{"id":8548,"date":"2024-06-03T16:11:37","date_gmt":"2024-06-03T08:11:37","guid":{"rendered":"https:\/\/www.brosmed.com\/?p=8548"},"modified":"2024-06-03T16:11:40","modified_gmt":"2024-06-03T08:11:40","slug":"%e5%9b%9e%e7%9c%b82023%e4%b8%a8%e5%90%8c%e5%bf%83%e8%81%9a%e5%8a%9b-%e5%8a%bf%e5%9c%a8%e5%bf%85%e8%b5%a2%ef%bc%81%e5%8d%9a%e8%bf%88%e5%8c%bb%e7%96%97%e5%b9%b4%e5%ba%a6%e8%8d%a3%e8%aa%89%e6%80%bb","status":"publish","type":"post","link":"https:\/\/www.brosmed.com\/2024\/06\/%e5%9b%9e%e7%9c%b82023%e4%b8%a8%e5%90%8c%e5%bf%83%e8%81%9a%e5%8a%9b-%e5%8a%bf%e5%9c%a8%e5%bf%85%e8%b5%a2%ef%bc%81%e5%8d%9a%e8%bf%88%e5%8c%bb%e7%96%97%e5%b9%b4%e5%ba%a6%e8%8d%a3%e8%aa%89%e6%80%bb\/","title":{"rendered":"\u56de\u77382023\u4e28\u540c\u5fc3\u805a\u529b \u52bf\u5728\u5fc5\u8d62\uff01\u535a\u8fc8\u533b\u7597\u5e74\u5ea6\u8363\u8a89\u603b\u7ed3"},"content":{"rendered":"\n<p class=\"has-text-align-center\"><strong>2023\u5e74\u5ea6\u8363\u8a89\u603b\u7ed3<\/strong><\/p>\n\n\n\n<p class=\"has-text-align-center\">\u540c\u5fc3\u805a\u529b \u52bf\u5728\u5fc5\u8d62<\/p>\n\n\n\n<p class=\"has-text-align-center\">\u56de\u77382023 \u672a\u77e5\u4e0e\u6311\u6218\u5e76\u5b58<\/p>\n\n\n\n<p class=\"has-text-align-center\">\u8fd9\u4e00\u5e74\uff0c\u535a\u8fc8\u4eba\u6b65\u5c65\u4e0d\u505c\uff0c\u521b\u65b0\u4e0d\u6b62\uff0c<\/p>\n\n\n\n<p class=\"has-text-align-center\">\u56de\u987e\u5f53\u4e0b\u8363\u5149\uff0c\u6210\u7ee9\u6590\u7136\u3002<\/p>\n\n\n\n<p class=\"has-text-align-center\">\u5728\u8fd9\u4e2a\u5145\u6ee1\u53d8\u5316\u548c\u673a\u9047\u7684\u4e00\u5e74\u91cc\uff0c<br>\u6709\u5e78\u80fd\u4e0e\u5927\u5bb6\u5e76\u80a9\u540c\u884c<br>\u63a5\u4e0b\u6765\u8ba9\u6211\u4eec\u4e00\u8d77\u56de\u987e\u8fd9\u4e00\u5e74\u6536\u83b7\u7684\u8363\u8a89<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>\u5e7f\u4e1c\u7701\u540d\u4f18\u9ad8\u65b0\u6280\u672f\u4ea7\u54c1<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" 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has-text-color\">2023\u5e74\u4e09\u6708\uff0c\u535a\u8fc8\u533b\u7597\u6210\u529f\u83b7\u6279<strong>\u7531\u5e7f\u4e1c\u7701\u4eba\u529b\u8d44\u6e90\u548c\u793e\u4f1a\u4fdd\u969c\u5385\u8bc4\u5b9a\u7684\u5e7f\u4e1c\u7701\u535a\u58eb\u5de5\u4f5c\u7ad9\u3002<\/strong>\u8be5\u5de5\u4f5c\u7ad9\u7684\u8bbe\u7acb\u662f\u5e7f\u4e1c\u7701\u4eba\u529b\u8d44\u6e90\u548c\u793e\u4f1a\u4fdd\u969c\u5385\u5bf9\u535a\u8fc8\u533b\u7597\u79d1\u7814\u80fd\u529b\u3001\u7efc\u5408\u7ba1\u7406\u6c34\u5e73\u53ca\u670d\u52a1\u80fd\u529b\u7684\u80af\u5b9a\uff0c\u610f\u5473\u7740\u535a\u8fc8\u533b\u7597\u5c06\u5177\u5907\u5438\u7eb3\u3001\u5f15\u8fdb\u3001\u805a\u96c6\u66f4\u591a\u535a\u58eb\u535a\u58eb\u540e\u4eba\u624d\u7684\u8d44\u683c\u548c\u80fd\u529b\uff0c\u662f\u535a\u8fc8\u533b\u7597\u4eba\u624d\u961f\u4f0d\u5efa\u8bbe\u7684\u4e00\u6b21\u98de\u8dc3\uff0c\u4e5f\u662f\u6784\u5efa\u9ad8\u5c42\u6b21\u4eba\u624d\u961f\u4f0d\u7684\u4e00\u4e2a\u65b0\u7684\u91