{"id":11424,"date":"2026-05-14T11:54:38","date_gmt":"2026-05-14T03:54:38","guid":{"rendered":"https:\/\/www.behealthventures.com\/?post_type=knowledge_base&p=11424"},"modified":"2026-05-14T11:54:38","modified_gmt":"2026-05-14T03:54:38","slug":"fda-%e5%af%a9%e6%9f%a5%e8%a6%96%e8%a7%92%ef%bd%9cai-samd-%e5%a6%82%e4%bd%95%e8%90%bd%e5%9c%b0-iec-62304%ef%bc%9f%e8%a8%ad%e8%a8%88%e7%ae%a1%e5%88%b6%e8%88%87-traceability-matrix-%e7%9a%84%e6%9c%80","status":"publish","type":"knowledge_base","link":"https:\/\/behealthventures.com\/zh-hant\/knowledge_base\/fda-%e5%af%a9%e6%9f%a5%e8%a6%96%e8%a7%92%ef%bd%9cai-samd-%e5%a6%82%e4%bd%95%e8%90%bd%e5%9c%b0-iec-62304%ef%bc%9f%e8%a8%ad%e8%a8%88%e7%ae%a1%e5%88%b6%e8%88%87-traceability-matrix-%e7%9a%84%e6%9c%80\/","title":{"rendered":"FDA \u5be9\u67e5\u8996\u89d2\uff5cAI SaMD \u5982\u4f55\u843d\u5730 IEC 62304\uff1f\u8a2d\u8a08\u7ba1\u5236\u8207 Traceability Matrix \u7684\u6700\u5c0f\u53ef\u884c\u67b6\u69cb\u00a0"},"content":{"rendered":"

 <\/p>\n

\"\"<\/p>\n

\u00a0<\/span><\/p>\n

\u6bd4\u7ffc\u751f\u91ab\u5275\u6295\u00a0\u6295\u8cc7\u66a8\u81e8\u5e8a\u7b56\u7565\u526f\u7e3d\u00a0\u6c88\u4fe1\u7def<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

AI\u00a0SaMD<\/span>\uff08\u4eba\u5de5\u667a\u6167\u91ab\u7642\u8edf\u9ad4\uff09\u8981\u6210\u529f\u53d6\u8b49\u3001\u901a\u904e<\/span>\u00a0IEC 62304<\/span>\uff0c\u6700\u5bb9\u6613\u5361\u4f4f\u7684\u5f80\u5f80\u4e0d\u662f\u6a21\u578b\u6e96\u78ba\u7387\u4e0d\u5920\uff0c\u800c\u662f\u5718\u968a\u8a66\u5716\u628a<\/span>\u00a0AI\u00a0<\/span>\u7684\u975e\u78ba\u5b9a\u6027\u786c\u585e\u9032\u4e00\u5957\u539f\u672c\u70ba\u78ba\u5b9a\u6027\u8edf\u9ad4\u8a2d\u8a08\u7684\u751f\u547d\u9031\u671f\u6846\u67b6\u88e1\uff0c\u6700\u5f8c\u7528\u4e00\u5806\u770b\u4f3c\u5b8c\u6574\u3001\u4f46\u6839\u672c\u4e0d\u53ef\u7dad\u8b77\u7684\u6587\u4ef6\u628a\u81ea\u5df1\u62d6\u57ae\u3002\u771f\u6b63\u53ef\u843d\u5730\u7684\u7b56\u7565\u53ea\u6709\u4e00\u500b\uff0c\u628a<\/span>\u00a0AI\u00a0<\/span>\u7684\u975e\u78ba\u5b9a\u6027\u6a21\u7d44\u5305\u5728\u78ba\u5b9a\u6027\u6846\u67b6\u5167\uff0c\u7528\u6700\u5c0f\u4f46\u5b8c\u6574\u7684\u8a2d\u8a08\u7ba1\u5236\u8207<\/span>\u00a0Traceability<\/span>\uff08\u8ffd\u6eaf\uff09\u7d50\u69cb\uff0c\u8b93\u5be9\u67e5\u55ae\u4f4d\u770b\u5f97\u61c2\u98a8\u96aa\uff0c\u4e5f\u8b93\u5718\u968a\u63a7\u5f97\u4f4f\u6210\u672c\u8207\u958b\u767c\u7bc0\u594f\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u4e00\u3001\u5148\u5b9a\u7fa9\u00a0AI\u00a0\u7684\u8eab\u5206\uff0c\u5b83\u4e0d\u662f\u4f8b\u5916\uff0c\u5b83\u662f\u00a0Software Item\u00a0<\/strong><\/p>\n

