d\u5c5e\u4e8e\u6b27\u76df-MDR \u7684\u8303\u56f4\uff0c\u4f46\u6211\u4eec\u7684\u8d28\u91cf\u548c\u5f00\u53d1\u56e2\u961f\u5b9a\u671f\u4e3a\u5ba2\u6237\u63d0\u4f9b\u8d28\u91cf\u548c\u6cd5\u89c4\u652f\u6301\u548c\u6307\u5bfc\uff0c\u4ee5\u786e\u4fdd\u7b26\u5408\u6b27\u76df-MDR \u7b49\u5168\u7403\u6807\u51c6\u548c\u8981\u6c42\u3002<\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n<\/section>\n\n

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\n <\/div>\n <\/div>\n <\/div>\n
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\n \"Oem\n <\/div>\n

150,000<\/h1>\n

\u5df2\u53d1\u8fd0\u7684\u79fb\u52a8\u8f66<\/p>\n <\/div>\n <\/div>\n

\n
\n
\n \"Oem\n <\/div>\n

99.4%<\/h1>\n

\u51c6\u65f6\u53d1\u8d27<\/p>\n <\/div>\n <\/div>\n

\n
\n
\n \"Oem\n <\/div>\n

99.8%<\/h1>\n

\u65e0\u7f3a\u9677\u90e8\u4ef6<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div> <\/section>\n\n

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\u6211\u4eec\u4e0e\u5168\u7403 400 \u591a\u5bb6\u533b\u7597\u8bbe\u5907\u5236\u9020\u5546\u5408\u4f5c\u3002<\/h2>\n

Abbott – Acist – Air Liquide – BD – Boston Scientific – Cadwell – Capsule – Dr\u00e4ger – EchoNous – Edwards – Fresenius Medical Care – FujiFilm – Fukuda Denshi – GE Healthcare – Getinge – Hillrom – Johnson & Johnson – Masimo – Medtronic – Mindray – Natus – Nihon Kohden – Nuvasive – Obix – Olympus – Philips – Smith + Nephew – Spacelabs Healthcare – Stryker – Vapotherm – Varian – Verathon – Zimmer Biomet – Zoll \u7b49\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n<\/section>\n\n

\n
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\n \"Quality\n \n <\/div>\n
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\u53cd\u5e94\u8fc5\u901f\u3001\u53ef\u9760\u3001\u503c\u5f97\u4fe1\u8d56\u7684\u5408\u4f5c\u4f19\u4f34<\/h3>\n
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  • \u6807\u51c6\u4ea7\u54c1\u548c\u5b9a\u5236\u914d\u7f6e\u4ea7\u54c1\u5747\u6309\u7167 IEC \u6807\u51c6\u8fdb\u884c\u4e86\u5168\u9762\u6d4b\u8bd5\uff0c\u5e76\u901a\u8fc7\u4e86\u4e16\u754c\u9876\u7ea7\u533b\u7597\u8bbe\u5907\u5236\u9020\u5546\u7684\u9a8c\u8bc1\u3002<\/li>\n
  • GCX \u5b9a\u671f\u63a5\u53d7\u76d1\u7ba1\u673a\u6784 TUV \u548c OEM \u5ba2\u6237\u7684 ISO 13485 \u5408\u89c4\u6027\u5ba1\u6838\u3002 \u8fd9\u4e9b\u5ba1\u6838\u5458\u4e0d\u65ad\u6ce8\u610f\u5230\uff0c\u6211\u4eec\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4e2d\u8574\u542b\u7740\u5f3a\u70c8\u7684\u5ba2\u6237\u81f3\u4e0a\u548c\u8d28\u91cf\u6587\u5316\u3002<\/li>\n
  • \u6570\u4ee5\u5343\u8ba1\u7684\u533b\u9662\u90fd\u5728\u4f7f\u7528 GCX \u5b89\u88c5\u89e3\u51b3\u65b9\u6848\u3002 \u6211\u4eec\u7684\u7ec4\u4ef6\u548c\u914d\u4ef6\u76ee\u524d\u652f\u6301 400 \u591a\u5bb6\u5236\u9020\u5546\u751f\u4ea7\u7684\u7528\u4e8e\u75c5\u4eba\u76d1\u62a4\u3001\u901a\u6c14\u3001\u5fc3\u7535\u56fe\u3001\u8d85\u58f0\u6ce2\u3001\u9ebb\u9189\u548c IT \u7684\u8bbe\u5907\u3002<\/li>\n<\/ul>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n<\/section>\n\n
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    \u542f\u52a8\u9879\u76ee<\/h3>\n

    \u8ba9\u6211\u4eec\u643a\u624b\u5408\u4f5c\uff0c\u901a\u8fc7\u6211\u4eec\u7684\u533b\u7597\u5236\u9020\u4e13\u5bb6\u548c\u5b9a\u5236\u914d\u7f6e\u6216\u5168\u65b0\u7684\u5b89\u88c5\u89e3\u51b3\u65b9\u6848\uff0c\u5c06\u60a8\u7684\u4e0b\u4e00\u4e2a\u533b\u7597\u5668\u68b0\u6216\u4fdd\u5065\u8bbe\u5907\u5feb\u901f\u63a8\u5411\u5e02\u573a\u3002<\/p>\n <\/div>\n <\/div>\n

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