\u533b\u7642\u6a5f\u5668\u306e\u591a\u69d8\u306a\u4e16\u754c\u3067\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3059\u306b\u306f\u3001\u5de7\u307f\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u308c\u306f\u96e3\u3057\u304f\u8907\u96d1\u306a\u4ed5\u4e8b\u3067\u3059\u3002\u4e88\u7b97\u5185\u3067\u53b3\u3057\u3044\u671f\u9650\u3092\u5b88\u308a\u306a\u304c\u3089\u3001\u591a\u304f\u306e\u7570\u306a\u308b\u95a2\u4fc2\u8005\u306e\u30cb\u30fc\u30ba\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u53d6\u3089\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u30cb\u30fc\u30ba\u3068\u5b89\u5168\u6027\u306f\u6700\u3082\u91cd\u8981\u3067\u3042\u308a\u3001\u305d\u308c\u3092\u5b9f\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002. <\/p>\n\n\n\n
\u8fc5\u901f\u3067\u7af6\u4e89\u529b\u306e\u3042\u308b\u898b\u7a4d\u3082\u308a<\/p>\n\n\n\n
\u8fc5\u901f\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u958b\u59cb<\/p>\n\n\n\n
\u6a5f\u6750\u3078\u306e\u8fc5\u901f\u306a\u30a2\u30af\u30bb\u30b9<\/p>\n\n\n\n
\u52b9\u7387\u7684\u306a\u914d\u4fe1\u3068\u30ec\u30dd\u30fc\u30c8<\/p>\n\n\n\n
ISO17025\u304a\u3088\u3073GMP\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002\u3054\u5951\u7d04\uff08\u767a\u6ce8\u66f8\u3001\u4f5c\u696d\u660e\u7d30\u66f8\u3001\u6280\u8853\u5951\u7d04\u66f8\uff09\u304c\u6210\u7acb\u3057\u307e\u3057\u305f\u3089\u3001\u6570\u65e5\u4ee5\u5185\u306b\u304a\u5ba2\u69d8\u306e\u627f\u8a8d\u307e\u305f\u306f\u30b3\u30e1\u30f3\u30c8\u3092\u5f97\u308b\u305f\u3081\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u3054\u8fd4\u4fe1\u3044\u305f\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n
\u533b\u7642\u6a5f\u5668\u306e\u8a66\u9a13\u3068\u306f\u3001\u305d\u306e\u6a5f\u5668\u304c\u4f7f\u7528\u6642\u306b\u78ba\u5b9f\u304b\u3064\u5b89\u5168\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u5b9f\u8a3c\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3002. <\/strong>\u65b0\u88fd\u54c1\u958b\u767a\u3067\u306f\u3001\u5e83\u7bc4\u306a\u30c7\u30b6\u30a4\u30f3\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a66\u9a13\u304c\u9069\u7528\u3055\u308c\u308b\u3002\u3053\u308c\u306b\u306f\u3001\u6027\u80fd\u8a66\u9a13\u3001\u6bd2\u6027\u8a66\u9a13\u3001\u5316\u5b66\u5206\u6790\u3001\u305d\u3057\u3066\u6642\u306b\u306f\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u8a66\u9a13\u3084\u81e8\u5e8a\u8a66\u9a13\u3082\u542b\u307e\u308c\u308b\u3002\u7d99\u7d9a\u7684\u306a\u54c1\u8cea\u4fdd\u8a3c\u8a66\u9a13\u306f\u3001\u4e00\u822c\u7684\u306b\u3082\u3063\u3068\u9650\u5b9a\u7684\u3067\u3042\u308b\u3002\u3053\u308c\u306b\u306f\u901a\u5e38\u3001\u5bf8\u6cd5\u30c1\u30a7\u30c3\u30af\u3001\u3044\u304f\u3064\u304b\u306e\u6a5f\u80fd\u8a66\u9a13\u3001\u5305\u88c5\u691c\u8a3c\u306a\u3069\u304c\u542b\u307e\u308c\u308b\u3002.<\/p>\n\n\n\n \u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u30fb\u30c6\u30b9\u30c8<\/p>\n\n\n\n \u5f53\u7814\u7a76\u6240\u3067\u306f\u3001\u8868\u9762\u63a5\u89e6\u578b\u304b\u3089\u6c38\u4e45\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u307e\u3067\u3001\u307e\u305f\u81ea\u52d5\u6ce8\u5c04\u5668\u304b\u3089\u30b9\u30d7\u30ec\u30fc\u3084\u30af\u30ea\u30fc\u30e0\u307e\u3067\u3001\u85ac\u7269\u9001\u9054\u88fd\u54c1\u306b\u81f3\u308b\u307e\u3067\u3001\u591a\u7a2e\u591a\u69d8\u306a\u533b\u7642\u6a5f\u5668\u3092\u6271\u3063\u3066\u304d\u305f\u8c4a\u5bcc\u306a\u7d4c\u9a13\u304c\u3042\u308a\u307e\u3059\u3002\u30e9\u30dc\u8a66\u9a13- \u7d9a\u304d\u3092\u8aad\u3080...