IEC 62304\u00a0<\/span>\u4e0d\u6703\u56e0\u70ba\u4f60\u7528\u4e86<\/span>\u00a0AI\u00a0<\/span>\u5c31\u6539\u8b8a\u904a\u6232\u898f\u5247\uff0c\u5b83\u95dc\u5fc3\u7684\u6838\u5fc3\u59cb\u7d42\u662f\u5169\u4ef6\u4e8b\uff1a\u8edf\u9ad4\u5b89\u5168\u5206\u985e\uff08<\/span>A<\/span>\u3001<\/span>B<\/span>\u3001<\/span>C<\/span>\uff09\u8207\u751f\u547d\u9031\u671f\u6d3b\u52d5\u3002\u56e0\u6b64\uff0c\u5728\u6587\u4ef6\u7684\u7b2c\u4e00\u6bb5\u5c31\u8981\u628a<\/span>\u00a0AI\u00a0<\/span>\u6a21\u7d44\u653e\u56de<\/span>\u00a0IEC 62304\u00a0<\/span>\u7684\u8a9e\u8a00\u7cfb\u7d71\u88e1\uff1a<\/span>AI\u00a0<\/span>\u6a21\u7d44\u901a\u5e38\u88ab\u7576\u6210\u8edf\u9ad4\u9805\uff08<\/span>Software Item<\/span>\uff09\u6216\u8edf\u9ad4\u6a21\u7d44\uff0c\u9019\u610f\u5473\u8457\u5b83\u4e00\u6a23\u8981\u8d70\u5b89\u5168\u5206\u985e\u3001\u8a2d\u8a08\u63a7\u5236\u3001\u7248\u672c\u8207\u66f4\u65b0\u7ba1\u7406\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u9019\u500b\u5b9a\u4f4d\u4e0d\u662f\u5f62\u5f0f\u554f\u984c\uff0c\u800c\u662f\u5be9\u67e5\u908f\u8f2f\u554f\u984c\u3002\u7576\u4f60\u628a<\/span>\u00a0AI\u00a0<\/span>\u5b9a\u7fa9\u6210<\/span>\u00a0Software Item<\/span>\uff0c\u4f60\u5728\u5be9\u67e5\u8005\u773c\u4e2d\u5c31\u4e0d\u662f\u5728\u8cbb\u529b\u89e3\u91cb\u795e\u7d93\u7db2\u8def\uff0c\u800c\u662f\u5728\u8aaa\u660e\u5982\u4f55\u628a\u4e00\u500b\u9ad8\u98a8\u96aa\u9ed1\u7bb1\u6a21\u7d44\u653e\u9032\u6574\u9ad4\u7cfb\u7d71\u6cbb\u7406\uff0c\u505a\u5230\u53ef\u9a57\u8b49\uff08<\/span>Verifiable<\/span>\uff09\u3001\u53ef\u8ffd\u6eaf\uff08<\/span>Traceable<\/span>\uff09\u3001\u53ef\u56de\u6efe\uff08<\/span>Rollbackable<\/span>\uff09\u3002\u66f4\u73fe\u5be6\u7684\u662f\uff0c\u5b89\u5168\u5206\u985e\u4e00\u65e6\u88ab\u4f4e\u4f30\uff0c\u5f8c\u7e8c\u6240\u6709\u6587\u4ef6\u8207\u6e2c\u8a66\u7b56\u7565\u90fd\u6703\u88ab\u5f37\u70c8\u8cea\u7591\u3002\u5c24\u5176\u662f\u6d89\u53ca\u8a3a\u65b7\u6216\u6cbb\u7642\u6c7a\u7b56\u7684<\/span>\u00a0AI<\/span>\uff0c\u5be6\u52d9\u4e0a\u5e38\u843d\u5728<\/span>\u00a0Class B\u00a0<\/span>\u6216<\/span>\u00a0Class C<\/span>\u3002\u5206\u985e\u4e0d\u53ea\u662f\u6cd5\u898f\u9078\u9805\uff0c\u5b83\u76f4\u63a5\u6c7a\u5b9a\u4f60\u672a\u4f86\u6e2c\u8a66\u8b49\u64da\u7684\u6210\u672c\u7d50\u69cb\u8207\u4e0a\u5e02\u6642\u9593\u8868\uff0c\u4e5f\u6c7a\u5b9a\u4f60\u5728\u5be9\u67e5\u904e\u7a0b\u4e2d\u6703\u88ab\u8ffd\u554f\u5230\u4ec0\u9ebc\u6df1\u5ea6\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u4e8c\u3001\u8a2d\u8a08\u7ba1\u5236\u7684\u00a0MVP\uff0c\u7528\u4e00\u689d\u6700\u77ed\u8def\u5f91\u7acb\u8d77\u00a0DHF\u00a0\u9aa8\u67b6\u00a0<\/strong>
\n\u00a0<\/span><\/p>\n

