{"id":8669,"date":"2025-09-30T22:52:16","date_gmt":"2025-09-30T14:52:16","guid":{"rendered":"https:\/\/be.tworg.app\/knowledge_base\/milestones\/"},"modified":"2025-11-22T10:13:00","modified_gmt":"2025-11-22T02:13:00","slug":"milestones","status":"publish","type":"knowledge_base","link":"https:\/\/behealthventures.com\/zh-hant\/knowledge_base\/milestones\/","title":{"rendered":"\u91ab\u7642\u5668\u6750\u7522\u54c1\u958b\u767c\u7684\u95dc\u9375\u91cc\u7a0b\u7891\uff08Milestones\uff09"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone wp-image-6489 size-full\" src=\"http:\/\/be.tworg.app\/wp-content\/uploads\/2025\/09\/bddb2813-7260-4ee6-aba9-0d4a455d592a.jpg\" alt=\"\" width=\"740\" height=\"470\" \/><\/p>\n<p>\u6bd4\u7ffc\u751f\u91ab\u5275\u6295\u91ab\u7642\u4e8b\u52d9\u526f\u7e3d \u6c88\u4fe1\u7def<\/p>\n<p>\u91ab\u7642\u5668\u6750\u7684\u958b\u767c\u662f\u4e00\u5834\u9ad8\u98a8\u96aa\u3001\u9577\u9031\u671f\u4e14\u9ad8\u76e3\u7ba1\u5bc6\u5ea6\u7684\u6311\u6230\u4e4b\u65c5\u3002\u6bcf\u4e00\u9805\u5275\u65b0\u7522\u54c1\u5f9e\u6982\u5ff5\u840c\u82bd\u5230\u4e0a\u5e02\u92b7\u552e\uff0c\u5fc5\u9808\u7a7f\u8d8a\u81e8\u5e8a\u9a57\u8b49\u3001\u6cd5\u898f\u5be9\u67e5\u3001\u88fd\u9020\u653e\u91cf\u8207\u5e02\u5834\u5c0e\u5165\u7b49\u591a\u91cd\u95dc\u5361\u3002\u6210\u529f\u7684\u91ab\u7642\u7522\u54c1\u958b\u767c\uff0c\u5f80\u5f80\u4f86\u81ea\u5c0d\u6bcf\u500b\u968e\u6bb5\u91cc\u7a0b\u7891\u7684\u7cbe\u6e96\u638c\u63e1\u8207\u7b56\u7565\u7ba1\u7406\u3002\u5c24\u5176\u5728\u7576\u4ee3\u9ad8\u9f61\u5316\u8207\u6162\u6027\u75c5\u76db\u884c\u7684\u793e\u6703\u4e2d\uff0c\u5e02\u5834\u5c0d\u65bc\u9ad8\u6548\u3001\u5b89\u5168\u3001\u53ef\u8ca0\u64d4\u7684\u91ab\u6750\u7522\u54c1\u9700\u6c42\u65e5\u589e\uff0c\u5982\u4f55\u7cfb\u7d71\u5316\u5730\u8d70\u5b8c\u958b\u767c\u6d41\u7a0b\uff0c\u5df2\u6210\u70ba\u65b0\u5275\u8207\u65e2\u6709\u91ab\u7642\u4f01\u696d\u5fc5\u5099\u7684\u57fa\u672c\u529f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u7522\u54c1\u958b\u767c\u521d\u671f\uff0c\u6700\u91cd\u8981\u7684\u662f\u78ba\u8a8d\u662f\u5426\u6709\u6e05\u6670\u7684\u81e8\u5e8a\u9700\u6c42\u3002\u9019\u901a\u5e38\u900f\u904e\u8207\u91ab\u7642\u73fe\u5834\u7684\u5c0d\u8a71\u3001\u89c0\u5bdf\u8207\u6587\u737b\u56de\u9867\u4f86\u9054\u6210\uff0c\u9032\u800c\u91d0\u6e05\u6240\u8b02\u7684\u300c\u672a\u88ab\u6eff\u8db3\u7684\u9700\u6c42\u300d\uff08Unmet