{"id":3286,"date":"2025-10-15T06:27:38","date_gmt":"2025-10-15T06:27:38","guid":{"rendered":"https:\/\/hanheng.easiwin.com\/?p=3286"},"modified":"2025-04-11T06:38:46","modified_gmt":"2025-04-11T06:38:46","slug":"iso-13485-certification20250804","status":"publish","type":"post","link":"https:\/\/hanheng-medical.com\/ja\/blog\/iso-13485-certification20250804\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306eISO 13485\u8a8d\u5b9a\u3092\u7406\u89e3\u3059\u308b: \u5378\u58f2\u30d0\u30a4\u30e4\u30fc\u304a\u3088\u3073\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u5411\u3051\u30ac\u30a4\u30c9"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"1-introduction-the-critical-role-of-iso-13485-in-medical-device-supply-chains\">1. \u5c0e\u5165: \u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3051\u308bISO 13485\u306e\u91cd\u8981\u306a\u5f79\u5272<\/h2>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u304a\u3088\u3073\u6d41\u901a\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u72b6\u6cc1\u306b\u304a\u3044\u3066\u3001 <strong>\u5bfe\u8c61\u89e3\u5256\u5b66\u306b\u6700\u9069\u5316\u3055\u308c\u305f\u30c1\u30c3\u30d7\u5f62\u72b6\uff08\u4e38\u578b\u3001\u30c6\u30fc\u30d1\u30fc\u578b\u3001\u30d6\u30e9\u30b7\u578b\uff09<\/strong> \u306f\u54c1\u8cea\u4fdd\u8a3c\u3068\u898f\u5236\u9075\u5b88\u306e\u57fa\u76e4\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u5378\u58f2\u30d0\u30a4\u30e4\u30fc\u3001\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u3001\u30d8\u30eb\u30b9\u30b1\u30a2\u8abf\u9054\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u8a8d\u5b9a\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u4fe1\u983c\u3067\u304d\u308b\u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u9078\u3076\u969b\u306b\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-is-iso-13485\">ISO13485\u3068\u306f\uff1f<\/h3>\n\n\n\n<p><strong><a href=\"https:\/\/en.wikipedia.org\/wiki\/ISO_13485\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a><\/strong> \u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u751f\u7523\u3001\u5236\u5fa1\u3001\u6d41\u901a\u306b\u7279\u5316\u3057\u305f\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u8981\u4ef6\u3092\u5b9a\u3081\u305f\u56fd\u969b\u898f\u683c\u3067\u3059\u3002\u3053\u306e\u898f\u683c\u306f\u3001\u88fd\u54c1\u304c <strong>\u898f\u5236<\/strong> \u304a\u3088\u3073 <strong>\u9867\u5ba2\u8981\u4ef6<\/strong> \u3092\u4e00\u8cab\u3057\u3066\u6e80\u305f\u3059\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u300cISO 13485:2016\u306f\u6700\u65b0\u7248\u3067\u3001\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u88fd\u54c1\u6e05\u6d44\u5ea6\u3001\u898f\u5236\u9075\u5b88\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002\u300d<\/p>\n<\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"why-it-matters-for-b2b-buyers\">B2B\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u7406\u7531<\/h3>\n\n\n\n<p>\u5378\u58f2\u696d\u8005\u3084\u30e1\u30fc\u30ab\u30fc\u304b\u3089\u8abf\u9054\u3059\u308b\u5834\u5408\u3001\u7279\u306b\u56fd\u5883\u3092\u8d8a\u3048\u308b\u5834\u5408\u3001\u8a8d\u5b9a\u306f <strong>\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u898f\u5236\u9069\u5408\u6027\u306e\u5b89\u5fc3\u3092\u63d0\u4f9b\u3057\u307e\u3059<\/strong>\u3002\u3053\u308c\u306f\u4ee5\u4e0b\u306e\u70b9\u3067\u91cd\u8981\u3067\u3059:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8ca9\u58f2\u696d\u8005<\/strong>: \u88fd\u54c1\u306e\u73fe\u5730\u304a\u3088\u3073\u56fd\u969b\u898f\u5236\u9075\u5b88\u3092\u78ba\u4fdd<\/li>\n\n\n\n<li><strong>\u75c5\u9662\u3068\u8a3a\u7642\u6240<\/strong>: \u60a3\u8005\u5b89\u5168\u306e\u305f\u3081\u306e\u8a8d\u5b9a\u30c7\u30d0\u30a4\u30b9\u306b\u4f9d\u5b58<\/li>\n\n\n\n<li><strong>E\u30b3\u30de\u30fc\u30b9\u533b\u7642\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc<\/strong>: \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u3078\u306e\u8a8d\u5b9a\u88fd\u54c1\u8ca9\u58f2\u306b\u81ea\u4fe1\u3092\u6301\u3064<\/li>\n\n\n\n<li><strong>\u653f\u5e9c\u5165\u672d<\/strong>: \u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u4f7f\u7528\u3057\u305f\u8abf\u9054\u9069\u683c\u6027\u306e\u5145\u8db3<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"iso-13485-certification-trust-in-the-supply-chain\">ISO 13485\u8a8d\u5b9a = \u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u4fe1\u983c<\/h3>\n\n\n\n<p>ISO\u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u63d0\u643a\u3059\u308b\u3053\u3068\u3067\u3001B2B\u30d0\u30a4\u30e4\u30fc\u306f\u30ea\u30b9\u30af\u66b4\u9732\u3092\u4f4e\u6e1b\u3057\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u5411\u4e0a\u3055\u305b\u3001EU\u3001\u7c73\u56fd\u3001\u30a2\u30b8\u30a2\u592a\u5e73\u6d0b\u306a\u3069\u306e\u898f\u5236\u4e3b\u5c0e\u5e02\u5834\u3067\u306e\u5730\u4f4d\u3092\u5f37\u5316\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"2-medical-device-market-trends-and-the-rising-demand-for-certified-suppliers\">2. \u533b\u7642\u6a5f\u5668\u5e02\u5834\u30c8\u30ec\u30f3\u30c9\u3068\u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u9700\u8981\u5897\u52a0<\/h2>\n\n\n\n<p>\u30b0\u30ed\u30fc\u30d0\u30eb\u533b\u7642\u6a5f\u5668\u5e02\u5834\u306f\u3001\u6280\u8853\u9032\u6b69\u3001\u30d8\u30eb\u30b9\u30b1\u30a2\u652f\u51fa\u306e\u5897\u52a0\u3001\u65e9\u671f\u75be\u60a3\u691c\u51fa\u306e\u9700\u8981\u306b\u3088\u308a\u6025\u901f\u306a\u6210\u9577\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u7af6\u4e89\u74b0\u5883\u306b\u304a\u3044\u3066\u3001 <strong>\u5bfe\u8c61\u89e3\u5256\u5b66\u306b\u6700\u9069\u5316\u3055\u308c\u305f\u30c1\u30c3\u30d7\u5f62\u72b6\uff08\u4e38\u578b\u3001\u30c6\u30fc\u30d1\u30fc\u578b\u3001\u30d6\u30e9\u30b7\u578b\uff09<\/strong> \u306f <strong>\u5e02\u5834\u5dee\u5225\u5316\u8981\u56e0<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"global-market-at-a-glance-2024-2028-projection\">\u3068\u3057\u3066\u6d6e\u4e0a\u3057\u3066\u3044\u307e\u3059 \u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u6982\u8981\uff082024\u20132028\u5e74\u4e88\u6e2c\uff09<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u5730\u57df<\/th><th>\u5e02\u5834\u898f\u6a21\uff082024\u5e74\uff09<\/th><th>CAGR\uff082024\u20132028\u5e74\uff09<\/th><th>\u8a8d\u8a3c\u9700\u8981<\/th><\/tr><\/thead><tbody><tr><td>\u5317\u7c73<\/td><td>2000\u5104\u30c9\u30eb\u8d85<\/td><td>5.5%<\/td><td>\u9ad8\u3044<\/td><\/tr><tr><td>\u30e8\u30fc\u30ed\u30c3\u30d1<\/td><td>1500\u5104\u30c9\u30eb\u8d85<\/td><td>6.3%<\/td><td>\u975e\u5e38\u306b\u9ad8\u3044<\/td><\/tr><tr><td>\u30a2\u30b8\u30a2\u592a\u5e73\u6d0b<\/td><td>1200\u5104\u30c9\u30eb\u8d85<\/td><td>8.1%<\/td><td>\u6025\u6fc0\u306b\u5897\u52a0\u4e2d<\/td><\/tr><tr><td>\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab<\/td><td>300\u5104\u30c9\u30eb<\/td><td>4.2%<\/td><td>\u4e2d\u7a0b\u5ea6<\/td><\/tr><tr><td>\u4e2d\u6771\u30fb\u30a2\u30d5\u30ea\u30ab<\/td><td>200\u5104\u30c9