IEC 62304\u00a0<\/span>\u7684\u8a2d\u8a08\u7ba1\u5236\uff0c\u5be6\u52d9\u4e0a\u5c31\u662f\u628a\u8edf\u9ad4\u958b\u767c\u6d41\u7a0b\u8207\u98a8\u96aa\u63a7\u5236\u7d81\u6210\u540c\u4e00\u689d\u7dda\uff0c\u9019\u500b\u6700\u5c0f\u9aa8\u67b6\u53ef\u4ee5\u76f4\u63a5\u5c0d\u61c9\u5230<\/span>\u00a0DHF<\/span>\uff08\u8a2d\u8a08\u6b77\u53f2\u6a94\u6848\uff09\u7684\u96db\u5f62\u3002\u4f60\u8981\u7684\u4e0d\u662f\u4e00\u6574\u5ea7\u6587\u4ef6\u5c71\uff0c\u800c\u662f\u4e00\u689d\u5be9\u67e5\u80fd\u8d70\u5f97\u901a\u7684\u8def\u5f91\uff0c\u4e26\u4e14\u6bcf\u4e00\u6b65\u90fd\u80fd\u5f80\u4e0b\u63a5\u5230\u8b49\u64da\u3002\u6700\u77ed\u8def\u5f91\u53ef\u4ee5\u6536\u6582\u6210\uff1a<\/span>SRS<\/span>\u3001<\/span>SAD<\/span>\u3001<\/span>SDS<\/span>\u3001\u5be6\u4f5c\u3001<\/span>V&V<\/span>\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u843d\u5730\u6642\u52d9\u5fc5\u6293\u4f4f\u4e09\u500b\u6700\u5bb9\u6613\u88ab\u770b\u61c2\u7684\u8a2d\u8a08\u52d5\u4f5c\u3002\u5be9\u67e5\u8005\u770b\u7684\u4e0d\u662f\u4f60\u5beb\u4e86\u591a\u5c11\u9801\uff0c\u800c\u662f\u4f60\u6709\u6c92\u6709\u628a\u4e0d\u78ba\u5b9a\u6027\u6536\u6582\u6210\u53ef\u63a7\u7684\u5de5\u7a0b\u884c\u70ba\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u7b2c\u4e00\u500b\u52d5\u4f5c\uff0c<\/span>SRS\u00a0<\/span>\u5148\u628a<\/span>\u00a0AI\u00a0<\/span>\u9700\u6c42\u5beb\u6210\u53ef\u9a57\u8b49\u7684\u7cfb\u7d71\u884c\u70ba<\/span>
\n\u00a0<\/span><\/p>\n

\u5728\u7cfb\u7d71\u9700\u6c42\u898f\u683c\uff08<\/span>SRS<\/span>\uff09\u4e2d\uff0c\u4e0d\u8981\u53ea\u5beb<\/span>\u00a0AI\u00a0<\/span>\u6703\u5075\u6e2c\u75c5\u7076\uff0c\u800c\u662f\u8981\u628a<\/span>\u00a0AI\u00a0<\/span>\u7684\u4e0d\u78ba\u5b9a\u6027\u8f49\u6210\u7cfb\u7d71\u53ef\u63a7\u7684\u898f\u5247\u3002\u4f60\u53ef\u4ee5\u660e\u78ba\u5beb\u51fa\uff1a<\/span>AI\u00a0<\/span>\u6a21\u7d44\u8f38\u51fa\u5fc5\u9808\u9644\u5e36\u7f6e\u4fe1\u5ea6\uff0c\u53ea\u6709\u5728\u7f6e\u4fe1\u5ea6\u9054\u5230\u9810\u8a2d\u9580\u6abb\u6642\u624d\u53ef\u88ab\u7cfb\u7d71\u63a1\u7d0d\uff1b\u7576\u7f6e\u4fe1\u5ea6\u4f4e\u65bc\u9580\u6abb\u6642\uff0c\u7cfb\u7d71\u5fc5\u9808\u9032\u5165\u964d\u7d1a\u6a21\u5f0f\u6216\u8981\u6c42\u4eba\u5de5\u8986\u6838\u3002\u91cd\u9ede\u4e0d\u5728\u9580\u6abb\u6578\u5b57\u662f<\/span>\u00a00.8\u00a0<\/span>\u9084\u662f<\/span>\u00a00.75<\/span>\uff0c\u800c\u662f\u4f60\u80fd\u628a\u98a8\u96aa\u63a7\u5236\u5beb\u6210\u53ef\u9a57\u8b49\u3001\u53ef\u6e2c\u8a66\u7684\u7cfb\u7d71\u884c\u70ba\u3002\u9019\u4e00\u6b65\u7684\u771f\u6b63\u76ee\u7684\uff0c\u662f\u628a\u6a21\u578b\u8868\u73fe\u7684\u4e0d\u78ba\u5b9a\u8b8a\u6210\u7cfb\u7d71\u884c\u70ba\u7684\u78ba\u5b9a\uff0c\u8b93\u5be9\u67e5\u55ae\u4f4d\u628a\u98a8\u96aa\u63a7\u5236\u7406\u89e3\u6210\u8a2d\u8a08\u7684\u4e00\u90e8\u5206\uff0c\u800c\u4e0d\u662f\u628a\u98a8\u96aa\u4e1f\u7d66\u6a21\u578b\u53bb\u8ced\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u7b2c\u4e8c\u500b\u52d5\u4f5c\uff0c<\/span>SAD\u00a0<\/span>\u628a<\/span>\u00a0AI\u00a0<\/span>\u62bd\u8c61\u6210\u9ed1\u7bb1\u670d\u52d9\uff0c\u4ecb\u9762\u5b9a\u7fa9\u8981\u56b4\u683c<\/span>
\n\u00a0<\/span><\/p>\n

