{"id":1476,"date":"2022-08-15T01:44:35","date_gmt":"2022-08-15T01:44:35","guid":{"rendered":"https:\/\/www.mandreel.com\/japan\/?page_id=1476"},"modified":"2022-08-15T02:04:15","modified_gmt":"2022-08-15T02:04:15","slug":"iso13485","status":"publish","type":"page","link":"https:\/\/www.mandreel.com\/japan\/iso13485\/","title":{"rendered":"ISO13485\u3068\u306f\uff1f\u5206\u304b\u308a\u3084\u3059\u304f\u8aac\u660e\u3057\u307e\u3059\u3002"},"content":{"rendered":"

[vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column]\r\n

\r\n
\r\n
\r\n
\r\n
\r\n
\r\n <\/span>\r\n

ISO13485\u30ac\u30a4\u30c9\uff1a\u533b\u7642\u6a5f\u5668\u898f\u683c\u3092\u7406\u89e3\u3059\u308b<\/h2>\r\n
<\/div>\r\n <\/div>\r\n\r\n
\r\n ISO13485\u306b\u3088\u308a\u5236\u5b9a\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u898f\u683c\u304c\u6700\u8fd1\u66f4\u65b0\u3055\u308c\u305f\u3053\u3068\u306f\u3054\u5b58\u77e5\u3067\u3057\u3087\u3046\u304b\u3002\u4eca\u56de\u306e\u6539\u5b9a\u306f\u4ee5\u524d\u3068\u5927\u304d\u304f\u7570\u306a\u308a\u307e\u3059\u306e\u3067\u3001\u5bfe\u5fdc\u306e\u305f\u3081\u306b\u4f01\u696d\u306f\u5341\u5206\u306a\u6e96\u5099\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n

\u3053\u306e\u8a18\u4e8b\u306f\u3001\u533b\u7642\u6a5f\u5668\u898f\u683c\u306e\u5909\u66f4\u304c\u30d3\u30b8\u30cd\u30b9\u306b\u53ca\u307c\u3059\u5f71\u97ff\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u3042\u306a\u305f\u306e\u4f01\u696d\u306b\u95a2\u9023\u304c\u3042\u308b\u5834\u5408\u306f\u7a76\u6975\u306e\u30ac\u30a4\u30c9\u3068\u3057\u3066\u304a\u5f79\u7acb\u3066\u304f\u3060\u3055\u3044\u3002\r\n\r\n

\r\n \r\n \"\"\r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n\r\n
\r\n
\r\n \r\n \"about-img\"\r\n \r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>[\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column]\r\n
\r\n
<\/div>\r\n <\/div>[\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column]\r\n
\r\n
\r\n
\r\n
\r\n
\r\n \r\n \"about-img1\"\r\n \r\n \r\n <\/div>\r\n <\/div>\r\n\r\n
\r\n
\r\n
\r\n <\/span>\r\n

ISO 13485\u3068\u306f\uff1f<\/h2>\r\n
<\/div>\r\n <\/div>\r\n\r\n
\r\n
\r\n <\/i>\r\n <\/div>\r\n ISO13485:2013\u306f\u533b\u7642\u6a5f\u5668\u306e\u56fd\u969b\u898f\u683c\u3067\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6761\u4ef6\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n

ISO13485\u306f\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u8a2d\u8a08\u306b\u3088\u308a\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u304c\u4fdd\u305f\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u898f\u683c\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u8a66\u9a13\u3001\u305d\u3057\u3066\u6587\u66f8\u5316\u306b\u3064\u3044\u3066\u6700\u4f4e\u9650\u306e\u8981\u6c42\u4e8b\u9805\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n

ISO 13485\u3092\u5c0e\u5165\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u4fe1\u983c\u6027\u3001\u5b89\u5168\u6027\u3001\u305d\u3057\u3066\u6709\u52b9\u6027\u304c\u5411\u4e0a\u3059\u308b\u3068\u3044\u3046\u30e1\u30ea\u30c3\u30c8\u304c\u3042\u308a\u307e\u3059\u3002\u5f53\u898f\u683c\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u53d6\u308a\u6271\u3046\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5b9a\u7684\u306a\u751f\u7523\u3068\u6700\u9ad8\u57fa\u6e96\u306e\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308b\u306e\u3067\u3059\u3002\r\n\r\n

\r\n \r\n \"\"\r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n
\r\n \r\n \"shape\"\r\n \r\n <\/div>\r\n\r\n <\/div>\r\n [\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column]\r\n
\r\n
\r\n
\r\n
\r\n
\r\n
\r\n <\/span>\r\n

ISO13485\u8a8d\u8a3c\u304c\u5fc5\u8981\u306a\u533b\u7642\u6a5f\u5668\u3068\u306f\uff1f<\/h2>\r\n
<\/div>\r\n <\/div>\r\n\r\n
\r\n \u690d\u8fbc\u307f\u578b\u9664\u7d30\u52d5\u5668\u3001\u4eba\u5de5\u547c\u5438\u5668\u3001\u30ab\u30c6\u30fc\u30c6\u30eb\u306a\u3069\u7279\u5b9a\u306e\u7a2e\u985e\u306e\u533b\u7642\u6a5f\u5668\u306b\u304a\u3044\u3066\u306fISO13485\u8a8d\u8a3c\u306e\u53d6\u5f97\u304c\u5fc5\u9808\u6761\u4ef6\u3068\u306a\u308a\u307e\u3059\u3002\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u3092\u958b\u767a\u3059\u308b\u5834\u5408\u3082ISO 13485\u8a8d\u8a3c\u306e\u8981\u4ef6\u3092\u7406\u89e3\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n

ISO13485\u898f\u683c\u306f\u533b\u7642\u6a5f\u5668\u306e\u9ad8\u3044\u54c1\u8cea\u3068\u3001\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u8981\u4ef6\u3078\u306e\u9069\u5408\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u958b\u767a\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n

\u307e\u305f\u3001\u533b\u7642\u6a5f\u5668\u3092\u6b27\u5dde\u3084\u305d\u306e\u4ed6\u306e\u5730\u57df\u3067\u8ca9\u58f2\u3059\u308b\u5834\u5408\u3082\u8a8d\u8a3c\u306e\u53d6\u5f97\u306f\u5fc5\u9808\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306eCE\u30de\u30fc\u30af\u53d6\u5f97\u306b\u3082ISO 13485\u306e\u8a8d\u8a3c\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\r\n\r\n

\r\n \r\n \"\"\r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n\r\n
\r\n
\r\n \r\n \"about-img\"\r\n \r\n \r\n \r\n \"shape\"\r\n \r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n
\r\n
<\/div>\r\n <\/div>[vc_empty_space height=”20″][vc_column_text css=”.vc_custom_1660528980228{margin-right: 100px !important;margin-left: 100px !important;}”]<\/p>\n

ISO13485\u306e\u57fa\u790e\u77e5\u8b58<\/h2>\n

ISO13485\u306f\u533b\u7642\u6a5f\u5668\u306b\u8d77\u56e0\u3059\u308b\u4e8b\u6545\u306e\u30ea\u30b9\u30af\u4f4e\u6e1b\u3068\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u5411\u4e0a\u3092\u76ee\u7684\u306b\u4f5c\u3089\u308c\u307e\u3057\u305f\u3002<\/p>\n