\u30eb<\/td><td>3.8%<\/td><td>\u4e2d\u7a0b\u5ea6<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"key-trends-driving-certification-adoption\">\u8a8d\u8a3c\u5c0e\u5165\u3092\u63a8\u9032\u3059\u308b\u4e3b\u8981\u30c8\u30ec\u30f3\u30c9<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u53b3\u683c\u5316\u3059\u308b\u30b0\u30ed\u30fc\u30d0\u30eb\u898f\u5236<\/strong>\uff1aEU\u306e\u65b0MDR\u3001\u7c73FDA\u306e\u66f4\u65b0\u3001\u4e2d\u56fdNMPA\u306a\u3069<\/li>\n\n\n\n<li><strong>\u56fd\u5883\u3092\u8d8a\u3048\u305fB2B\u8cbf\u6613<\/strong>\uff1a\u6d41\u901a\u696d\u8005\u306f\u56fd\u5185\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u8a8d\u8a3c\u6e08\u307f\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u597d\u3080<\/li>\n\n\n\n<li><strong>\u8a3a\u65ad\u691c\u67fb\u306e\u6210\u9577<\/strong>\uff1a\u7279\u306bCOVID-19\u4ee5\u964d\u3001ISO 13485\u6e96\u62e0\u306e\u691c\u67fb\u6d88\u8017\u54c1\u9700\u8981\u304c\u6025\u5897<\/li>\n\n\n\n<li><strong>\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u306e\u62e1\u5927<\/strong>\uff1a\u533b\u7642\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u30a6\u30a7\u30a2\u30e9\u30d6\u30eb\u6a5f\u5668\u3001\u63a5\u7d9a\u30c7\u30d0\u30a4\u30b9\u304c\u8a8d\u8a3c\u3092\u5fc5\u8981\u3068\u3059\u308b\u3088\u3046\u306b\u306a\u308b<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"b2b-search-trends-2023-2024\">B2B\u691c\u7d22\u30c8\u30ec\u30f3\u30c9\uff082023\u20132024\u5e74\uff09<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30ad\u30fc\u30ef\u30fc\u30c9\u30d5\u30ec\u30fc\u30ba<\/th><th>\u6708\u9593\u691c\u7d22\u30dc\u30ea\u30e5\u30fc\u30e0<\/th><th>\u7af6\u4e89\u5ea6<\/th><th>\u610f\u56f3\u30ec\u30d9\u30eb<\/th><\/tr><\/thead><tbody><tr><td>ISO 13485\u8a8d\u8a3c\u6e08\u307f\u533b\u7642\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc<\/td><td>2,400<\/td><td>\u4e2d<\/td><td>\u9ad8\u3044<\/td><\/tr><tr><td>\u5378\u58f2\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc<\/td><td>1,800<\/td><td>\u9ad8\u3044<\/td><td>\u9ad8\u3044<\/td><\/tr><tr><td>\u8a8d\u8a3c\u6e08\u307f\u8a3a\u65ad\u6d88\u8017\u54c1<\/td><td>1,100<\/td><td>\u4e2d<\/td><td>\u9ad8\u3044<\/td><\/tr><tr><td>ISO 13485\u691c\u67fb\u7528\u30b9\u30ef\u30d6\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc<\/td><td>950<\/td><td>\u4f4e\u3044<\/td><td>\u975e\u5e38\u306b\u9ad8\u3044<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u30c8\u30ec\u30f3\u30c9\u306f\u3001ISO 13485\u304c\u3082\u306f\u3084\u30aa\u30d7\u30b7\u30e7\u30f3\u3067\u306f\u306a\u304f\u2014 <strong>\u6226\u7565\u7684\u306a\u5fc5\u8981\u6027\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059<\/strong> \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u306f <strong>\u5fc5\u9808\u306e\u30d5\u30a3\u30eb\u30bf\u30fc<\/strong> \u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u306f\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2976\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2.jpg\" alt=\"\" class=\"wp-image-2976\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2967\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-1.jpg\" alt=\"\" class=\"wp-image-2967\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-1.