\u5728\u8edf\u9ad4\u67b6\u69cb\u8a2d\u8a08\uff08<\/span>SAD<\/span>\uff09\u5c64\uff0c\u4e0d\u9700\u8981\u628a\u6a21\u578b\u7d50\u69cb\u6524\u958b\u4f86\u8b1b\uff0c\u4f46\u5fc5\u9808\u628a\u5b83\u8b8a\u6210\u53ef\u6cbb\u7406\u7684\u670d\u52d9\u6a21\u7d44\u3002\u4f60\u81f3\u5c11\u8981\u628a\u4ee5\u4e0b\u908a\u754c\u689d\u4ef6\u8b1b\u6e05\u695a\uff0c\u4e26\u4e14\u8b93\u5b83\u53ef\u6aa2\u67e5\u3001\u53ef\u88ab\u6e2c\u8a66\uff1a<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u7b2c\u4e00\uff0c\u8f38\u5165\u662f\u4ec0\u9ebc\uff0c\u683c\u5f0f\u8207\u5141\u8a31\u7bc4\u570d\u70ba\u4f55\uff0c\u5305\u542b\u5f71\u50cf\u6216\u8a0a\u865f\u7684\u898f\u683c\u3001\u7f3a\u6f0f\u503c\u8655\u7406\u3001\u4f8b\u5916\u60c5\u5883<\/span>
\n\u7b2c\u4e8c\uff0c\u524d\u8655\u7406\u600e\u9ebc\u505a\uff0c\u54ea\u4e9b\u6b65\u9a5f\u662f\u56fa\u5b9a\u898f\u5247\uff0c\u54ea\u4e9b\u6b65\u9a5f\u6703\u5f71\u97ff\u6a21\u578b\u8f38\u51fa<\/span>
\n\u7b2c\u4e09\uff0c\u8f38\u51fa\u9577\u4ec0\u9ebc\u6a23\uff0c\u5fc5\u9808\u662f\u7d50\u69cb\u5316\u7d50\u679c\uff0c\u4e26\u5b9a\u7fa9\u5fc5\u8981\u6b04\u4f4d\uff0c\u4f8b\u5982\u5206\u985e\u7d50\u679c\u3001\u5b9a\u4f4d\u7d50\u679c\u3001\u7f6e\u4fe1\u5ea6\u3001\u8b66\u793a\u6a19\u8a18<\/span>
\n\u7b2c\u56db\uff0c\u4ecb\u9762\u5354\u8b70\u5982\u4f55\u5b9a\u7fa9\uff0c\u5305\u542b<\/span>\u00a0API\u00a0<\/span>\u7c3d\u540d\u3001\u7248\u672c\u3001\u76f8\u5bb9\u6027\u8207\u56de\u6eaf\u7b56\u7565<\/span>
\n\u7b2c\u4e94\uff0c\u932f\u8aa4\u78bc\u8207\u8d85\u6642\u6a5f\u5236\u600e\u9ebc\u8655\u7406\uff0c\u7cfb\u7d71\u5728\u5931\u6557\u6216\u5ef6\u9072\u6642\u8981\u9032\u5165\u4ec0\u9ebc\u72c0\u614b<\/span>
\n\u7b2c\u516d\uff0c\u7f6e\u4fe1\u5ea6\u9580\u6abb\u5982\u4f55\u88ab\u7cfb\u7d71\u6d88\u5316\uff0c\u4f4e\u7f6e\u4fe1\u5ea6\u6642\u7684\u6d41\u7a0b\u8207\u756b\u9762\u63d0\u793a\u3001\u7d00\u9304\u8207\u7a3d\u6838\u8ecc\u8de1<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u5be9\u67e5\u8005\u8981\u770b\u5230\u7684\u662f\u4f60\u628a\u9ed1\u7bb1\u7684\u908a\u754c\u9396\u4f4f\u4e86\u3002\u5373\u4f7f\u6a21\u578b\u4e0d\u53ef\u5b8c\u5168\u89e3\u91cb\uff0c\u4f60\u4ecd\u80fd\u7528\u5de5\u7a0b\u908a\u754c\u689d\u4ef6\u8b93\u7cfb\u7d71\u5728\u5931\u6548\u6642\u4fdd\u6301\u53ef\u63a7\uff0c\u4e26\u4e14\u628a\u98a8\u96aa\u63a7\u5236\u843d\u5728\u7cfb\u7d71\u5c64\uff0c\u800c\u4e0d\u662f\u628a\u8cac\u4efb\u63a8\u56de\u7d66\u6a21\u578b\u672c\u8eab\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u7b2c\u4e09\u500b\u52d5\u4f5c\uff0c<\/span>SDS\u00a0<\/span>\u662f\u898f\u7bc4\u5316\uff0c\u800c\u4e0d\u662f\u9010\u884c\u89e3\u91cb<\/span>
\n\u00a0<\/span><\/p>\n