\u4e0b\u8a18\u306fISO13485\u304c\u53d6\u308a\u6271\u3046\u9805\u76ee\u306e\u4e00\u4f8b\u3067\u3059\u3002<\/p>\n

    \n
  • \u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u8a55\u4fa1\u3068\u8a2d\u8a08<\/li>\n
  • \u6a5f\u5668\u306e\u6545\u969c\u89e3\u6790<\/li>\n
  • \u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0<\/li>\n<\/ul>\n

    ISO 13485\u306e\u5b9f\u7528\u7684\u306a\u610f\u7fa9<\/h2>\n

    \u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u8cea\u306e\u9ad8\u3044\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u4f9b\u7d66\u3092\u884c\u3046\u5834\u5408\u3001ISO 13485\u306e\u8981\u6c42\u4e8b\u9805\u306b\u5bfe\u3059\u308b\u7406\u89e3\u306f\u5fc5\u9808\u3067\u3059\u3002\u307e\u305f\u3001\u5f93\u696d\u54e1\u3082\u898f\u683c\u306e\u5b9a\u3081\u308b\u8981\u4ef6\u306b\u7cbe\u901a\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n

    ISO13485\u3067\u306f\u88fd\u54c1\u306e\u8a2d\u8a08\u3084\u88fd\u9020\u3001\u6587\u66f8\u5316\u3001\u5de5\u7a0b\u7ba1\u7406\u3001\u305d\u3057\u3066\u4fdd\u8a3c\u306b\u95a2\u308f\u308b\u5177\u4f53\u7684\u306a\u8981\u6c42\u4e8b\u9805\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u898f\u683c\u306b\u6e96\u62e0\u3059\u308b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81ea\u793e\u88fd\u54c1\u306e\u54c1\u8cea\u304c\u512a\u308c\u305f\u3082\u306e\u3067\u3042\u308b\u3068\u78ba\u8a3c\u3092\u6301\u3063\u3066\u4e3b\u5f35\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3067\u3059\u3002<\/p>\n

    \u4e16\u754c\u4e2d\u3067\u4f7f\u308f\u308c\u308b\u306e\u533b\u7642\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u4fe1\u983c\u6027\u306e\u57fa\u6e96\u3068\u306a\u308b\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u6a5f\u80fd\u3082\u679c\u305f\u3059ISO 13485\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u62c5\u3063\u3066\u3044\u308b\u306e\u3067\u3059\u3002<\/p>\n

    ISO13485\u306f\u79c1\u305f\u3061\u306b\u3069\u306e\u3088\u3046\u306a\u95a2\u4fc2\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/h2>\n

    ISO 13485\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u8a2d\u8a08\u306b\u5bfe\u3059\u308b\u4eba\u3005\u306e\u4e0d\u5b89\u3092\u89e3\u6d88\u3059\u308b\u305f\u3081\u306b\u4f5c\u3089\u308c\u307e\u3057\u305f\u3002<\/p>\n

    \u4f01\u696d\u304cISO 13485\u306b\u6e96\u62e0\u3059\u308b\u305f\u3081\u306b\u306f\u69d8\u3005\u306a\u8981\u4ef6\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u8981\u4ef6\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u88fd\u9020\u3092\u884c\u3046\u624b\u9806\u304c\u660e\u78ba\u3067\u3042\u308b\u3053\u3068\u3001\u88fd\u54c1\u304c\u5b89\u5168\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3001\u305d\u3057\u3066\u512a\u308c\u305f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u5099\u3048\u3066\u3044\u308b\u3053\u3068\u306a\u3069\u3082\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n

    ISO 13485\u304c\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u3078\u4e0e\u3048\u308b\u5f71\u97ff\u306b\u3064\u3044\u3066\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u91cd\u8981\u3067\u3059\u3002\u3082\u3057\u3042\u306a\u305f\u306e\u4f1a\u793e\u304c\u5fc5\u8981\u3068\u3055\u308c\u308b\u57fa\u6e96\u3092\u3059\u3079\u3066\u6e80\u305f\u3057\u3066\u3044\u308b\u306e\u3067\u3042\u308c\u3070\u3001\u53d6\u308a\u6271\u3046\u88fd\u54c1\u306f\u65e2\u306bISO 13485\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u305d\u3046\u3067\u306a\u3044\u5834\u5408\u3001\u88fd\u54c1\u306b\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u304c\u8a8d\u3081\u3089\u308c\u305f\u3068\u3057\u3066\u3082\u9867\u5ba2\u304c\u671f\u5f85\u3059\u308b\u57fa\u6e96\u306b\u9054\u3057\u3066\u3044\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

    \u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u643a\u308f\u308b\u4f01\u696d\u3067\u3042\u308b\u306a\u3089\u3070\u3001ISO 13485\u306b\u3064\u3044\u3066\u77e5\u308a\u3001\u3053\u306e\u898f\u683c\u304c\u30d3\u30b8\u30cd\u30b9\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002ISO13485\u306e\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u5f53\u793e\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u3054\u89a7\u3044\u305f\u3060\u304f\u304b\u3001\u307e\u305f\u306f\u5f53\u793e\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/p>\n

    ISO13485: \u533b\u7642\u6a5f\u5668\u8a8d\u8a3c\u53d6\u5f97\u3092\u76ee\u6307\u3059\u6642\u306e\u5fc3\u5f97<\/h2>\n

    \u533b\u7642\u6a5f\u5668\u8a8d\u8a3c\u306e\u53d6\u5f97\u3092\u76ee\u6307\u3059\u5834\u5408\u3001\u3044\u304f\u3064\u304b\u7559\u610f\u3059\u308b\u3079\u304d\u70b9\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

      \n
    • \u307e\u305a\u7b2c\u4e00\u306b\u3001ISO\u898f\u683c\u306f\u3068\u3066\u3082\u91cd\u8981\u3060\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002ISO\u4f53\u5236\u4e0b\u3067\u306f\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u30c6\u30b9\u30c8\u3059\u308b\u4f53\u5236\u304c\u63d0\u4f9b\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u5fc5\u8981\u306a\u30c6\u30b9\u30c8\u65b9\u6cd5\u306b\u3064\u3044\u3066\u306f\u660e\u78ba\u306b\u793a\u3055\u308c\u3066\u304a\u308a\u3001\u88fd\u9020\u5de5\u7a0b\u306b\u304a\u3044\u3066\u3057\u304b\u308b\u3079\u304d\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\u3092\u53d7\u3051\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u304c\u78ba\u8a8d\u3055\u308c\u307e\u3059\u3002<\/li>\n
    • \u7b2c\u4e8c\u306b\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u7d44\u7e54\u304b\u3089\u8a8d\u8a3c\u3092\u53d7\u3051\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u3042\u306a\u305f\u306e\u88fd\u54c1\u304c\u8a8d\u5b9a\u6a5f\u95a2\u306e\u5b9a\u3081\u308b\u57fa\u6e96\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u6b63\u5f0f\u306b\u8a3c\u660e\u3059\u308b\u305f\u3081\u6ce8\u610f\u3059\u3079\u304d\u30dd\u30a4\u30f3\u30c8\u3068\u306a\u308a\u307e\u3059\u3002<\/li>\n
    • \u6700\u5f8c\u306b\u3001\u95a2\u9023\u3059\u308b\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u5341\u5206\u306b\u7406\u89e3\u3057\u3066\u304a\u304f\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u8907\u96d1\u306a\u898f\u5236\u6761\u4ef6\u3092\u304f\u3050\u308a\u306c\u3051\u8a8d\u8a3c\u53d6\u5f97\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u77e5\u8b58\u3067\u3059\u3002<\/li>\n<\/ul>\n