cc\u7a0b\u7891\u3002<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>MDSAP\u8bc1\u4e66<\/strong><\/p>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" width=\"724\" height=\"1024\" src=\"https:\/\/www.brosmed.com\/wp-content\/uploads\/2024\/01\/\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_17059049943660-1-724x1024.png\" alt=\"\" class=\"wp-image-8559\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" width=\"724\" height=\"1024\" src=\"https:\/\/www.brosmed.com\/wp-content\/uploads\/2024\/01\/\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_1705905011599-1-724x1024.png\" alt=\"\" class=\"wp-image-8560\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" width=\"724\" height=\"1024\" src=\"https:\/\/www.brosmed.com\/wp-content\/uploads\/2024\/01\/\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_17059050171511-1-724x1024.png\" alt=\"\" class=\"wp-image-8561\"\/><\/figure>\n<\/div><\/div>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>2023\u5e74\u535a\u8fc8\u533b\u7597\u987a\u5229\u5b8c\u6210\u8d28\u91cf\u4f53\u7cfb\u201c\u533b\u7597\u5668\u68b0\u5355\u4e00\u5ba1\u6838\u7a0b\u5e8f\u201d\uff08Medical Device Single Audit Program\uff0cMDSAP\uff09\u8ba4\u8bc1\uff0c\u5e76\u83b7\u5f97\u7531\u56fd\u9645\u8ba4\u8bc1\u673a\u6784TUV \u83b1\u8335\u516c\u53f8\u9881\u53d1\u7684MDSAP\u8bc1\u4e66\u3002<\/strong>\u8be5\u8bc1\u4e66\u7684\u83b7\u53d6\u6807\u5fd7\u535a\u8fc8\u533b\u7597\u7684\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u7b26\u5408\u6027\u548c\u7ba1\u7406\u4f53\u7cfb\u540c\u65f6\u6ee1\u8db3\u4e86\u7f8e\u56fd\uff08FDA\uff09\u3001\u52a0\u62ff\u5927\uff08HC\uff09\u3001\u5df4\u897f\uff08ANVISA\uff09\u3001\u6fb3\u5927\u5229\u4e9a\uff08TGA\uff09\u3001\u65e5\u672c\uff08MHLW & PMDA\uff09\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u90e8\u95e8\u5bf9\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u8981\u6c42\uff0c\u5c06\u4e3a\u535a\u8fc8\u4ea7\u54c1\u5728\u6d77\u5916\u5e02\u573a\u7684\u51c6\u5165\u5e26\u6765\u4fbf\u5229\u548c\u4f18\u52bf\uff0c\u8fdb\u4e00\u6b65\u52a0\u5feb\u5168\u7403\u5316\u53d1\u5c55\u7684\u6b65\u4f10\uff01<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">\u5173\u4e8eMDSAP\u5ba1\u6838\uff1a\u533b\u7597\u5668\u68b0\u5355\u4e00\u5ba1\u6838\u65b9\u6848\uff08Medical Device Single Audit Program \uff0c\u7f29\u5199\u4e3aMDSAP\uff09\u662f\u7531\u56fd\u9645\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u8bba\u575b\uff08IMDRF\uff09\u53d1\u8d77\uff0c\u4ee5ISO 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class=\"tadv-color\">2023\u5e74\u535a\u8fc8\u533b\u7597\u68c0\u6d4b\u4e2d\u5fc3\u83b7\u5f97\u4e86\u7531\u4e2d\u56fd\u5408\u683c\u8bc4\u5b9a\u56fd\u5bb6\u8ba4\u53ef\u59d4\u5458\u4f1a\u9881\u53d1\u7684CNAS\u5b9e\u9a8c\u5ba4\u8ba4\u53ef\u8bc1\u4e66\u3002\u83b7\u5f97\u5b9e\u9a8c\u5ba4\u56fd\u5bb6\u8ba4\u53ef\u8bc1\u4e66\uff0c\u6807\u5fd7\u7740\u516c\u53f8\u5b9e\u9a8c\u5ba4\u5177\u6709\u4e86\u56fd\u5bb6\u53ca\u56fd\u9645\u8ba4\u53ef\u7684\u7ba1\u7406\u6c34\u5e73\u548c\u68c0\u6d4b\u80fd\u529b\uff0c\u4e3a\u516c\u53f8\u4ea7\u54c1\u8d28\u91cf\u63d0\u4f9b\u4e86\u66f4\u6709\u529b\u7684\u6280\u672f\u548c\u54c1\u8d28\u4fdd\u969c\u652f\u6491\u3002\u4e5f\u8868\u660e\u4e86\u516c\u53f8\u5b9e\u9a8c\u5ba4\u5177\u5907\u4e86\u6309\u6709\u5173\u56fd\u9645\u51c6\u5219\u5f00\u5c55\u6821\u51c6\/\u68c0\u6d4b\u7684\u6280\u672f\u80fd\u529b\uff0c\u540c\u65f6CNAS\u8ba4\u53ef\u4e5f\u6709\u6548\u5730\u63d0\u9ad8\u4e86\u516c\u53f8\u5b9e\u9a8c\u5ba4\u7684\u7ba1\u7406\u6c34\u5e73\uff0c\u4fdd\u8bc1\u5b9e\u9a8c\u5ba4\u51fa\u5177\u7684\u68c0\u6d4b\u6570\u636e\u516c\u5e73\u6709\u6548\uff0c\u4e3a\u4ea7\u54c1\u7684\u7814\u53d1\u3001\u751f\u4ea7\u5236\u9020\u3001\u54c1\u8d28\u6027\u80fd\u7b49\u63d0\u4f9b\u66f4\u4e3a\u6709\u529b\u7684\u6280\u672f\u4fdd\u969c\uff01<\/span><\/p>\n\n\n\n<p><strong><span style=\"color:#000000\" class=\"tadv-color\">\u5e7f\u4e1c\u7701\u5546\u6807\u57f9\u80b2\u91d1\u5956<\/span><\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" width=\"1024\" height=\"675\" src=\"https:\/\/www.brosmed.com\/wp-content\/uploads\/2024\/01\/\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_17059059794971-1024x675.png\" alt=\"\" class=\"wp-image-8565\"\/><\/figure>\n\n\n\n<p class=\"has-black-color has-text-color\">2023\u5e74\u516d\u6708\uff0c<strong>\u5728\u7b2c\u4e00\u5c4a\u7ca4\u6e2f\u6fb3\u5927\u6e7e\u533a\uff08\u5e7f\u4e1c\uff09\u9ad8\u4ef7\u503c\u5546\u6807\u54c1\u724c\u57f9\u80b2\u5927\u8d5b\u7684\u8bc4\u9009\u4e2d\uff0c\u535a\u8fc8\u533b\u7597\u4ece\u4e0a\u5343\u5bb6\u53c2\u8bc4\u4f18\u79c0\u4f01\u4e1a\u4e2d\u8131\u9896\u800c\u51fa\uff0c\u8363\u83b7\u9996\u5c4a\u201c\u7ca4\u6e2f\u6fb3\u5927\u6e7e\u533a\u9ad8\u4ef7\u503c\u5546\u6807\u54c1\u724c\u57f9\u80b2\u91d1\u5956\u201d\u3002<\/strong>\u8fd9\u4efd\u8363\u8a89\u662f\u5bf9\u535a\u8fc8\u533b\u7597\u957f\u671f\u4ee5\u6765\u5bf9\u54c1\u724c\u5546\u6807\u57f9\u80b2\u5de5\u4f5c\u7684\u8ba4\u53ef\uff0c\u66f4\u8fdb\u4e00\u6b65\u5b9e\u73b0\u4e86\u5bf9\u535a\u8fc8\u54c1\u724c\u7684\u5168\u65b9\u4f4d\u4fdd\u62a4\uff0c\u6269\u5927\u54c1\u724c\u7684\u5f71\u54cd\u529b\uff0c\u594f\u54cd\u54c1\u724c\u5f3a\u97f3\uff01<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>\u5e7f\u4e1c\u7701\u79d1\u6280\u578b\u4e2d\u5c0f\u4f01\u4e1a<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" width=\"995\" height=\"402\" src=\"https:\/\/www.brosmed.com\/wp-content\/uploads\/2024\/01\/\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_17059060549049.png\" alt=\"\" class=\"wp-image-8566\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" width=\"1024\" height=\"206\" src=\"https:\/\/www.brosmed.com\/wp-content\/uploads\/2024\/01\/\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_17059060598373-1024x206.png\" alt=\"\" class=\"wp-image-8567\"\/><\/figure>\n\n\n\n<p class=\"has-black-color 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