Need\uff09\u3002\u8a31\u591a\u5275\u65b0\u767c\u60f3\u96d6\u5177\u5099\u6280\u8853\u4eae\u9ede\uff0c\u537b\u7f3a\u4e4f\u771f\u5be6\u81e8\u5e8a\u75db\u9ede\u652f\u6490\uff0c\u5c0e\u81f4\u7522\u54c1\u7121\u6cd5\u9032\u5165\u5e02\u5834\u3002\u56e0\u6b64\uff0c\u5728\u9019\u4e00\u968e\u6bb5\uff0c\u8207\u81e8\u5e8a\u7b2c\u4e00\u7dda\u4eba\u54e1\u9032\u884c\u6df1\u5ea6\u8a2a\u8ac7\u3001\u89c0\u5bdf\u91ab\u7642\u6d41\u7a0b\u4e2d\u300c\u88ab\u5ffd\u7565\u4f46\u53cd\u8986\u51fa\u73fe\u300d\u7684\u554f\u984c\uff0c\u5c07\u6709\u52a9\u65bc\u78ba\u8a8d\u9700\u6c42\u7684\u771f\u5be6\u6027\u8207\u6025\u8feb\u6027\u3002\u7576\u9700\u6c42\u7372\u5f97\u78ba\u8a8d\u5f8c\uff0c\u958b\u767c\u5718\u968a\u6703\u63d0\u51fa\u521d\u6b65\u7684\u89e3\u6c7a\u69cb\u60f3\uff0c\u4e26\u9032\u884c\u5e02\u5834\u8207\u7af6\u54c1\u5206\u6790\uff0c\u4ee5\u5efa\u7acb\u554f\u984c\u8207\u89e3\u6cd5\u4e4b\u9593\u7684\u5408\u7406\u9023\u7d50\u3002\u9019\u4e00\u968e\u6bb5\u7684\u6210\u679c\uff0c\u4e0d\u50c5\u5960\u5b9a\u4e86\u5f8c\u7e8c\u7522\u54c1\u8a2d\u8a08\u7684\u65b9\u5411\uff0c\u4e5f\u6709\u52a9\u65bc\u722d\u53d6\u65e9\u671f\u8cc7\u91d1\u8207\u7b56\u7565\u5408\u4f5c\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u7576\u6982\u5ff5\u6e05\u6670\u5f8c\uff0c\u63a5\u4e0b\u4f86\u9032\u5165\u6280\u8853\u53ef\u884c\u6027\u8a55\u4f30\u968e\u6bb5\u3002\u9019\u88e1\u7684\u91cd\u9ede\u5728\u65bc\u9a57\u8b49\u7522\u54c1\u5728\u6280\u8853\u4e0a\u662f\u5426\u5177\u5099\u53ef\u884c\u6027\uff0c\u5305\u62ec\u6750\u6599\u9078\u64c7\u3001\u88fd\u4f5c\u521d\u6b65\u539f\u578b\u3001\u6e2c\u8a66\u5176\u57fa\u672c\u529f\u80fd\u7b49\u3002\u540c\u6642\uff0c\u4e5f\u8981\u8207\u5de5\u7a0b\u8207\u4f9b\u61c9\u93c8\u5718\u968a\u8a55\u4f30\u88fd\u9020\u6210\u672c\u8207\u53ef\u91cf\u7522\u6027\u3002\u8a31\u591a\u5275\u696d\u5718\u968a\u5728\u6b64\u968e\u6bb5\u72af\u7684\u932f\u8aa4\uff0c\u662f\u5ffd\u7565\u65e9\u671