      ISO13485\u306e\u898f\u5236\u30d7\u30ed\u30bb\u30b9<\/h2>\n

      ISO13485\u306f\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u767b\u9332\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u30eb\u30fc\u30eb\u3092\u5b9a\u3081\u305f\u56fd\u969b\u898f\u683c\u3067\u3059\u3002<\/p>\n

      \u533b\u7642\u6a5f\u5668\u3092\u6b27\u5dde\u9023\u5408\u3084\u305d\u306e\u4ed6\u306e\u5730\u57df\u3067\u8ca9\u58f2\u3092\u884c\u3046\u5834\u5408\u306fISO 13485\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5f53\u898f\u683c\u306f\u8981\u6c42\u4e8b\u9805\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3001\u305d\u3057\u3066\u63a8\u5968\u4e8b\u9805\u306e3\u90e8\u69cb\u6210\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n

      \u8981\u6c42\u4e8b\u9805\u306e\u90e8\u3067\u306f\u88fd\u54c1\u306e\u30bf\u30a4\u30d7\u3084\u6027\u80fd\u7279\u6027\u306a\u3069\u3001\u88fd\u54c1\u304a\u3088\u3073\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306b\u5bfe\u3059\u308b\u8981\u6c42\u4e8b\u9805\u3092\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u90e8\u3067\u306f\u88fd\u54c1\u306e\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u5177\u4f53\u7684\u306a\u65b9\u6cd5\u3001\u63a8\u5968\u4e8b\u9805\u306e\u90e8\u3067\u306f\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u30fb\u4f7f\u7528\u306b\u6700\u9069\u306a\u74b0\u5883\u3092\u6574\u5099\u3059\u308b\u305f\u3081\u306b\u63a8\u5968\u3055\u308c\u308b\u8981\u4ef6\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n

      ISO13485\u306f\u6642\u3068\u3057\u3066\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u8ca0\u62c5\u306b\u306a\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u3053\u306e\u898f\u683c\u306b\u6b63\u3057\u304f\u5f93\u3046\u3053\u3068\u3067\u5b89\u5168\u6027\u3084\u898f\u5236\u306e\u9762\u3067\u8d77\u3053\u308a\u3046\u308b\u554f\u984c\u3092\u4e8b\u524d\u306b\u56de\u907f\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3067\u3059\u3002<\/p>\n

      ISO 13485\u306e\u30e1\u30ea\u30c3\u30c8<\/h2>\n

      ISO13485\u898f\u683c\u306e\u30e1\u30ea\u30c3\u30c8\u306e1\u3064\u306f\u3001\u7d71\u4e00\u3055\u308c\u305f\u65b9\u6cd5\u3067\u533b\u7642\u6280\u8853\u306e\u8a66\u9a13\u30fb\u8a55\u4fa1\u304c\u3067\u304d\u308b\u3068\u3044\u3046\u70b9\u3068\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u3063\u3066\u6700\u9069\u306a\u6cbb\u7642\u6cd5\u306e\u7279\u5b9a\u3084\u6b63\u78ba\u306a\u8a3a\u65ad\u304c\u3088\u308a\u7c21\u5358\u306b\u306a\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u533b\u7642\u6280\u8853\u306b\u304b\u304b\u308b\u30b3\u30b9\u30c8\u524a\u6e1b\u306b\u3082\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/p>\n

      ISO\u306f\u4e16\u754c\u7684\u306a\u6a19\u6e96\u5316\u56e3\u4f53\u3067\u3042\u308a\u3001\u533b\u7642\u6280\u8853\u306b\u304a\u3044\u3066\u4e16\u754c\u5358\u4e00\u306e\u6280\u8853\u6e2c\u5b9a\u3092\u884c\u3046\u4f53\u5236\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u7570\u306a\u308b\u4f01\u696d\u306b\u3088\u3063\u3066\u88fd\u9020\u3055\u308c\u305f\u88fd\u54c1\u304c\u5171\u540c\u3067\u4f7f\u7528\u3055\u308c\u308b\u3088\u3046\u306a\u5834\u5408\u3082\u5f93\u6765\u901a\u308a\u306e\u6a5f\u80fd\u304c\u4fdd\u8a3c\u3055\u308c\u308b\u306e\u3067\u3059\u3002<\/p>\n

      ISO 13485\u304b\u3089\u5f97\u3089\u308c\u308b\u3082\u3046\u4e00\u3064\u306e\u5229\u70b9\u306f\u3001\u533b\u7642\u6280\u8853\u306b\u3082\u305f\u3089\u3055\u308c\u308b\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u9032\u51fa\u306e\u6a5f\u4f1a\u3067\u3059\u3002ISO\u898f\u683c\u306f\u69d8\u3005\u306a\u56fd\u306e\u533b\u7642\u6280\u8853\u304c\u5236\u7d04\u306a\u3057\u306b\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u3078\u51fa\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3057\u3066\u304f\u308c\u308b\u305f\u3081\u3001\u533b\u7642\u6280\u8853\u7523\u696d\u306b\u643a\u308f\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u65b0\u305f\u306a\u30d3\u30b8\u30cd\u30b9\u30c1\u30e3\u30f3\u30b9\u3092\u958b\u304f\u5951\u6a5f\u3068\u306a\u308a\u5f97\u307e\u3059\u3002<\/p>\n

      \u3064\u307e\u308a\u3001ISO13485\u306f\u60a3\u8005\u3068\u533b\u7642\u6280\u8853\u30e1\u30fc\u30ab\u30fc\u306e\u53cc\u65b9\u306b\u69d8\u3005\u306a\u5f62\u3067\u8ca2\u732e\u3059\u308b\u975e\u5e38\u306b\u91cd\u8981\u306a\u6a19\u6e96\u5316\u56e3\u4f53\u3068\u8a00\u3048\u308b\u306e\u3067\u3059\u3002<\/p>\n

