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\u7279\u306b\u5c0f\u898f\u6a21\u306a\u30c1\u30fc\u30e0\u3067\u306f\u3001\u3059\u3079\u3066\u306e\u5206\u91ce\u306b\u7cbe\u901a\u3057\u305f\u4eba\u6750\u3092\u793e\u5185\u306b\u305d\u308d\u3048\u308b\u3053\u3068\u306f\u56f0\u96e3\u3067\u3059\u3002\u5916\u90e8\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306f\u3001\u7279\u5b9a\u306e\u8ab2\u984c\u306b\u5fc5\u8981\u306a\u30b9\u30ad\u30eb\u3092\u30d4\u30f3\u30dd\u30a4\u30f3\u30c8\u3067\u88dc\u3046\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002 \u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u3092\u6d3b\u7528\u3059\u308b4\u3064\u306e\u30e1\u30ea\u30c3\u30c8 1. \u5fc5\u8981\u306a\u5c02\u9580\u77e5\u8b58\u306b\u3059\u3050\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b \u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3001510(k)\u3001EU MDR\u3001ISO 13485\u3001ISO 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