\u6700\u5c0f\u53ef\u884c\u7684\u8edf\u9ad4\u8a73\u7d30\u8a2d\u8a08\uff08<\/span>SDS<\/span>\uff09\uff0c\u91cd\u9ede\u662f\u628a<\/span>\u00a0AI\u00a0<\/span>\u6a21\u7d44\u8b8a\u6210\u53ef\u5be9\u8a08\u7684\u5de5\u7a0b\u7269\u4ef6\u3002\u4f60\u4e0d\u9700\u8981\u9010\u884c\u89e3\u91cb\u795e\u7d93\u7db2\u8def\uff0c\u800c\u662f\u8981\u5efa\u7acb\u53ef\u91cd\u73fe\u3001\u53ef\u56de\u6eaf\u7684\u63a7\u5236\u9ede\uff0c\u81f3\u5c11\u80fd\u56de\u7b54\u300c\u9019\u500b\u6a21\u578b\u5982\u4f55\u88ab\u5b9a\u7fa9\u3001\u5982\u4f55\u88ab\u5efa\u7f6e\u3001\u5982\u4f55\u88ab\u91cd\u8dd1\u300d\u3002\u56e0\u6b64<\/span>\u00a0SDS\u00a0<\/span>\u81f3\u5c11\u61c9\u63cf\u8ff0\u4ee5\u4e0b\u5167\u5bb9\uff0c\u4e26\u4e14\u7528\u4e00\u81f4\u7684\u7248\u672c\u63a7\u7ba1\u4e32\u8d77\u4f86\uff1a<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u7b2c\u4e00\uff0c\u6a21\u578b\u67b6\u69cb\u985e\u578b\u8207\u5176\u9650\u5236\u689d\u4ef6\uff0c\u4f8b\u5982\u662f\u5206\u985e\u3001\u5075\u6e2c\u3001\u5206\u5272\uff0c\u662f\u5426\u5305\u542b\u524d\u5f8c\u8655\u7406\u7ba1\u7dda<\/span>
\n\u7b2c\u4e8c\uff0c\u8f38\u5165\u8f38\u51fa\u683c\u5f0f\u8207\u524d\u5f8c\u8655\u7406\u898f\u7bc4\uff0c\u5305\u542b\u6b63\u898f\u5316\u3001\u88c1\u5207\u3001\u53bb\u566a\u3001\u7279\u5fb5\u8403\u53d6\u7b49\u56fa\u5b9a\u898f\u5247<\/span>
\n\u7b2c\u4e09\uff0c\u8a13\u7df4\u8cc7\u6599\u4f86\u6e90\u8207\u6a19\u8a3b\u54c1\u8cea\u63a7\u7ba1\uff0c\u5305\u542b\u6a19\u8a3b\u6e96\u5247\u3001\u6a19\u8a3b\u8005\u8cc7\u683c\u3001\u4e92\u8a55\u4e00\u81f4\u6027\u8207\u8cc7\u6599\u6392\u9664\u898f\u5247<\/span>
\n\u7b2c\u56db\uff0c\u8cc7\u6599\u5206\u5272\u7b56\u7565\uff0c\u81f3\u5c11\u8981\u8aaa\u6e05\u695a<\/span>\u00a0train<\/span>\u3001<\/span>validation<\/span>\u3001<\/span>test\u00a0<\/span>\u7684\u5207\u5206\u539f\u5247\uff0c\u4ee5\u53ca\u5916\u90e8\u8cc7\u6599\u6216\u8de8\u9662\u8cc7\u6599\u7684\u5b9a\u4f4d\u8207\u4f7f\u7528\u65b9\u5f0f<\/span>
\n\u7b2c\u4e94\uff0c\u8a13\u7df4\u6d41\u7a0b\u7684\u6846\u67b6\u5c64\u8a2d\u8a08\uff0c\u5305\u542b\u95dc\u9375\u8d85\u53c3\u6578\u7684\u7248\u672c\u5316\u3001\u96a8\u6a5f\u7a2e\u5b50\u3001\u8a13\u7df4\u74b0\u5883\u8207\u4f9d\u8cf4\u5957\u4ef6\u7684\u53ef\u8ffd\u6eaf<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u4f60\u4e0d\u662f\u5728\u5beb\u5b78\u8853\u8ad6\u6587\uff0c\u800c\u662f\u5728\u5efa\u7acb\u5de5\u7a0b\u6cbb\u7406\u3002\u4f60\u8981\u8b93\u4efb\u4f55\u4e00\u6b21\u91cd\u8dd1\u90fd\u80fd\u56de\u7b54\u4e00\u500b\u51b7\u9177\u7684\u554f\u984c\uff1a\u9019\u4efd\u7d50\u679c\u662f\u4e0d\u662f\u5728\u540c\u4e00\u5957\u5de5\u7a0b\u689d\u4ef6\u4e0b\u53ef\u518d\u73fe\uff0c\u4e26\u4e14\u53ef\u88ab\u7a3d\u6838\u8ffd\u6eaf\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u4e09\u3001\u7248\u672c\u8207\u8b8a\u66f4\u7ba1\u7406\uff0c\u628a\u00a0Retraining\u00a0\u7576\u6210\u8edf\u9ad4\u66f4\u65b0\uff0c\u4f60\u5c31\u6703\u7a81\u7136\u8b8a\u5f97\u5408\u898f\u00a0<\/strong>
\n\u00a0<\/span><\/p>\n