      ISO 13485\u306e\u8981\u6c42\u4e8b\u9805<\/h2>\n

      ISO13485\u306b\u3088\u308b\u3068\u3001\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u8a66\u9a13\u524d\u306b\u3042\u3089\u304b\u3058\u3081\u5b9a\u7fa9\u3055\u308c\u305f\u8981\u4ef6\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u6a5f\u95a2\u306b\u3088\u308b\u691c\u67fb\u3092\u6700\u521d\u306b\u53d7\u3051\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u57fa\u6e96\u306f\u3001\u65b0\u898f\u306b\u958b\u767a\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3092\u53ef\u80fd\u306a\u9650\u308a\u78ba\u5b9f\u306a\u3082\u306e\u306b\u3059\u308b\u305f\u3081\u8a2d\u3051\u3089\u308c\u307e\u3057\u305f\u3002<\/p>\n

      ISO13485\u306f\u3001FDA\u3084CE\u30de\u30fc\u30af\u306e\u3088\u3046\u306a\u6cd5\u7684\u306a\u8981\u6c42\u4e8b\u9805\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002ISO 13485\u306f\u5546\u54c1\u5316\u3055\u308c\u308b\u524d\u306e\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u898f\u5236\u306b\u7528\u3044\u308b\u7528\u8a9e\u3084\u624b\u7d9a\u304d\u3001\u624b\u9806\u306a\u3069\u3092\u52a0\u76df\u56fd\u9593\u3067\u5171\u901a\u306e\u5f62\u5f0f\u306b\u6574\u5099\u3059\u308b\u305f\u3081\u306b\u8a2d\u3051\u3089\u308c\u305f\u4efb\u610f\u53d6\u5f97\u306e\u898f\u683c\u3067\u3059\u3002<\/p>\n

      ISO13845 \u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9<\/h2>\n

      ISO\u306f\u3001\u88fd\u54c1\u3084\u30b5\u30fc\u30d3\u30b9\u306e\u4e16\u754c\u306b\u901a\u7528\u3059\u308b\u54c1\u8cea\u57fa\u6e96\u3092\u5236\u5b9a\u3059\u308b\u56fd\u969b\u7684\u306a\u6a19\u6e96\u5316\u56e3\u4f53\u3067\u3059\u3002ISO\u306f\u5927\u304d\u304f2\u3064\u306e\u6a19\u6e96\u5316\u56e3\u4f53\u3092\u904b\u55b6\u3057\u3066\u3044\u307e\u3059\u3002\uff11\u3064\u306f\u533b\u7642\u6a5f\u5668\u3092\u6271\u3046ISO\/IEC 17025\u3001\u3082\u30461\u3064\u306f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u7ba1\u7406\u3059\u308bISO\/TS 16949\u3067\u3059\u3002<\/p>\n

      \u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u660e\u78ba\u306b\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u305d\u306e\u88fd\u54c1\u304c\u9069\u5207\u306a\u54c1\u8cea\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002ISO\u306f\u533b\u7642\u6a5f\u5668\u306e\u300c\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u300d\u3068\u3057\u3066\u56fd\u969b\u7684\u306b\u901a\u7528\u3059\u308b\u54c1\u8cea\u898f\u683c\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u898f\u683c\u3067\u306f\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u8a66\u9a13\u3001\u6587\u66f8\u5316\u3001\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u306b\u95a2\u3059\u308b\u6700\u4f4e\u8981\u4ef6\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n

      \u6b27\u5dde\u3084\u305d\u306e\u4ed6\u306e\u5730\u57df\u3067\u88fd\u54c1\u306e\u8ca9\u58f2\u3092\u691c\u8a0e\u3059\u308b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08MDD\uff09\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002MDD\u306f\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u8a66\u9a13\u3001\u6027\u80fd\u8868\u793a\u3001\u54c1\u8cea\u4fdd\u8a3c\uff0f\u54c1\u8cea\u7ba1\u7406\u624b\u9806\u3001\u305d\u3057\u3066\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306b\u95a2\u3059\u308b\u5177\u4f53\u7684\u306a\u8981\u6c42\u4e8b\u9805\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n

      FDA\u307e\u305f\u306f\u985e\u4f3c\u306e\u898f\u5236\u306b\u3088\u308b\u8a8d\u5b9a\u3092\u53d7\u3051\u308b\u65b9\u6cd5 \u3068ISO13485\u306b\u95a2\u9023\u3059\u308b\u305d\u306e\u4ed6\u306e\u6a5f\u4f1a<\/h2>\n

      ISO\u306f\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u306b\u3064\u3044\u3066\u5b9a\u3081\u3089\u308c\u305f\u56fd\u969b\u898f\u683c\u3067\u3059\u3002ISO13485\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3084\u88fd\u9020\u3001\u8a66\u9a13\u3001\u7ba1\u7406\u3001\u6587\u66f8\u5316\u306e\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u898f\u5247\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n

      ISO13485:2009\u306fISO 13485\u306e\u6700\u65b0\u7248\u3067\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3044\u3066\u5168\u3066\u306e\u5074\u9762\u306b\u5bfe\u5fdc\u3059\u308b\u7dcf\u5408\u7684\u306a\u8981\u4ef6\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n

      FDA\u3042\u308b\u3044\u306f\u540c\u69d8\u306e\u898f\u5236\u306b\u3088\u308b\u8a8d\u8a3c\u3092\u53d7\u3051\u308b\u306b\u306f\u307e\u305aISO13485\u306b\u3064\u3044\u3066\u5b66\u3073\u3001\u3042\u306a\u305f\u304c\u6271\u3046\u7279\u5b9a\u306e\u7a2e\u985e\u306e\u533b\u7642\u6a5f\u5668\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u304b\u3092\u77e5\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8a8d\u8a3c\u53d6\u5f97\u306b\u5fc5\u8981\u306a\u8981\u4ef6\u3068\u624b\u9806\u3092\u7406\u89e3\u3059\u308c\u3070\u3001FDA\u3084CE\u30de\u30fc\u30af\u306a\u3069\u305d\u306e\u4ed6\u306e\u7d44\u7e54\u304c\u63d0\u4f9b\u3059\u308b\u8a8d\u8a3c\u306e\u53d6\u5f97\u7533\u8acb\u306b\u3082\u7740\u624b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n

      ISO13485\u8a8d\u8a3c\u306e\u53d6\u5f97\u306b\u3088\u308a\u3001\u65e2\u306b\u8a8d\u8a3c\u53d6\u5f97\u304c\u6e08\u3093\u3067\u3044\u308b\u4f01\u696d\u3068\u306e\u5171\u540c\u4e8b\u696d\u3084\u5927\u624b\u88fd\u85ac\u4f1a\u793e\u304b\u3089\u306e\u5951\u7d04\u7372\u5f97\u306a\u3069\u3001\u65b0\u305f\u306a\u30d3\u30b8\u30cd\u30b9\u306e\u53ef\u80fd\u6027\u304c\u958b\u304b\u308c\u307e\u3059\u3002<\/p>\n

      ISO13485\u306e\u7406\u89e3\u3092\u6df1\u3081\u308b\u3053\u3068\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u8a8d\u5b9a\u3084\u898f\u5236\u3092\u53d7\u3051\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u5e02\u5834\u3078\u306e\u4e8b\u696d\u62e1\u5927\u3092\u76ee\u6307\u3059\u306e\u3067\u3042\u308c\u3070ISO 13485\u306e\u77e5\u8b58\u306f\u6b20\u304b\u305b\u307e\u305b\u3093\u3002ISO 13485 Initiative \u306f\u5e02\u8ca9\u524d\u306e\u533b\u7642\u6a5f\u5668\u306b\u304a\u3044\u3066\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u7ba1\u7406\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306b\u4f5c\u3089\u308c\u305f\u4e16\u754c\u7684\u306a\u30d7\u30ed\u30b0\u30e9\u30e0\u3067\u3059\u3002<\/p>\n