<\/p>\n\n\n\n \u6750\u6599\u8a66\u9a13<\/p>\n\n\n\n \u6750\u6599\u306e\u7279\u6027\u8a55\u4fa1\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u3068\u88fd\u9020\u306b\u591a\u304f\u306e\u5fdc\u7528\u304c\u3042\u308b\u3002\u3053\u308c\u306f\u3001\u300c\u6307\u7d0b\u300d\u3092\u8b58\u5225\u3059\u308b\u305f\u3081\u306e\u6750\u6599\u306e\u5316\u5b66\u5206\u6790\u3067\u3042\u308b\u3002\u3053\u306e\u60c5\u5831\u306f\u3001\u65b0\u898f\u8a2d\u8a08\u306e\u6bd2\u7269\u5b66\u7684\u8a66\u9a13\u3092\u6700\u5c0f\u5316\u3059\u308b\u305f\u3081\u3001\u307e\u305f\u88fd\u9020\u3084\u8a2d\u8a08\u5909\u66f4\u306e\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u3002\u5316\u5b66\u7684\u540c\u5b9a\u306f\u3001\u53d7\u5165\u539f\u6750\u6599\u3084\u30ed\u30c3\u30c8\u9593\u751f\u7523\u306b\u3082\u9069\u7528\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002. <\/p>\n\n\n\n \u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13<\/p>\n\n\n\n \u533b\u7642\u6a5f\u5668\u306b\u306f\u3001\u305d\u306e\u5206\u985e\u306b\u5fdc\u3058\u3066\u69d8\u3005\u306a\u7a0b\u5ea6\u306e\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u304c\u8981\u6c42\u3055\u308c\u308b\u3002\u751f\u7269\u5b66\u7684\u5b89\u5168\u6027\u306e\u5fc5\u9808\u8981\u4ef6\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u4e3b\u306a\u60c5\u5831\u6e90\u306f\u3001ISO 10993 - Biological evaluation of medical devices\uff08\u533b\u7642\u6a5f\u5668\u306e\u751f\u7269\u5b66\u7684\u8a55\u4fa1\uff09\u3067\u3059\u3002\u3053\u306e\u898f\u683c\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u4fb5\u8972\u6027\u3068\u60a3\u8005\u3068\u306e\u63a5\u89e6\u6642\u9593\u306e\u89b3\u70b9\u304b\u3089\u533b\u7642\u6a5f\u5668\u3092\u5b9a\u7fa9\u3057\u3066\u304a\u308a\u3001\u305d\u306e\u7d50\u679c\u3001\u533b\u7642\u6a5f\u5668\u306e\u4e0a\u5e02\u306b\u5148\u7acb\u3061\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u3069\u306e\u30ec\u30d9\u30eb\u306e\u5b89\u5168\u6027\u8a66\u9a13\u3092\u6210\u529f\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u304c\u6c7a\u5b9a\u3055\u308c\u307e\u3059\u3002\u5b89\u5168\u6027\u8a66\u9a13- \u7d9a\u304d\u3092\u8aad\u3080<\/p>\n\n\n\n \u30d5\u30a1\u30fc\u30b9\u30c8\u30e9\u30a4\u30f3QA<\/p>\n\n\n\n \u88fd\u54c1\u3078\u306e\u30af\u30ec\u30fc\u30e0\u304c\u4eba\u624b\u3092\u6d6a\u8cbb\u3057\u3001\u4ed6\u306b\u4f7f\u3044\u305f\u3044\u30ea\u30bd\u30fc\u30b9\u3092\u6d88\u8cbb\u3057\u3066\u3044\u307e\u305b\u3093\u304b\uff1f\u9867\u5ba2\u304b\u3089\u306e\u8fd4\u54c1\u306f\u30d3\u30b8\u30cd\u30b9\u306e\u5fc5\u7136\u7684\u306a\u90e8\u5206\u3067\u3059\u304c\u3001\u8cb4\u793e\u306b\u3068\u3063\u3066\u4e0d\u53ef\u6b20\u306a\u90e8\u5206\u3067\u3042\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\uff01\u5f53\u793e\u72ec\u81ea\u306e\u30d5\u30a1\u30fc\u30b9\u30c8\u30e9\u30a4\u30f3QA\u30b5\u30fc\u30d3\u30b9\u306b\u3088\u308a\u3001\u300c\u6b27\u5dde\u5e02\u5834\u3067\u8ca9\u58f2\u3059\u308b\u88fd\u9020\u696d\u8005\u306f\u3001\u81ea\u8b66\u3092\u5fb9\u5e95\u3059\u3079\u304d\u3067\u3042\u308b\u300d\u3068\u898f\u5b9a\u3059\u308bEU MEDDEV 2.12-1 Rev 5\u300c\u533b\u7642\u6a5f\u5668\u81ea\u8b66\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\u306b\u7c21\u5358\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u82e6\u60c5\u5206\u6790- \u7d9a\u304d\u3092\u8aad\u3080...