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-1-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-1-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-1-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2965\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3.jpg\" alt=\"\" class=\"wp-image-2965\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"3-key-components-of-iso-13485-certification-for-medical-manufacturers-and-exporters\">3. \u533b\u7642\u30e1\u30fc\u30ab\u30fc\u304a\u3088\u3073\u8f38\u51fa\u696d\u8005\u5411\u3051ISO 13485\u8a8d\u5b9a\u306e\u4e3b\u8981\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8<\/h2>\n\n\n\n<p>ISO 13485\u57fa\u6e96\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u5168\u6bb5\u968e\u306b\u308f\u305f\u308b <strong>\u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/strong> \uff08QMS\uff09\u3092\u78ba\u7acb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8981\u7d20\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3001B2B\u30d0\u30a4\u30e4\u30fc\u306f\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u3088\u308a\u52b9\u679c\u7684\u306b\u8a55\u4fa1\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"essential-iso-13485-quality-management-elements\">ISO 13485\u54c1\u8cea\u7ba1\u7406\u306e\u5fc5\u9808\u8981\u7d20<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8<\/th><th>\u8aac\u660e<\/th><\/tr><\/thead><tbody><tr><td>\u6587\u66f8\u5316\u3055\u308c\u305fQMS<\/td><td>\u54c1\u8cea\u7ba1\u7406\u306e\u305f\u3081\u306e\u30dd\u30ea\u30b7\u30fc\u3001SOP\u3001\u4f5c\u696d\u6307\u793a\u66f8\u3001\u8a18\u9332\u304c\u5fc5\u8981<\/td><\/tr><tr><td>\u30ea\u30b9\u30af\u7ba1\u7406<\/td><td>\u88fd\u54c1\u8a2d\u8a08\u304b\u3089\u5e02\u5834\u5f8c\u76e3\u8996\u307e\u3067<\/td><\/tr><tr><td>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406<\/td><td>\u30d9\u30f3\u30c0\u30fc\u306e\u5b9a\u671f\u8a55\u4fa1\u3068\u8cc7\u683c\u8a8d\u5b9a<\/td><\/tr><tr><td>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/td><td>\u539f\u6750\u6599\u3001\u90e8\u54c1\u3001\u5b8c\u6210\u54c1\u306e\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/td><\/tr><tr><td>\u898f\u5236\u9075\u5b88<\/td><td>EU MDR\u3001FDA 21 CFR Part 820\u3001NMPA\u306a\u3069\u306e\u898f\u5236\u9075\u5b88\u80fd\u529b<\/td><\/tr><tr><td>\u82e6\u60c5\u51e6\u7406<\/td><td>\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3001\u30ea\u30bf\u30fc\u30f3\u3001\u4e0d\u5177\u5408\u4e8b\u8c61\u306e\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>\u5185\u90e8\u76e3\u67fb\u3068CAPA<\/td><td>\u76e3\u67fb\u3068\u662f\u6b63\u63aa\u7f6e\u3092\u901a\u3058\u305f\u7d99\u7d9a\u7684\u6539\u5584<\/td><\/tr><tr><td>\u6ec5\u83cc\u3068\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u5236\u5fa1<\/td><td>\u6d88\u8017\u54c1\u304a\u3088\u3073\u4fb5\u8972\u7684\u533b\u7642\u88fd\u54c1\u306b\u4e0d\u53ef\u6b20<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-this-means-for-b2b-buyers\">B2B\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u306e\u610f\u5473<\/h3>\n\n\n\n<p>\u5378\u58f2\u533b\u7642\u6d88\u8017\u54c1\u3084\u6a5f\u5668\u3092\u8abf\u9054\u3059\u308b\u969b\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u4ee5\u4e0b\u3092\u78ba\u5b9f\u306b\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\uff1a<\/p>\n\n\n\n<p>\u2705 ISO 13485\u8a8d\u8a3c\u66f8\u306e\u6587\u66f8\u3092\u63d0\u4f9b<br>\u2705 \u5404\u30d0\u30c3\u30c1\u3068\u30ed\u30c3\u30c8\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u6709\u3059\u308b<br>\u2705 \u898f\u5236\u9075\u5b88\u306e\u8a3c\u660e\uff08CE\u3001FDA\u306a\u3069\uff09\u3092\u63d0\u4f9b<br>\u2705 \u8ca9\u58f2\u5f8c\u30b5\u30dd\u30fc\u30c8\u3068\u82e6\u60c5\u89e3\u6c7a\u3092\u7ba1\u7406<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"red-flags-when-evaluating-suppliers\">\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8a55\u4fa1\u6642\u306e\u6ce8\u610f\u70b9<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u671f\u9650\u5207\u308c\u307e\u305f\u306f\u691c\u8a3c\u4e0d\u80fd\u306aISO\u8a8d\u8a3c\u66f8<\/li>\n\n\n\n<li>\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u3084\u82e6\u60c5\u306b\u5bfe\u3059\u308b\u660e\u78ba\u306aSOP\u306e\u6b20\u5982<\/li>\n\n\n\n<li>\u76e3\u67fb\u6642\u306e\u6587\u66f8\u5316\u306e\u4e0d\u5099<\/li>\n\n\n\n<li>\u6ec5\u83cc\u88fd\u54c1\u306e\u305f\u3081\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u65bd\u8a2d\u306e\u6b20\u5982<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u3089\u306eISO\u8981\u4ef6\u3078\u306e\u9075\u5b88\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3067\u3001\u30d6\u30e9\u30f3\u30c9\u3001\u9867\u5ba2\u3001\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u3092\u4fdd\u8b77\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"4-top-iso-13485-certified-medical-device-suppliers-worldwide\">4. \u4e16\u754c\u306e\u30c8\u30c3\u30d7ISO 13485\u8a8d\u5b9a\u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc<\/h2>\n\n\n\n<p>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30c8\u3067\u9ad8\u54c1\u8cea\u306a\u533b\u7642\u88fd\u54c1\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u9700\u8981\u304c\u5897\u5927\u3059\u308b\u4e2d\u3001ISO 13485\u8a8d\u8a3c\u306f\u4e00\u6d41\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8a55\u4fa1\u306e\u4e3b\u8981\u6307\u6a19\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6d41\u901a\u696d\u8005\u3001\u75c5\u9662\u8abf\u9054\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3001e\u30b3\u30de\u30fc\u30b9\u5378\u58f2\u696d\u8005\u3044\u305a\u308c\u3067\u3042\u3063\u3066\u3082\u3001\u8a8d\u8a3c\u6e08\u307f\u4f01\u696d\u304b\u3089\u306e\u8abf\u9054\u306f\u88fd\u54c1\u54c1\u8cea\u3001\u898f\u5236\u9075\u5b88\u3001\u4fe1\u983c\u3067\u304d\u308b\u7d0d\u54c1\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4ee5\u4e0b\u3067\u306f\u3001\u4e3b\u8981\u5730\u57df\u306e\u512a\u308c\u305fISO 13485\u8a8d\u8a3c\u6e08\u307f\u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u3044\u304f\u3064\u304b\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"global-leaders-in-iso-13485-certified-medical-supplies\">\ud83c\udf0d ISO 13485\u8a8d\u8a3c\u6e08\u307f\u533b\u7642\u7528\u54c1\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u30ea\u30fc\u30c0\u30fc<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u4f1a\u793e\u540d<\/th><th>\u5730\u57df<\/th><th>\u5c02\u9580\u5206\u91ce<\/th><th>ISO 13485\u306e\u9069\u7528\u7bc4\u56f2<\/th><th>\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8<\/th><\/tr><\/thead><tbody><tr><td><strong>\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853<\/strong><\/td><td>\u4e2d\u56fd<\/td><td>\u533b\u7642\u691c\u67fb\u6d88\u8017\u54c1\uff08\u30b9\u30ef\u30d6\u3001\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7\u3001\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30ad\u30c3\u30c8\uff09<\/td><td>\u7814\u7a76\u958b\u767a\u3001\u751f\u7523\u3001\u8f38\u51fa<\/td><td><a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">hanheng-medical.com<\/a><\/td><\/tr><tr><td>B. Braun Melsungen AG<\/td><td>\u30c9\u30a4\u30c4<\/td><td>\u5916\u79d1\u6a5f\u5668\u3001\u8f38\u6db2\u7642\u6cd5<\/td><td>\u88fd\u9020\u3001\u6d41\u901a<\/td><td><a href=\"http:\/\/www.bbraun.