      \u3053\u306e\u8a8d\u8a3c\u306e\u30d7\u30ed\u30bb\u30b9\u3068\u57fa\u6e96\u306f\u3001\u56fd\u969b\u7684\u306a\u30ec\u30d9\u30eb\u3067\u3042\u308a\u4ed8\u968f\u3059\u308b\u8981\u6c42\u4e8b\u9805\u304c\u3042\u308b\u3068\u3044\u3046\u70b9\u3067FDA\u3084CE\u30de\u30fc\u30af\u3068\u3044\u3063\u305f\u305d\u306e\u4ed6\u306e\u898f\u5236\u6a5f\u95a2\u306e\u3082\u306e\u3068\u4f3c\u3066\u3044\u307e\u3059\u3002ISO\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u306b\u643a\u308f\u308b\u4eba\u3005\u304cISO13485\u306b\u3064\u3044\u3066\u5b66\u3073\u3001\u5168\u5de5\u7a0b\u3092\u901a\u3058\u3066\u4e8b\u696d\u3092\u7ba1\u7406\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002<\/p>\n

      \u8003\u5bdf<\/strong><\/h2>\n

      ISO13485\u898f\u683c\u306f\u6700\u3082\u91cd\u8981\u306a\u533b\u7642\u6a5f\u5668\u898f\u683c\u306e1\u3064\u3067\u3042\u308a\u3001\u591a\u304f\u306e\u6a5f\u5668\u304c\u5e02\u5834\u3067\u627f\u8a8d\u3055\u308c\u308b\u305f\u3081\u306b\u5fc5\u8981\u4e0d\u53ef\u6b20\u306a\u5b58\u5728\u3067\u3059\u3002<\/p>\n

      ISO 13485\u306b\u6e96\u62e0\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u6709\u52b9\u3067\u3042\u308bISO 13485\u8a3c\u660e\u66f8\u3092\u53d6\u5f97\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8a3c\u660e\u66f8\u306e\u53d6\u5f97\u306b\u3088\u3063\u3066\u3001\u88fd\u54c1\u304c\u5b9a\u3081\u3089\u308c\u305f\u898f\u683c\u306b\u5f93\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3067\u304d\u307e\u3059\u3002<\/p>\n

      ISO 13485\u3078\u306e\u6e96\u62e0\u3092\u304a\u8003\u3048\u306e\u5834\u5408\u3001\u305c\u3072\u5f53\u793e\u306b\u304a\u4efb\u305b\u304f\u3060\u3055\u3044\u3002\u5f53\u793e\u3067\u306f\u3001\u898f\u683c\u304c\u6c42\u3081\u308b\u57fa\u6e96\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u8a8d\u8a3c\u53d6\u5f97\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u898f\u683c\u306e\u8981\u6c42\u4e8b\u9805\u5bfe\u5fdc\u3092\u898b\u636e\u3048\u305f\u30aa\u30fc\u30c0\u30fc\u30e1\u30a4\u30c9\u306e\u6307\u5c0e\u3082\u884c\u3063\u3066\u304a\u308a\u307e\u3059\u3002[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section el_class=”team-area uk-team uk-section”][vc_row][vc_column]\r\n

      \r\n <\/span>\r\n

      ISO13485: \u3088\u304f\u3042\u308b\u3054\u8cea\u554f (FAQ)<\/h2>\r\n
      <\/div>\r\n <\/div>[vc_tta_accordion][vc_tta_section title=”ISO\u3068\u306f\uff1f” tab_id=”1659536326614-c459721e-5291″][vc_column_text]ISO\u306f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u304a\u3051\u308b\u56fd\u969b\u7684\u306a\u6a19\u6e96\u898f\u683c\u3067\u3059\u3002\u88fd\u54c1\u306e\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u6587\u66f8\u5316\u3001\u54c1\u8cea\u306e\u8a66\u9a13\u306e\u3059\u3079\u3066\u306e\u9805\u76ee\u306b\u304a\u3044\u3066\u56fd\u969b\u7684\u306a\u57fa\u6e96\u304c\u8a2d\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”ISO13485\u306f\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u78ba\u4fdd\u306b\u304a\u3044\u3066\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3063\u3066\u3044\u307e\u3059\u304b\uff1f” tab_id=”1659536326633-d21a3059-8a50″][vc_column_text]ISO13485\u306f\u533b\u7642\u6a5f\u5668\u304c\u6b63\u3057\u3044\u624b\u9806\u3067\u88fd\u9020\u3055\u308c\u3001\u307e\u305f\u5fc5\u8981\u3068\u3055\u308c\u308b\u5b89\u5168\u57fa\u6e96\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u652f\u63f4\u3092\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u304a\u3088\u3073\u8a66\u9a13\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u63d0\u4f9b\u3082\u884c\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u60a3\u8005\u306e\u671f\u5f85\u306b\u5fdc\u3048\u308b\u8cea\u306e\u9ad8\u3044\u88fd\u54c1\u63d0\u4f9b\u304c\u78ba\u7387\u3055\u308c\u308b\u306e\u3067\u3059\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u306bISO13485\u898f\u683c\u3092\u5229\u7528\u3059\u308b\u30e1\u30ea\u30c3\u30c8\u306f\u4f55\u3067\u3059\u304b\uff1f” tab_id=”1659536817315-e17d9fb3-fd5f”][vc_column_text]\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u306b\u304a\u3051\u308bISO13485\u898f\u683c\u306e\u5229\u7528\u306b\u306f\u69d8\u3005\u306a\u30e1\u30ea\u30c3\u30c8\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u54c1\u8cea\u7ba1\u7406\u304c\u5411\u4e0a\u3059\u308b\u3053\u3068\u3067\u30b3\u30b9\u30c8\u524a\u6e1b\u306b\u3064\u306a\u304c\u308b\u52b9\u679c\u304c\u3042\u3052\u3089\u308c\u307e\u3059\u3002<\/p>\n