AI\u00a0SaMD<\/span>\u00a0\u6700\u5e38\u898b\u7684\u6b7b\u7a74\u662f\u6a21\u578b\u8fed\u4ee3\u5f88\u5feb\uff0c\u4f46\u7248\u672c\u4e0d\u53ef\u56de\u6eaf\u3002<\/span>IEC 62304\u00a0<\/span>\u7684\u843d\u5730\u89e3\u6cd5\u5176\u5be6\u5f88\u76f4\u767d\uff1a\u6bcf\u4e00\u6b21\u8a13\u7df4\u6216\u91cd\u65b0\u8a13\u7df4\uff08<\/span>Retraining<\/span>\uff09\uff0c\u90fd\u8996\u70ba\u4e00\u6b21\u8edf\u9ad4\u66f4\u65b0\uff0c\u5fc5\u9808\u6709\u66f4\u65b0\u8a08\u756b\u8207\u56de\u6efe\u7b56\u7565\u3002\u7248\u672c\u547d\u540d\u7d55\u5c0d\u4e0d\u80fd\u53ea\u5beb\u6210<\/span>\u00a0v1.2\u00a0<\/span>\u9019\u7a2e\u5167\u90e8\u6a19\u7c64\uff0c\u800c\u662f\u8981\u628a\u6a21\u578b\u7248\u672c\u8207\u8a13\u7df4\u8cc7\u6599\u96c6\u7248\u672c\u3001\u8d85\u53c3\u6578\u7248\u672c\u7dca\u7dca\u7d81\u5b9a\u5728\u4e00\u8d77\uff0c\u8b93\u4f60\u80fd\u5728\u4efb\u4f55\u6642\u523b\u56de\u7b54\u300c\u73fe\u5728\u4e0a\u5e02\u7684\u662f\u54ea\u4e00\u500b\u6a21\u578b\u300d\u300c\u5b83\u662f\u7528\u54ea\u4e00\u6279\u8cc7\u6599\u8a13\u7df4\u300d\u300c\u7528\u4e86\u54ea\u4e9b\u8d85\u53c3\u6578\u300d\u300c\u548c\u4e0a\u4e00\u7248\u5dee\u5728\u54ea\u88e1\u300d\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u9019\u6bb5\u770b\u4f3c\u662f\u5de5\u7a0b\u7ba1\u7406\uff0c\u5be6\u969b\u4e0a\u662f\u8de8\u570b\u5408\u898f\u7684\u5171\u540c\u8a9e\u8a00\u3002\u7f8e\u570b<\/span>\u00a0FDA\u00a0<\/span>\u95dc\u5fc3\u7684\u662f\u4f60\u80fd\u5426\u8aaa\u6e05\u695a\u4e0a\u5e02\u7248\u672c\u3001\u8b8a\u66f4\u5f8c\u7248\u672c\u7684\u5dee\u7570\uff0c\u4ee5\u53ca\u98a8\u96aa\u63a7\u5236\u662f\u5426\u4ecd\u6210\u7acb\u3002\u6b50\u76df<\/span>\u00a0MDR\u00a0<\/span>\u7b49\u5e02\u5834\u5247\u66f4\u5728\u610f\u4f60\u662f\u5426\u628a\u8b8a\u66f4\u6cbb\u7406\u5beb\u9032<\/span>\u00a0QMS<\/span>\uff0c\u4e26\u4e14\u80fd\u5728\u7a3d\u6838\u6642\u628a\u7248\u672c\u8207\u8b49\u64da\u93c8\u4e00\u53e3\u6c23\u62c9\u51fa\u4f86\u3002\u5c0d\u516c\u53f8\u6cbb\u7406\u8207\u6295\u8cc7\u4eba\u800c\u8a00\uff0c\u9019\u4e5f\u662f\u672a\u4f86\u6295\u5f8c\u7a3d\u6838\u8207\u4f75\u8cfc\u76e1\u8077\u8abf\u67e5\u6700\u5e38\u88ab\u62bd\u67e5\u7684\u4e00\u6bb5\uff0c\u56e0\u70ba\u5b83\u6c7a\u5b9a\u4e86\u4f60\u7684\u8b49\u64da\u80fd\u4e0d\u80fd\u88ab\u4fe1\u4efb\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/strong><\/p>\n