f\u88fd\u9020\u898f\u6a21\u653e\u5927\u7684\u98a8\u96aa\u8207\u6311\u6230\uff0c\u5c0e\u81f4\u5f8c\u7e8c\u91cf\u7522\u56f0\u96e3\u6216\u6210\u672c\u904e\u9ad8\u3002\u6280\u8853\u53ef\u884c\u6027\u4e0d\u50c5\u662f\u80fd\u4e0d\u80fd\u505a\u5f97\u51fa\u4f86\uff0c\u66f4\u5728\u65bc\u9019\u500b\u65b9\u6848\u662f\u5426\u80fd\u5920\u5728\u54c1\u8cea\u3001\u6210\u672c\u3001\u6642\u9593\u4e09\u8005\u9593\u53d6\u5f97\u5e73\u8861\uff0c\u8b93\u7522\u54c1\u5177\u5099\u672a\u4f86\u8d70\u5411\u5546\u696d\u5316\u7684\u6f5b\u529b\u3002\u9019\u4e00\u968e\u6bb5\u82e5\u80fd\u5efa\u7acb\u521d\u6b65\u96db\u578b\uff0c\u4e26\u900f\u904e\u6a21\u64ec\u6e2c\u8a66\u7372\u5f97\u521d\u6b65\u9a57\u8b49\uff0c\u5c07\u70ba\u5f8c\u7e8c\u81e8\u5e8a\u8207\u6cd5\u898f\u968e\u6bb5\u63d0\u4f9b\u5f37\u529b\u652f\u6490\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u5728\u6280\u8853\u9010\u6f38\u6210\u578b\u4e4b\u969b\uff0c\u6cd5\u898f\u7b56\u7565\u4fbf\u6210\u70ba\u95dc\u9375\u3002\u6bcf\u500b\u570b\u5bb6\u7684\u91ab\u7642\u5668\u6750\u7686\u6709\u660e\u78ba\u5206\u985e\u8207\u5c0d\u61c9\u7684\u7533\u8acb\u8def\u5f91\uff0c\u56e0\u6b64\u9700\u8981\u6839\u64da\u7522\u54c1\u7684\u7528\u9014\u8207\u98a8\u96aa\u7b49\u7d1a\uff0c\u78ba\u8a8d\u6240\u5c6c\u7684\u985e\u5225\uff0c\u5982 Class I\u3001II \u6216 III\u3002\u4e0d\u540c\u5206\u985e\u5c0d\u61c9\u4e0d\u540c\u7684\u5be9\u67e5\u6a5f\u5236\u8207\u81e8\u5e8a\u8981\u6c42\uff0c\u6709\u4e9b\u53ef\u80fd\u53ef\u8d70\u7c21\u6613\u901a\u9053\uff08\u5982\u7f8e\u570b 510(k)\uff09\uff0c\u6709\u4e9b\u5247\u9700\u5b8c\u6574\u81e8\u5e8a\u8207 PMA \u8a55\u4f30\u3002\u5718\u968a\u9700\u8a55\u4f30\u76ee\u6a19\u5e02\u5834\u7684\u76e3\u7ba1\u8da8\u52e2\u8207\u5be9\u67e5\u91cd\u9ede\uff0c\u4f8b\u5982\u6b50\u76df MDR \u65b0\u6cd5\u898f\u5c0d\u8edf\u9ad4\u91ab\u6750\u7684\u7ba1\u7406\u66f4\u70ba\u56b4\u683c\u3002\u63d0\u65e9\u78ba\u8a8d\u6cd5\u898f\u7b56\u7565\uff0c\u624d\u80fd\u6709\u7cfb\u7d71\u5730\u5b89\u6392\u6240\u9700\u6e2c\u8a66\u9805\u76ee\u3001\u9810\u7559\u8cc7\u6e90\u8207\u898f\u5283\u6642\u7a0b\u3002\u6b64\u968e\u6bb5\u7684\u6e96\u5099\u7a0b\u5ea6\uff0c\u5e38\u5e38\u6c7a\u5b9a\u4e00\u9805\u