      \u52a0\u3048\u3066\u3001\u88fd\u54c1\u751f\u7523\u30d1\u30bf\u30fc\u30f3\u306e\u4e00\u8cab\u6027\u3092\u9ad8\u3081\u308b\u3053\u3068\u3067\u4e88\u671f\u305b\u306c\u30a2\u30af\u30b7\u30c7\u30f3\u30c8\u306e\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3064\u307e\u308a\u3001ISO 13485\u898f\u683c\u306e\u5229\u7528\u306f\u4f01\u696d\u306e\u8cbb\u7528\u3084\u6642\u9593\u3092\u7bc0\u7d04\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u60a3\u8005\u306b\u3088\u308a\u826f\u3044\u30b1\u30a2\u3092\u5c4a\u3051\u308b\u3053\u3068\u306b\u8ca2\u732e\u3059\u308b\u306e\u3067\u3059\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”ISO13485\u306e\u898f\u5b9a\u3067\u533b\u7642\u6a5f\u5668\u306b\u5206\u985e\u3055\u308c\u308b\u3082\u306e\u306f\u4f55\u3067\u3059\u304b\uff1f” tab_id=”1659537094245-9a0f676c-dd46″][vc_column_text]\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u533b\u7642\u5668\u5177\u3001\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u3068\u3044\u3063\u305f\u3082\u306e\u304c\u533b\u7642\u6a5f\u5668\u306b\u8a72\u5f53\u3057\u307e\u3059\u3002\u4e00\u822c\u7684\u306b\u3001\u533b\u5e2b\u304c\u69d8\u3005\u306a\u60a3\u8005\u306e\u75c5\u6c17\u3092\u8a3a\u65ad\u3057\u3001\u7d4c\u904e\u89b3\u5bdf\u3084\u6cbb\u7642\u3092\u884c\u3046\u969b\u306b\u88dc\u52a9\u306e\u5f79\u5272\u3092\u3059\u308b\u3082\u306e\u5168\u3066\u304c\u542b\u307e\u308c\u307e\u3059\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”ISO 13485\u306f\u306a\u305c\u5fc5\u8981\u306a\u306e\u3067\u3059\u304b\u3001\u307e\u305f\u8ab0\u304c\u5fc5\u8981\u306a\u306e\u3067\u3059\u304b\uff1f” tab_id=”1659537098892-bf3103ab-96ee”][vc_column_text]ISO13485\u306f\u3001\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u95a2\u9023\u30b5\u30fc\u30d3\u30b9\u306e\u958b\u767a\u3001\u88fd\u9020\u3001\u6d41\u901a\u3001\u305d\u3057\u3066\u54c1\u8cea\u7dad\u6301\u306b\u5f93\u4e8b\u3059\u308b\u4f01\u696d\u306b\u5411\u3051\u3066\u4f5c\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u8a8d\u8a3c\u6a5f\u95a2\u306e\u3088\u3046\u306a\u4f01\u696d\u5185\u5916\u306e\u7d44\u7e54\u306b\u304a\u3044\u3066\u3082\u3001\u5f53\u898f\u683c\u3092\u76e3\u67fb\u306b\u5f79\u7acb\u3066\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n

      ISO 13485\u306f\u3001\u4ed6\u306eISO\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u898f\u683c\u3068\u540c\u69d8\u3001\u4f01\u696d\u306b\u5bfe\u3059\u308b\u63a1\u7528\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u305b\u3093\u3002\u8a8d\u8a3c\u53d6\u5f97\u306b\u3088\u308b\u30e1\u30ea\u30c3\u30c8\u3092\u53d7\u3051\u308b\u304b\u53d7\u3051\u306a\u3044\u304b\u306e\u5224\u65ad\u306f\u4efb\u610f\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u5f53\u898f\u683c\u304c\u5b9a\u3081\u308b\u898f\u7bc4\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u306b\u3064\u3044\u3066\u7b2c\u4e09\u8005\u6a5f\u95a2\u306b\u3088\u308b\u88cf\u4ed8\u3051\u304c\u53d6\u308c\u308b\u5834\u5408\u306f\u3001\u898f\u5236\u5f53\u5c40\u306b\u5bfe\u3057\u3066\u4f1a\u793e\u304c\u884c\u3046\u54c1\u8cea\u7ba1\u7406\u306e\u53d6\u308a\u7d44\u307f\u3092\u8a3c\u660e\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u306a\u304a\u3001ISO\u306f\u8a8d\u8a3c\u6a5f\u95a2\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”ISO 13485\u306f\u306a\u305c\u66f4\u65b0\u3055\u308c\u305f\u306e\u3067\u3059\u304b\uff1f” tab_id=”1660528784836-3865f85e-2c08″][vc_column_text]ISO13485\u898f\u683c\u306f\u3001\u696d\u754c\u306e\u6700\u65b0\u72b6\u6cc1\u306b\u5373\u3057\u3066\u3044\u308b\u304b\u3001\u66f4\u65b0\u304c\u5fc5\u8981\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306b5\u5e74\u3054\u3068\u306e\u8a55\u4fa1\u304c\u5b9f\u65bd\u3055\u308c\u307e\u3059\u3002ISO 13485:2016\u3067\u306f\u3001\u6700\u65b0\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u6280\u8853\u3084\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u3001\u898f\u5236\u8981\u4ef6\u3001\u671f\u5f85\u5024\u306b\u304a\u3051\u308b\u5909\u5316\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u5185\u5bb9\u304c\u88dc\u8db3\u3055\u308c\u307e\u3057\u305f\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”\u4e3b\u306a\u6539\u5584\u70b9\u306f\u4f55\u3067\u3059\u304b\uff1f” tab_id=”1660528848054-a087bdb0-16e0″][vc_column_text]\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u4f01\u696d\u304c\u3088\u308a\u591a\u304f\u306e\u30eb\u30fc\u30eb\u306b\u5f93\u3046\u3053\u3068\u3092\u6c42\u3081\u3089\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u73fe\u72b6\u3092\u53cd\u6620\u3057\u3001\u6700\u65b0\u7248\u3067\u306f\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3068\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u610f\u601d\u6c7a\u5b9a\u306b\u3055\u3089\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”ISO13485\u306e\u30ed\u30b4\u3092\u4f7f\u3063\u3066\u3082\u3044\u3044\u3067\u3059\u304b\uff1f” tab_id=”1660528868531-f5787fa9-2e75″][vc_column_text]ISO13485\u306e\u30ed\u30b4\u306f\u5546\u6a19\u306e\u305f\u3081\u3001ISO\u304b\u3089\u8a31\u53ef\u3055\u308c\u305f\u4eba\u3057\u304b\u4f7f\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u305b\u3093\u3002<\/p>\n

      \u30ed\u30b4\u3092\u8ca9\u4fc3\u7269\u306b\u4f7f\u7528\u3059\u308b\u5834\u5408\u306f\u8a8d\u5b9a\u8a3c\u3092\u53d6\u5f97\u3057\u305f\u56e3\u4f53\u3078\u9023\u7d61\u3057\u3066\u304f\u3060\u3055\u3044\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”ISO13485\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u306a\u3044\u5834\u5408\u306f\uff1f” tab_id=”1660528910807-35568ad5-e33a”][vc_column_text]\u533b\u7642\u6a5f\u5668\u306fFDA\u306e\u898f\u5236\u4e0b\u306b\u3042\u308a\u3001\u7c73\u56fd\u3067\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306b\u306f\u4e00\u5b9a\u306e\u5b89\u5168\u6027\u3068\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002ISO13485\u306f\u305d\u306e\u57fa\u6e96\u306b\u542b\u307e\u308c\u308b\u6761\u4ef6\u306e\u4e00\u3064\u3067\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u3092\u88fd\u9020\u3059\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u5fc5\u8981\u4e0d\u53ef\u6b20\u306a\u3082\u306e\u3067\u3059\u3002<\/p>\n