\u56db\u3001V&V\u00a0\u7684\u6700\u5c0f\u843d\u5730\uff0c\u975e\u00a0AI\u00a0\u8d70\u55ae\u5143\u6e2c\u8a66\uff0cAI\u00a0\u8d70\u7aef\u5230\u7aef\u8207\u6027\u80fd\u8b49\u64da\u00a0<\/strong>
\n\u00a0<\/span><\/p>\n

\u5f88\u591a\u5718\u968a\u628a\u9a57\u8b49\u8207\u78ba\u8a8d\uff08<\/span>V&V<\/span>\uff09\u5beb\u5f97\u592a\u904e\u8907\u96dc\uff0c\u5c0e\u81f4\u6700\u5f8c\u9023\u81ea\u5df1\u90fd\u7121\u6cd5\u7dad\u8b77\u3002\u6700\u5c0f\u53ef\u884c\u7684\u505a\u6cd5\u53cd\u800c\u66f4\u8cbc\u8fd1\u5be9\u67e5\u8005\u601d\u7dad\uff0c\u4f60\u53ef\u4ee5\u628a\u5b83\u62c6\u6210\u4e09\u5c64\uff0c\u8b93\u8b49\u64da\u93c8\u4e7e\u6de8\u53ef\u8b80\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u7b2c\u4e00\u5c64\uff0c\u975e<\/span>\u00a0AI\u00a0<\/span>\u6a21\u7d44\u63a1\u7528\u6a19\u6e96\u55ae\u5143\u6e2c\u8a66\uff0c\u78ba\u4fdd\u8cc7\u6599\u7ba1\u7dda\u3001\u4ecb\u9762\u3001\u898f\u5247\u908f\u8f2f\u3001<\/span>UI\u00a0<\/span>\u5448\u73fe\u8207\u4f8b\u5916\u8655\u7406\u5728\u6bcf\u6b21\u66f4\u65b0\u5f8c\u90fd\u53ef\u88ab\u81ea\u52d5\u9a57\u8b49<\/span>
\n\u7b2c\u4e8c\u5c64\uff0c<\/span>AI\u00a0<\/span>\u6a21\u7d44\u7528\u7aef\u5230\u7aef\u6e2c\u8a66\u8207\u6027\u80fd\u6307\u6a19\u6e2c\u8a66\uff0c\u5c0d\u61c9\u4f60\u5ba3\u7a31\u7684\u81e8\u5e8a\u7528\u9014\uff0c\u4e26\u4e14\u628a\u6027\u80fd\u6307\u6a19\u7d81\u56de\u98a8\u96aa\u63a7\u5236\u9700\u6c42<\/span>
\n\u7b2c\u4e09\u5c64\uff0c\u7cfb\u7d71\u5c64\u5f80\u4e0a\u505a\u6574\u5408\u6e2c\u8a66\u8207\u7cfb\u7d71\u9a57\u8b49\uff0c\u805a\u7126\u4ecb\u9762\u5354\u5b9a\u3001\u908a\u754c\u60c5\u5883\u3001\u964d\u7d1a\u6d41\u7a0b\u8207\u4eba\u5de5\u8986\u6838\u6d41\u7a0b\u662f\u5426\u78ba\u5be6\u88ab\u89f8\u767c\uff0c\u4ee5\u53ca\u5728\u81e8\u5e8a\u6216\u6a21\u64ec\u8cc7\u6599\u4e0a\u662f\u5426\u80fd\u7dad\u6301\u5ba3\u7a31\u7684\u611f\u5ea6\u3001\u7279\u7570\u5ea6\u6216\u5176\u4ed6\u95dc\u9375\u6307\u6a19<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u95dc\u9375\u4e0d\u5728\u65bc\u4f60\u505a\u4e86\u591a\u5c11\u6e2c\u8a66\uff0c\u800c\u5728\u65bc\u4f60\u662f\u5426\u80fd\u628a<\/span>\u00a0AI\u00a0<\/span>\u7684\u4e0d\u78ba\u5b9a\u6027\u95dc\u9032\u53ef\u91cf\u6e2c\u7684\u6027\u80fd\u6307\u6a19\u8207\u53ef\u9a57\u8b49\u7684\u7cfb\u7d71\u884c\u70ba\u88e1\u3002\u7576\u4f60\u5728<\/span>\u00a0SRS\u00a0<\/span>\u5b9a\u7fa9\u4e86\u7f6e\u4fe1\u5ea6\u9580\u6abb\u8207\u964d\u7d1a\u6a21\u5f0f\uff0c\u4f60\u5728<\/span>\u00a0V&V\u00a0<\/span>\u5c31\u5fc5\u9808\u8b49\u660e\u5169\u4ef6\u4e8b\uff1a\u9ad8\u7f6e\u4fe1\u5ea6\u6642\u6027\u80fd\u9054\u6a19\uff0c\u4f4e\u7f6e\u4fe1\u5ea6\u6642\u7cfb\u7d71\u884c\u70ba\u78ba\u5be6\u89f8\u767c\u8986\u6838\u6216\u964d\u7d1a\uff0c\u800c\u4e14\u6574\u5408\u4ecb\u9762\u4e0d\u6703\u5728\u908a\u754c\u60c5\u5883\u4e0b\u5931\u6548\u3002\u5be9\u67e5\u8005\u8981\u770b\u5230\u7684\u662f\u4f60\u7528\u63a7\u5236\u7d50\u69cb\u5728\u7ba1\u7406\u98a8\u96aa\uff0c\u800c\u4e0d\u662f\u9760\u5ba3\u7a31\u5728\u8aaa\u670d\u98a8\u96aa\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u4e94\u3001Traceability Matrix\u00a0\u7684\u00a0MVP\u00a0\u4e0d\u662f\u5de8\u91cf\u4ea4\u53c9\u8868\uff0c\u800c\u662f\u4e00\u689d\u53ef\u5be9\u8a08\u7684\u8b49\u64da\u93c8\u00a0<\/strong>
\n\u00a0<\/span><\/p>\n