7522\u54c1\u5f8c\u7e8c\u662f\u5426\u80fd\u5982\u671f\u9032\u5165\u5e02\u5834\u3001\u9806\u5229\u53d6\u5f97\u8b49\u7167\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u7576\u6cd5\u898f\u7b56\u7565\u78ba\u5b9a\u5f8c\uff0c\u8a2d\u8a08\u9a57\u8b49\u8207\u98a8\u96aa\u7ba1\u7406\u63a5\u8457\u5c55\u958b\u3002\u7522\u54c1\u958b\u767c\u5718\u968a\u9700\u6839\u64da\u5148\u524d\u5b9a\u7fa9\u7684\u8f38\u5165\u9700\u6c42\uff08Design Input\uff09\u8207\u7522\u51fa\u76ee\u6a19\uff08Design Output\uff09\uff0c\u5b8c\u6210\u591a\u9805\u8a2d\u8a08\u6e2c\u8a66\uff0c\u5305\u62ec\u6a5f\u69cb\u3001\u96fb\u5b50\u3001\u6027\u80fd\u8207\u751f\u7269\u76f8\u5bb9\u6027\u7b49\u9805\u76ee\u3002\u98a8\u96aa\u5206\u6790\u5982 FMEA \u4e5f\u662f\u6b64\u968e\u6bb5\u7684\u91cd\u8981\u5de5\u5177\uff0c\u7528\u4f86\u9810\u6e2c\u8207\u6e1b\u5c11\u672a\u4f86\u4f7f\u7528\u4e2d\u53ef\u80fd\u767c\u751f\u7684\u5931\u6548\u60c5\u5883\u3002\u6b64\u968e\u6bb5\u9664\u4e86\u6280\u8853\u57f7\u884c\u529b\uff0c\u66f4\u8003\u9a57\u5718\u968a\u662f\u5426\u5177\u5099\u300c\u7cfb\u7d71\u6027\u601d\u7dad\u300d\u2014\u2014\u5982\u4f55\u5728\u78ba\u4fdd\u5b89\u5168\u6027\u8207\u5408\u898f\u6027\u7684\u540c\u6642\uff0c\u4e0d\u5931\u7522\u54c1\u7684\u5275\u65b0\u6027\u8207\u81e8\u5e8a\u9069\u7528\u6027\u3002\u8a2d\u8a08\u9a57\u8b49\u7684\u5b8c\u6574\u8207\u5426\uff0c\u4e5f\u5c07\u662f\u5f8c\u7e8c\u5be9\u67e5\u6a5f\u95dc\u662f\u5426\u653e\u884c\u7684\u6838\u5fc3\u4f9d\u64da\uff0c\u56e0\u6b64\u7d55\u4e0d\u80fd\u8349\u7387\u61c9\u5c0d\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u81e8\u5e8a\u9a57\u8b49\u5247\u662f\u9032\u4e00\u6b65\u78ba\u8a8d\u7522\u54c1\u5728\u5be6\u969b\u4f7f\u7528\u4e2d\u7684\u5b89\u5168\u6027\u8207\u6709\u6548\u6027\u3002\u6839\u64da\u7522\u54c1\u98a8\u96aa\u7b49\u7d1a\uff0c\u53ef\u80fd\u53ea\u9700\u7c21\u6613\u89c0\u5bdf\u6027\u7814\u7a76\uff0c\u6216\u9700\u7d93\u904e\u5b8c\u6574\u7684\u81e8\u5e8a\u8a66\u9a57\u3002\u8a66\u9a57\u8a08\u756b\u9700\u9001\u4ea4\u502b\u7406\u59d4\u54e1\u6703\uff08IRB\uff09\u53ca\u4e3b\u7ba1\u6a5f\u95dc\u6838\u51c6\uff0c\u4e26\u9075\u5faa GCP 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