      \u73fe\u5728\u3001\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u3084\u4f9b\u7d66\u306b\u5b9f\u969b\u306b\u643a\u308f\u3063\u3066\u3044\u306a\u304f\u3066\u3082\u5fc3\u914d\u306f\u3044\u308a\u307e\u305b\u3093\u3002ISO 13485\u306b\u3064\u3044\u3066\u5b66\u3073\u3001\u5fc5\u8981\u306a\u5b89\u5168\u5bfe\u7b56\u3068\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u5bfe\u7b56\u3092\u8b1b\u3058\u308b\u3053\u3068\u3067\u30d3\u30b8\u30cd\u30b9\u306e\u652f\u63f4\u306b\u3064\u306a\u3052\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][\/vc_column][\/vc_row][\/vc_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

      [vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][vc_empty_space height=”20″][vc_column_text css=”.vc_custom_1660528980228{margin-right: 100px !important;margin-left: 100px !important;}”] ISO13485\u306e\u57fa\u790e\u77e5\u8b58 ISO13485\u306f\u533b\u7642\u6a5f\u5668\u306b\u8d77\u56e0\u3059\u308b\u4e8b\u6545\u306e\u30ea\u30b9\u30af\u4f4e\u6e1b\u3068\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u5411\u4e0a\u3092\u76ee\u7684\u306b\u4f5c\u3089\u308c\u307e\u3057\u305f\u3002 \u4e0b\u8a18\u306fISO13485\u304c\u53d6\u308a\u6271\u3046\u9805\u76ee\u306e\u4e00\u4f8b\u3067\u3059\u3002 \u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u8a55\u4fa1\u3068\u8a2d\u8a08 \u6a5f\u5668\u306e\u6545\u969c\u89e3\u6790 \u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0 ISO 13485\u306e\u5b9f\u7528\u7684\u306a\u610f\u7fa9 \u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u8cea\u306e\u9ad8\u3044\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u4f9b\u7d66\u3092\u884c\u3046\u5834\u5408\u3001ISO 13485\u306e\u8981\u6c42\u4e8b\u9805\u306b\u5bfe\u3059\u308b\u7406\u89e3\u306f\u5fc5\u9808\u3067\u3059\u3002\u307e\u305f\u3001\u5f93\u696d\u54e1\u3082\u898f\u683c\u306e\u5b9a\u3081\u308b\u8981\u4ef6\u306b\u7cbe\u901a\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002 ISO13485\u3067\u306f\u88fd\u54c1\u306e\u8a2d\u8a08\u3084\u88fd\u9020\u3001\u6587\u66f8\u5316\u3001\u5de5\u7a0b\u7ba1\u7406\u3001\u305d\u3057\u3066\u4fdd\u8a3c\u306b\u95a2\u308f\u308b\u5177\u4f53\u7684\u306a\u8981\u6c42\u4e8b\u9805\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u898f\u683c\u306b\u6e96\u62e0\u3059\u308b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81ea\u793e\u88fd\u54c1\u306e\u54c1\u8cea\u304c\u512a\u308c\u305f\u3082\u306e\u3067\u3042\u308b\u3068\u78ba\u8a3c\u3092\u6301\u3063\u3066\u4e3b\u5f35\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3067\u3059\u3002 \u4e16\u754c\u4e2d\u3067\u4f7f\u308f\u308c\u308b\u306e\u533b\u7642\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u4fe1\u983c\u6027\u306e\u57fa\u6e96\u3068\u306a\u308b\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u6a5f\u80fd\u3082\u679c\u305f\u3059ISO 13485\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u62c5\u3063\u3066\u3044\u308b\u306e\u3067\u3059\u3002 ISO13485\u306f\u79c1\u305f\u3061\u306b\u3069\u306e\u3088\u3046\u306a\u95a2\u4fc2\u304c\u3042\u308a\u307e\u3059\u304b\uff1f ISO 13485\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u8a2d\u8a08\u306b\u5bfe\u3059\u308b\u4eba\u3005\u306e\u4e0d\u5b89\u3092\u89e3\u6d88\u3059\u308b\u305f\u3081\u306b\u4f5c\u3089\u308c\u307e\u3057\u305f\u3002 \u4f01\u696d\u304cISO 13485\u306b\u6e96\u62e0\u3059\u308b\u305f\u3081\u306b\u306f\u69d8\u3005\u306a\u8981\u4ef6\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u8981\u4ef6\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u88fd\u9020\u3092\u884c\u3046\u624b\u9806\u304c\u660e\u78ba\u3067\u3042\u308b\u3053\u3068\u3001\u88fd\u54c1\u304c\u5b89\u5168\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3001\u305d\u3057\u3066\u512a\u308c\u305f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u5099\u3048\u3066\u3044\u308b\u3053\u3068\u306a\u3069\u3082\u542b\u307e\u308c\u307e\u3059\u3002 ISO 13485\u304c\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u3078\u4e0e\u3048\u308b\u5f71\u97ff\u306b\u3064\u3044\u3066\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u91cd\u8981\u3067\u3059\u3002\u3082\u3057\u3042\u306a\u305f\u306e\u4f1a\u793e\u304c\u5fc5\u8981\u3068\u3055\u308c\u308b\u57fa\u6e96\u3092\u3059\u3079\u3066\u6e80\u305f\u3057\u3066\u3044\u308b\u306e\u3067\u3042\u308c\u3070\u3001\u53d6\u308a\u6271\u3046\u88fd\u54c1\u306f\u65e2\u306bISO 13485\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u305d\u3046\u3067\u306a\u3044\u5834\u5408\u3001\u88fd\u54c1\u306b\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u304c\u8a8d\u3081\u3089\u308c\u305f\u3068\u3057\u3066\u3082\u9867\u5ba2\u304c\u671f\u5f85\u3059\u308b\u57fa\u6e96\u306b\u9054\u3057\u3066\u3044\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002 \u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u643a\u308f\u308b\u4f01\u696d\u3067\u3042\u308b\u306a\u3089\u3070\u3001ISO 13485\u306b\u3064\u3044\u3066\u77e5\u308a\u3001\u3053\u306e\u898f\u683c\u304c\u30d3\u30b8\u30cd\u30b9\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002ISO13485\u306e\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u5f53\u793e\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u3054\u89a7\u3044\u305f\u3060\u304f\u304b\u3001\u307e\u305f\u306f\u5f53\u793e\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002 ISO13485: \u533b\u7642\u6a5f\u5668\u8a8d\u8a3c\u53d6\u5f97\u3092\u76ee\u6307\u3059\u6642\u306e\u5fc3\u5f97 \u533b\u7642\u6a5f\u5668\u8a8d\u8a3c\u306e\u53d6\u5f97\u3092\u76ee\u6307\u3059\u5834\u5408\u3001\u3044\u304f\u3064\u304b\u7559\u610f\u3059\u308b\u3079\u304d\u70b9\u304c\u3042\u308a\u307e\u3059\u3002 \u307e\u305a\u7b2c\u4e00\u306b\u3001ISO\u898f\u683c\u306f\u3068\u3066\u3082\u91cd\u8981\u3060\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002ISO\u4f53\u5236\u4e0b\u3067\u306f\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u30c6\u30b9\u30c8\u3059\u308b\u4f53\u5236\u304c\u63d0\u4f9b\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u5fc5\u8981\u306a\u30c6\u30b9\u30c8\u65b9\u6cd5\u306b\u3064\u3044\u3066\u306f\u660e\u78ba\u306b\u793a\u3055\u308c\u3066\u304a\u308a\u3001\u88fd\u9020\u5de5\u7a0b\u306b\u304a\u3044\u3066\u3057\u304b\u308b\u3079\u304d\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\u3092\u53d7\u3051\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u304c\u78ba\u8a8d\u3055\u308c\u307e\u3059\u3002 \u7b2c\u4e8c\u306b\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u7d44\u7e54\u304b\u3089\u8a8d\u8a3c\u3092\u53d7\u3051\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u3042\u306a\u305f\u306e\u88fd\u54c1\u304c\u8a8d\u5b9a\u6a5f\u95a2\u306e\u5b9a\u3081\u308b\u57fa\u6e96\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u6b63\u5f0f\u306b\u8a3c\u660e\u3059\u308b\u305f\u3081\u6ce8\u610f\u3059\u3079\u304d\u30dd\u30a4\u30f3\u30c8\u3068\u306a\u308a\u307e\u3059\u3002 \u6700\u5f8c\u306b\u3001\u95a2\u9023\u3059\u308b\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u5341\u5206\u306b\u7406\u89e3\u3057\u3066\u304a\u304f\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u8907\u96d1\u306a\u898f\u5236\u6761\u4ef6\u3092\u304f\u3050\u308a\u306c\u3051\u8a8d\u8a3c\u53d6\u5f97\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u77e5\u8b58\u3067\u3059\u3002 ISO13485\u306e\u898f\u5236\u30d7\u30ed\u30bb\u30b9 ISO13485\u306f\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u767b\u9332\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u30eb\u30fc\u30eb\u3092\u5b9a\u3081\u305f\u56fd\u969b\u898f\u683c\u3067\u3059\u3002 \u533b\u7642\u6a5f\u5668\u3092\u6b27\u5dde\u9023\u5408\u3084\u305d\u306e\u4ed6\u306e\u5730\u57df\u3067\u8ca9\u58f2\u3092\u884c\u3046\u5834\u5408\u306fISO 13485\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5f53\u898f\u683c\u306f\u8981\u6c42\u4e8b\u9805\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3001\u305d\u3057\u3066\u63a8\u5968\u4e8b\u9805\u306e3\u90e8\u69cb\u6210\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u8981\u6c42\u4e8b\u9805\u306e\u90e8\u3067\u306f\u88fd\u54c1\u306e\u30bf\u30a4\u30d7\u3084\u6027\u80fd\u7279\u6027\u306a\u3069\u3001\u88fd\u54c1\u304a\u3088\u3073\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306b\u5bfe\u3059\u308b\u8981\u6c42\u4e8b\u9805\u3092\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u90e8\u3067\u306f\u88fd\u54c1\u306e\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u5177\u4f53\u7684\u306a\u65b9\u6cd5\u3001\u63a8\u5968\u4e8b\u9805\u306e\u90e8\u3067\u306f\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u30fb\u4f7f\u7528\u306b\u6700\u9069\u306a\u74b0\u5883\u3092\u6574\u5099\u3059\u308b\u305f\u3081\u306b\u63a8\u5968\u3055\u308c\u308b\u8981\u4ef6\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002 ISO13485\u306f\u6642\u3068\u3057\u3066\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u8ca0\u62c5\u306b\u306a\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u3053\u306e\u898f\u683c\u306b\u6b63\u3057\u304f\u5f93\u3046\u3053\u3068\u3067\u5b89\u5168\u6027\u3084\u898f\u5236\u306e\u9762\u3067\u8d77\u3053\u308a\u3046\u308b\u554f\u984c\u3092\u4e8b\u524d\u306b\u56de\u907f\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3067\u3059\u3002 ISO 13485\u306e\u30e1\u30ea\u30c3\u30c8 ISO13485\u898f\u683c\u306e\u30e1\u30ea\u30c3\u30c8\u306e1\u3064\u306f\u3001\u7d71\u4e00\u3055\u308c\u305f\u65b9\u6cd5\u3067\u533b\u7642\u6280\u8853\u306e\u8a66\u9a13\u30fb\u8a55\u4fa1\u304c\u3067\u304d\u308b\u3068\u3044\u3046\u70b9\u3068\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u3063\u3066\u6700\u9069\u306a\u6cbb\u7642\u6cd5\u306e\u7279\u5b9a\u3084\u6b63\u78ba\u306a\u8a3a\u65ad\u304c\u3088\u308a\u7c21\u5358\u306b\u306a\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u533b\u7642\u6280\u8853\u306b\u304b\u304b\u308b\u30b3\u30b9\u30c8\u524a\u6e1b\u306b\u3082\u3064\u306a\u304c\u308a\u307e\u3059\u3002 ISO\u306f\u4e16\u754c\u7684\u306a\u6a19\u6e96\u5316\u56e3\u4f53\u3067\u3042\u308a\u3001\u533b\u7642\u6280\u8853\u306b\u304a\u3044\u3066\u4e16\u754c\u5358\u4e00\u306e\u6280\u8853\u6e2c\u5b9a\u3092\u884c\u3046\u4f53\u5236\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u7570\u306a\u308b\u4f01\u696d\u306b\u3088\u3063\u3066\u88fd\u9020\u3055\u308c\u305f\u88fd\u54c1\u304c\u5171\u540c\u3067\u4f7f\u7528\u3055\u308c\u308b\u3088\u3046\u306a\u5834\u5408\u3082\u5f93\u6765\u901a\u308a\u306e\u6a5f\u80fd\u304c\u4fdd\u8a3c\u3055\u308c\u308b\u306e\u3067\u3059\u3002 ISO 13485\u304b\u3089\u5f97\u3089\u308c\u308b\u3082\u3046\u4e00\u3064\u306e\u5229\u70b9\u306f\u3001\u533b\u7642\u6280\u8853\u306b\u3082\u305f\u3089\u3055\u308c\u308b\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u9032\u51fa\u306e\u6a5f\u4f1a\u3067\u3059\u3002ISO\u898f\u683c\u306f\u69d8\u3005\u306a\u56fd\u306e\u533b\u7642\u6280\u8853\u304c\u5236\u7d04\u306a\u3057\u306b\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u3078\u51fa\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3057\u3066\u304f\u308c\u308b\u305f\u3081\u3001\u533b\u7642\u6280\u8853\u7523\u696d\u306b\u643a\u308f\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u65b0\u305f\u306a\u30d3\u30b8\u30cd\u30b9\u30c1\u30e3\u30f3\u30b9\u3092\u958b\u304f\u5951\u6a5f\u3068\u306a\u308a\u5f97\u307e\u3059\u3002 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