Traceability\u00a0<\/span>\u7684\u6700\u5c0f\u53ef\u884c\u5b9a\u7fa9\u53ea\u6709\u4e00\u53e5\u8a71\uff1a\u5f9e\u98a8\u96aa\u5230\u8b49\u64da\u8981\u80fd\u8d70\u51fa\u4e00\u689d\u7dda\u3002\u4f60\u4e0d\u9700\u8981\u8017\u8cbb\u5fc3\u529b\u7dad\u8b77\u5de8\u91cf\u4e14\u7121\u6548\u7684\u5168\u4ea4\u53c9\u8868\uff0c\u53ea\u8981\u78ba\u4fdd\u6bcf\u4e00\u689d\u98a8\u96aa\u90fd\u80fd\u5c0d\u61c9\u5230\u81f3\u5c11\u4e00\u500b\u9700\u6c42\u3001\u8a2d\u8a08\u9805\u3001\u6e2c\u8a66\u6848\u4f8b\u8207\u8b49\u64da\u6587\u4ef6\u5373\u53ef\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u5be6\u52d9\u4e0a\u5f37\u70c8\u5efa\u8b70\u628a<\/span>\u00a0Traceability\u00a0<\/span>\u4e3b\u8868\u7576\u6210\u552f\u4e00\u771f\u76f8\u4f86\u6e90\u3002\u4e3b\u8868\u6700\u5c0f\u6b04\u4f4d\u5efa\u8b70\u7528\u689d\u5217\u65b9\u5f0f\u6e05\u695a\u5b9a\u7fa9\uff0c\u4e26\u4e14\u5728\u6587\u4ef6\u4e2d\u56fa\u5b9a\u7528\u540c\u4e00\u5957\u547d\u540d\u898f\u5247\uff1a<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u7b2c\u4e00\uff0c<\/span>Risk ID<\/span>\uff0c\u5c0d\u61c9<\/span>\u00a0ISO 14971\u00a0<\/span>\u98a8\u96aa\u689d\u76ee<\/span>
\n\u7b2c\u4e8c\uff0c<\/span>Requirement ID<\/span>\uff0c\u5c0d\u61c9<\/span>\u00a0SRS\u00a0<\/span>\u7cfb\u7d71\u9700\u6c42<\/span>
\n\u7b2c\u4e09\uff0c<\/span>Design Item ID<\/span>\uff0c\u5c0d\u61c9<\/span>\u00a0SAD\u00a0<\/span>\u6216<\/span>\u00a0SDS\u00a0<\/span>\u7684\u6a21\u7d44\u8a2d\u8a08<\/span>
\n\u7b2c\u56db\uff0c<\/span>Test Case ID<\/span>\uff0c\u5c0d\u61c9<\/span>\u00a0V&V\u00a0<\/span>\u6e2c\u8a66\u6848\u4f8b<\/span>
\n\u7b2c\u4e94\uff0c<\/span>Evidence Location<\/span>\uff0c\u6307\u5411\u5831\u544a\u6216\u6a94\u6848\u4f4d\u7f6e\uff0c\u5fc5\u9808\u53ef\u88ab\u5b58\u53d6\u8207\u7a3d\u6838\u8ffd\u6eaf<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

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\u00a0<\/span><\/p>\n

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