{"id":95973,"date":"2023-09-21T20:00:00","date_gmt":"2023-09-21T13:00:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2023092120000095973"},"modified":"2023-09-22T19:05:30","modified_gmt":"2023-09-22T11:05:30","slug":"%e6%95%b0%e9%97%ae%e7%94%9f%e7%89%a9%e5%be%b7%e5%9b%bd%e5%ad%90%e5%85%ac%e5%8f%b8%e9%80%9a%e8%bf%87iso-134852016%e8%ae%a4%e8%af%81","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2023092120000095973","title":{"rendered":"\u6570\u95ee\u751f\u7269\u5fb7\u56fd\u5b50\u516c\u53f8\u901a\u8fc7ISO 13485:2016\u8ba4\u8bc1"},"content":{"rendered":"<p><p><span class=\"legendSpanClass\">\u6e56\u5dde<\/span><span class=\"legendSpanClass\">2023\u5e749\u670821\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; \u8fd1\u65e5\uff0c\u6570\u95ee\u751f\u7269\u7684\u5fb7\u56fd\u5b50\u516c\u53f8Cerca Biotech GmbH\u4ee5\u96f6\u7f3a\u9677\u7684\u6210\u7ee9\u987a\u5229\u901a\u8fc7\u5ba1\u6838\uff0c\u83b7\u5f97ISO 13485:2016\u8ba4\u8bc1\u8bc1\u4e66\u3002<\/p>\n<p>ISO 13485\u662f\u56fd\u9645\u6807\u51c6\u7ec4\u7ec7\uff08International Standards Organization\uff09\u5236\u5b9a\u7684\u5f97\u5230\u56fd\u9645\u516c\u8ba4\u7684\u5173\u4e8e\u4f53\u5916\u8bca\u65ad\u548c\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8981\u6c42\u7684\u6807\u51c6\u89c4\u8303\uff0c\u7814\u53d1\u3001\u751f\u4ea7\u548c\u9500\u552e\u8bf8\u65b9\u9762\u5747\u9075\u5b88\u548c\u7b26\u5408ISO 13485\u6807\u51c6\u662f\u8bca\u65ad\u8bd5\u5242\u548c\u533b\u7597\u5668\u68b0\u5728\u6b27\u76df\u4ee5\u53ca\u4f17\u591a\u5176\u5b83\u56fd\u5bb6\u9500\u552e\u63a8\u5e7f\u7684\u524d\u63d0\u3002<\/p>\n<p>\u6b64\u6b21\u8ba4\u8bc1\u663e\u793a\u6570\u95ee\u751f\u7269\u5df2\u7ecf\u62e5\u6709\u4e86\u4e00\u4e2a\u5b8c\u5584\u7684\u7b26\u5408\u56fd\u9645\u8d28\u91cf\u7ba1\u7406\u6807\u51c6\u7684\u6b27\u6d32\u5b50\u516c\u53f8\uff0c\u4e5f\u6807\u5fd7\u7740\u6570\u95ee\u751f\u7269\u56fd\u9645\u5316\u8fdb\u7a0b\u4e0a\u53c8\u524d\u8fdb\u4e86\u4e00\u6b65\u3002\u76ee\u524d\uff0c\u7531\u6570\u95ee\u751f\u7269\u5728\u4e2d\u56fd\u539f\u7814\u4e16\u754c\u9996\u521b\u7684\u8bca\u65ad\u4ea7\u54c1\u7ecf\u8fc7\u5728\u5fb7\u56fd\u6216\u4e2d\u56fd\u7684\u751f\u4ea7\uff0c\u5df2\u7ecf\u7531\u5176\u5fb7\u56fd\u5b50\u516c\u53f8Cerca Biotech\u7684\u6b27\u6d32\u56e2\u961f\u63a8\u5411\u6b27\u6d32\u548c\u5176\u5b83\u56fd\u9645\u5e02\u573a\uff0c\u5176\u4e2d\u7528\u4e8e\u5bf9\u4e73\u817a\u764c\u8fdb\u884c\u66f4\u5ba2\u89c2\u51c6\u786e\u5730\u5206\u5b50\u5206\u578b\u7684\u5988\u5988\u6cf0\u8c31<sup>&reg;<\/sup>\uff0c\u5df2\u7ecf\u4e0e\u8de8\u56fd\u516c\u53f8\u5e0c\u68ee\u7f8e\u5eb7\u7b49\u516c\u53f8\u5408\u4f5c\u5e7f\u6cdb\u63a8\u5e7f\uff0c\u7528\u4e8e\u5b55\u5987\u5b50\u75eb\u524d\u671f\u5feb\u901f\u7b5b\u67e5\u7684\u5a34\u5bab\u4e3b<sup>&reg;<\/sup>\u7ecf\u8fc7\u725b\u6d25\u5927\u5b66\u7684\u9a8c\u8bc1\u7814\u7a76\u4e5f\u5728\u5e02\u573a\u4e0a\u84c4\u52bf\u5f85\u53d1\u3002\u6b64\u6b21Cerca\u516c\u53f8\u7684ISO 13485:2016\u8ba4\u8bc1\u5c06\u63a8\u52a8\u6570\u95ee\u751f\u7269\u8fdb\u4e00\u6b65\u7684\u56fd\u9645\u5316\u3001\u6210\u4e3a\u5973\u6027\u5065\u5eb7\u8bca\u65ad\u9886\u57df\u7684\u9886\u5bfc\u8005\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u6e56\u5dde2023\u5e749\u670821\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; 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