<\/p>\n\n\n\n 2021\u5e745\u670826\u65e5\u3001\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08MDD\uff09\u306f\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR\uff09\u306b\u53d6\u3063\u3066\u4ee3\u308f\u3089\u308c\u305f\u3002MDR\u306fMDD\u306e\u6539\u826f\u7248\u3092\u610f\u56f3\u3057\u3066\u304a\u308a\u3001\u4e3b\u306a\u9055\u3044\u306f\u3001MDR\u304c\u898f\u5236\u3068\u3057\u3066\u3059\u3079\u3066\u306eEU\u52a0\u76df\u56fd\u3067\u306e\u76f4\u63a5\u5b9f\u65bd\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u308b\u3053\u3068\u3067\u3042\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001MDR\u306f\u5168\u52a0\u76df\u56fd\u306b\u3068\u3063\u3066\u5747\u4e00\u304b\u3064\u516c\u5e73\u306a\u898f\u5236\u3092\u4f5c\u308a\u51fa\u3057\u3001\u54c1\u8cea\u3068\u5b89\u5168\u5bfe\u7b56\u306e\u57fa\u6e96\u3092\u9ad8\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p>\n\n\n\n MDR\u306fEU\u306e\u5168\u52a0\u76df\u56fd\u306b\u9069\u7528\u3055\u308c\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3088\u3063\u3066\u3001\u4f01\u696d\u306f\u73fe\u5728\u306e\u88fd\u54c1\u885b\u751f\u3068\u5b89\u5168\u6027\u3092\u6539\u5584\u3059\u308b\u3088\u3046\u4fc3\u3055\u308c\u308b\u3002.<\/p>\n\n\n\n \u540c\u898f\u5236\u306e\u898f\u5b9a\u3067\u306f\u3001\u4f01\u696d\u306f\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3092\u898b\u76f4\u3057\u3001\u898f\u5236\u3092\u9075\u5b88\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u5909\u66f4\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/p>\n\n\n\n \u533b\u7642\u6a5f\u5668\u306f\u3001\u4f7f\u7528\u8005\u3001\u60a3\u8005\u3001\u7b2c\u4e09\u8005\u306e\u5065\u5eb7\u3092\u5b88\u308b\u305f\u3081\u306b\u3001\u3044\u304f\u3064\u304b\u306e\u898f\u5236\u8981\u4ef6\u306e\u5bfe\u8c61\u3068\u306a\u3063\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n \u3053\u3053\u306b\u6700\u3082\u91cd\u8981\u306a\u8981\u4ef6\u3092\u5217\u6319\u3057\u305f\uff1a<\/p>\n\n\n\n DIN EN ISO 14155\u306b\u6e96\u62e0\u3057\u305f\u5c02\u7528\u8a66\u9a13\u8a08\u753b\u306e\u8a3c\u660e<\/p>\n\n\n\n \u5f53\u8a72\u88fd\u54c1\u306e\u5b89\u5168\u6027\u306e\u8a3c\u660e<\/p>\n\n\n\n \u7ba1\u8f44\u9ad8\u7b49\u9023\u90a6\u5f53\u5c40BfArM\u306e\u627f\u8a8d\uff08MPG\u7b2c22a\u6761\uff09<\/p>\n\n\n\n \u502b\u7406\u59d4\u54e1\u4f1a\u306b\u3088\u308b\u627f\u8a8d<\/p>\n\n\n\n \u60a3\u8005\u306e\u60c5\u5831\u3068\u540c\u610f<\/p>\n\n\n\n \u30d7\u30ed\u30d6\u30e9\u30f3\u30c9\u4fdd\u967a\u306e\u7de0\u7d50<\/p>\n\n\n\n \u7c73\u56fd\u3067\u306f\u3001FDA\u306e\u533b\u7642\u6a5f\u5668\u30fb\u653e\u5c04\u7dda\u885b\u751f\u30bb\u30f3\u30bf\u30fc\uff08CDRH\uff09\u304c\u3001\u7c73\u56fd\u5185\u3067\u88fd\u9020\u30fb\u8ca9\u58f2\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u3092\u62c5\u5f53\u3057\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n \u7c73\u56fd\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001\u30af\u30e9\u30b9\uff08I\u3001II\u3001III\uff09\u306b\u3088\u3063\u3066\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u30af\u30e9\u30b9\u306b\u3088\u3063\u3066\u3001\u305d\u306e\u6a5f\u5668\u3084\u6280\u8853\u304c\u3069\u306e\u3088\u3046\u306a\u898f\u5236\u8981\u4ef6\u306b\u5f93\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u304c\u6c7a\u307e\u308a\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u88fd\u9020\u696d\u8005\u3068\u8ca9\u58f2\u696d\u8005\u306f\u300110\u67081\u65e5\u304b\u308912\u670831\u65e5\u306e\u9593\u306bFDA\u306b\u767b\u9332\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u533b\u7642\u6a5f\u5668\u3092\u767b\u9332\u3059\u308b\u969b\u306b\u306f\u3001\u5305\u88c5\u696d\u8005\u3001\u88fd\u9020\u696d\u8005\u3001\u30e9\u30d9\u30eb\u8cbc\u4ed8\u696d\u8005\u3001\u958b\u767a\u696d\u8005\u3001\u6ec5\u83cc\u696d\u8005\u306a\u3069\u3001\u88fd\u54c1\u306e\u88fd\u9020\u306b\u95a2\u308f\u308b\u3059\u3079\u3066\u306e\u4f01\u696d\u3092\u30ea\u30b9\u30c8\u30a2\u30c3\u30d7\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n \u3042\u306a\u305f\u306e\u533b\u7642\u6a5f\u5668\u304c\u3069\u306e\u30af\u30e9\u30b9\u306b\u5c5e\u3059\u308b\u304b\u306b\u3088\u3063\u3066\u3001PMA\u5be9\u67fb\u3084\u7b2c\u4e09\u8005\u5be9\u67fb\u306a\u3069\u306e\u4ed6\u306e\u898f\u5236\u3068\u3068\u3082\u306b\u3001\u5e02\u8ca9\u524d\u5c4a\u51fa\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n \u7c73\u56fd\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u4eba\u306e\u50b7\u5bb3\u3084\u6b7b\u4ea1\u3092\u5f15\u304d\u8d77\u3053\u3057\u305f\u3001\u3042\u308b\u3044\u306f\u305d\u306e\u4e00\u56e0\u3068\u306a\u3063\u305f\u4e8b\u6545\u306f\u3059\u3079\u3066\u3001FDA\u306b\u5831\u544a\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3002\u3059\u3079\u3066\u306e\u4e0d\u5177\u5408\u306f\u3001\u4fee\u6b63\u3055\u308c\u308b\u3088\u3046\u306b\u5831\u544a\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n \u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30c6\u30b9\u30c8\u306b\u7279\u5316\u3057\u305f\u898f\u5236\u304c\u3044\u304f\u3064\u304b\u3042\u308b\u3002\u3053\u308c\u3089\u306e\u898f\u5236\u306f\u3001\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u4fe1\u983c\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u305d\u306e\u7d50\u679c\u306f\u4e00\u822c\u7684\u306bFDA\u306b\u63d0\u51fa\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n \u91cd\u8981\u306a\u898f\u5236\u306e\u4e00\u3064\u306b\u3001FDA\u306e\u300c\u533b\u7642\u6a5f\u5668\u306b\u542b\u307e\u308c\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5e02\u8ca9\u524d\u7533\u8acb\u306e\u5185\u5bb9\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u300d\u304c\u3042\u308b\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4f7f\u7528\u76ee\u7684\u306e\u8a73\u7d30\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u30cf\u30b6\u30fc\u30c9\u5206\u6790\u3001\u30c6\u30b9\u30c8\u30d7\u30ed\u30c8\u30b3\u30eb\u306a\u3069\u3001\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5e02\u8ca9\u524d\u7533\u8acb\u306b\u542b\u3081\u308b\u3079\u304d\u60c5\u5831\u306e\u6982\u8981\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n \u3082\u3046\u4e00\u3064\u306e\u91cd\u8981\u306a\u898f\u5236\u306f\u3001FDA\u306eGeneral Principles of Software Validation\u3067\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u306b\u4f7f\u7528\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u3002\u3053\u306e\u898f\u5236\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3001\u6587\u66f8\u5316\u3001\u30c6\u30b9\u30c8\u65b9\u6cd5\u306a\u3069\u306e\u30c8\u30d4\u30c3\u30af\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n \u3053\u308c\u3089\u306e\u898f\u5236\u306b\u52a0\u3048\u3066\u3001FDA\u306f\u65e2\u5b58\u306e\u533b\u7642\u6a5f\u5668\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u5909\u66f4\u306b\u95a2\u3059\u308b\u7279\u5b9a\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u7528\u610f\u3057\u3066\u3044\u308b\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u3059\u3067\u306b\u5e02\u8ca9\u3055\u308c\u3066\u3044\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u5909\u66f4\u3092\u52a0\u3048\u308b\u969b\u306b\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u5f93\u3046\u3079\u304d\u30d7\u30ed\u30bb\u30b9\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n \u7a4d\u6975\u7684\u306a\u59ff\u52e2\u3067\u3001\u9867\u5ba2\u306e\u5229\u76ca\u3092\u91cd\u8996\u3057\u3001\u9867\u5ba2\u306e\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u88fd\u54c1\u3092\u7d99\u7d9a\u7684\u306b\u6539\u5584\u3057\u3001\u5b89\u5168\u6027\u3001\u4fe1\u983c\u6027\u3001\u74b0\u5883\u4fdd\u8b77\u8981\u4ef6\u3001\u304a\u3088\u3073\u6280\u8853\u9769\u65b0\u306b\u3055\u3089\u306b\u6ce8\u610f\u3092\u6255\u3063\u3066\u3044\u307e\u3059\u3002 \u6d78\u900f\u6027\u8a66\u9a13\u6a5f<\/a>,\u91dd\u5165\u5ea6\u8a66\u9a13\u6cd5<\/a>,\u533b\u7642\u88fd\u54c1\u691c\u67fb\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc<\/a>,\u533b\u7642\u6a5f\u5668\u30c6\u30b9\u30bf\u30fc<\/a>,\u5f15\u5f35\u8a66\u9a13\u6a5f\u30e1\u30fc\u30ab\u30fc<\/a>,\u624b\u52d5\u5f0f\u70ad\u9178\u30ac\u30b9\u30c6\u30b9\u30bf\u30fc<\/a>,CO2\u91cf\u30c6\u30b9\u30bf\u30fc<\/a>,\u533b\u7642\u7528\u7a7f\u523a\u30c6\u30b9\u30bf\u30fc<\/a>,\u30e1\u30eb\u30c8\u30d5\u30ed\u30fc\u30a4\u30f3\u30c7\u30c3\u30af\u30b9\u30c6\u30b9\u30bf\u30fc\u4fa1\u683c<\/a>,\u6c34\u5e73\u5f15\u5f35\u8a66\u9a13\u6a5f \u4f9b\u7d66\u8005<\/a>,\u96fb\u52d5\u30ad\u30e3\u30c3\u30d7\u30c8\u30eb\u30af\u30c6\u30b9\u30bf\u30fc<\/a>,\u30c8\u30eb\u30af\u8a66\u9a13\u6a5f<\/a><\/p>","protected":false},"excerpt":{"rendered":" Medical Device Function and Performance Testing Meeting regulatory requirements in the varied world of medical devices requires deft project management. This can be a difficult and complex job. You have to balance the needs of a lot of different parties whilst staying within budget and holding to tight deadlines. The clinical needs and safety of the device are paramount and must be demonstrated. Rapid and competitive quotations Rapid project commencement Rapid access to equipment Efficient delivery and reporting We work to ISO 17025 and GMP. Once a contract is in place (purchase order, statement of work or technical agreement) we will respond with a protocol for your approval or comment […]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1124","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.materialstests.com\/ja\/wp-json\/wp\/v2\/posts\/1124","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.materialstests.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.materialstests.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.materialstests.com\/ja\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.materialstests.com\/ja\/wp-json\/wp\/v2\/comments?post=1124"}],"version-history":[{"count":0,"href":"https:\/\/www.materialstests.com\/ja\/wp-json\/wp\/v2\/posts\/1124\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.materialstests.com\/ja\/wp-json\/wp\/v2\/media?parent=1124"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.materialstests.com\/ja\/wp-json\/wp\/v2\/categories?post=1124"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.materialstests.com\/ja\/wp-json\/wp\/v2\/tags?post=1124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\u533b\u7642\u6a5f\u5668\u8a66\u9a13<\/h2>\n\n\n\n
\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u304a\u3051\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30c6\u30b9\u30c8\u5b8c\u5168\u30ac\u30a4\u30c9<\/h2>\n\n\n\n
<\/h3>\n\n\n\n