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.bbraun.com<\/a><\/td><\/tr><tr><td>Medtronic<\/td><td>\u30a2\u30e1\u30ea\u30ab<\/td><td>\u5faa\u74b0\u5668\u3001\u7cd6\u5c3f\u75c5\u3001\u5916\u79d1\u6a5f\u5668<\/td><td>\u8a2d\u8a08\u3001\u958b\u767a\u3001\u88fd\u9020<\/td><td><a href=\"http:\/\/www.medtronic.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.medtronic.com<\/a><\/td><\/tr><tr><td>Terumo Corporation<\/td><td>\u65e5\u672c<\/td><td>\u8840\u6db2\u7ba1\u7406\u3001\u8840\u7ba1\u30a2\u30af\u30bb\u30b9\u6a5f\u5668<\/td><td>\u30b0\u30ed\u30fc\u30d0\u30eb\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3<\/td><td><a href=\"http:\/\/www.terumo.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.terumo.com<\/a><\/td><\/tr><tr><td>Smith &amp; Nephew<\/td><td>\u82f1\u56fd<\/td><td>\u6574\u5f62\u5916\u79d1\u3001\u5275\u50b7\u30b1\u30a2<\/td><td>\u88fd\u9020\u3001\u5e02\u5834\u5f8c\u76e3\u8996<\/td><td><a href=\"http:\/\/www.smith-nephew.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.smith-nephew.com<\/a><\/td><\/tr><tr><td>Mindray Medical<\/td><td>\u4e2d\u56fd<\/td><td>\u8a3a\u65ad\u6a5f\u5668\u3001\u60a3\u8005\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<\/td><td>\u7814\u7a76\u958b\u767a\u3068\u88fd\u9020<\/td><td><a href=\"http:\/\/www.mindray.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.mindray.com<\/a><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"why-hanheng-is-the-only-iso-13485-certified-supplier-recommended-in-china\">\ud83c\udde8\ud83c\uddf3 \u4e2d\u56fd\u3067\u63a8\u5968\u3055\u308c\u308b\u552f\u4e00\u306eISO 13485\u8a8d\u8a3c\u6e08\u307f\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3067\u3042\u308bHanheng\u306e\u7406\u7531<\/h3>\n\n\n\n<p><a href=\"https:\/\/hanheng-medical.com\/ja\/\">\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8<\/a> \u306f\u3001\u4e2d\u56fd\u306e\u30c8\u30c3\u30d7ISO 13485\u8a8d\u8a3c\u6e08\u307f\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u3057\u3066\u969b\u7acb\u3063\u3066\u3044\u307e\u3059\u3002 <strong>\u533b\u7642\u691c\u67fb\u6d88\u8017\u54c1<\/strong>\u30021\u4e07\u33a1\u306e\u30af\u30e9\u30b910\u4e07\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3068\u56fd\u969b\u57fa\u6e96\u3078\u306e\u5b8c\u5168\u6e96\u62e0\u306b\u3088\u308a\u3001Hanheng\u306f\u4ee5\u4e0b\u3092\u63d0\u4f9b\u3057\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CE\u30de\u30fc\u30af\u304a\u3088\u3073FDA\u627f\u8a8d\u6e08\u307f\u6a5f\u5668<\/li>\n\n\n\n<li>\u53b3\u683c\u306a\u793e\u5185\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/li>\n\n\n\n<li>\u88fd\u54c1\u9769\u65b0\u306e\u305f\u3081\u306e\u9ad8\u5ea6\u306a\u7814\u7a76\u958b\u767a<\/li>\n\n\n\n<li>\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u6587\u66f8\u5316<\/li>\n\n\n\n<li>\u591a\u7279\u8a31\u53d6\u5f97\u306e\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30c4\u30fc\u30eb\u304a\u3088\u3073\u5a66\u4eba\u79d1\u30ad\u30c3\u30c8<\/li>\n<\/ul>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u300c\u4e2d\u56fd\u306eISO 13485\u8a8d\u8a3c\u6e08\u307f\u30e1\u30fc\u30ab\u30fc\u3092\u6c42\u3081\u308bB2B\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u3001 <strong>Hanheng\u306f\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u696d\u754c\u57fa\u6e96<\/strong> \u3067\u3059\u3002\u300d<\/p>\n<\/blockquote>\n\n\n\n<p>\u5378\u58f2\u30d0\u30a4\u30e4\u30fc\u306e\u7686\u69d8\u306f\u3001 <a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a> \u3067\u30d5\u30eb\u88fd\u54c1\u30ab\u30bf\u30ed\u30b0\u3092\u3054\u89a7\u3044\u305f\u3060\u304f\u304b\u3001 <strong><a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><\/strong>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"dGXBL2WWVZ\"><a href=\"https:\/\/hanheng-medical.com\/ja\/product\/cervical-scancer-screening-cervix-cervical-brushboom-like-device-8306\/\">\u5b50\u5bae\u9838\u304c\u3093\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u5b50\u5bae\u9838\u90e8\/\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7\uff08\u30d6\u30fc\u30e0\u306e\u3088\u3046\u306a\u30c7\u30d0\u30a4\u30b9\uff098306<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u300c\u5b50\u5bae\u9838\u304c\u3093\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u5b50\u5bae\u9838\u90e8\/\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7\uff08\u30d6\u30fc\u30e0\u306e\u3088\u3046\u306a\u30c7\u30d0\u30a4\u30b9\uff098306\u300d\u2014 Hanheng Medical\" src=\"https:\/\/hanheng-medical.com\/product\/cervical-scancer-screening-cervix-cervical-brushboom-like-device-8306\/embed\/#?secret=5MQV7dHfsV#?secret=dGXBL2WWVZ\" data-secret=\"dGXBL2WWVZ\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"5-why-more-distributors-are-prioritizing-iso-13485-certified-partners\">5. \u3088\u308a\u591a\u304f\u306e\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u304cISO 13485\u8a8d\u5b9a\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u512a\u5148\u3059\u308b\u7406\u7531<\/h2>\n\n\n\n<p>\u55b6\u696d\u30c1\u30fc\u30e0\u306b\u76f4\u63a5\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002 <strong>\u307e\u3059\u307e\u3059\u898f\u5236\u304c\u53b3\u3057\u304f\u306a\u308b\u30d8\u30eb\u30b9\u30b1\u30a2\u74b0\u5883\u306b\u304a\u3044\u3066\u3001\u533b\u7642\u88fd\u54c1\u6d41\u901a\u696d\u8005\u306f\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u304c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30c8\u3067\u30c8\u30ec\u30fc\u30b5\u30d6\u30eb\u3001\u9ad8\u54c1\u8cea\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u4fdd\u3059\u308b\u30d7\u30ec\u30c3\u30b7\u30e3\u30fc\u306b\u3055\u3089\u3055\u308c\u3066\u3044\u307e\u3059\u3002ISO 13485\u8a8d\u8a3c\u306f<\/strong> \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u9078\u629e\u3059\u308b\u969b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"key-reasons-distributors-choose-certified-manufacturers\">\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u304c\u8a8d\u5b9a\u30e1\u30fc\u30ab\u30fc\u3092\u9078\u3076\u4e3b\u306a\u7406\u7531<\/h3>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"regulatory-compliance\">\u2705 \u898f\u5236\u9075\u5b88<\/h4>\n\n\n\n<p>\u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u56fd\u969b\u7684\u306a\u6cd5\u7684\u8981\u4ef6\uff08EU MDR\u3001FDA \u306a\u3069\uff09\u3092\u6e80\u305f\u3057\u3066\u304a\u308a\u3001\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306e\u6cd5\u7684\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"quality-assurance\">\u2705 \u54c1\u8cea\u4fdd\u8a3c<\/h4>\n\n\n\n<p>ISO 13485 \u306f\u4e00\u8cab\u3057\u305f\u88fd\u54c1\u54c1\u8cea\u3001\u30d0\u30c3\u30c1\u7ba1\u7406\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u4fdd\u8a3c\u3057\u3001\u654f\u611f\u306a\u533b\u7642\u6a5f\u5668\u306b\u3068\u3063\u3066\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"competitive-advantage\">\u2705 \u7af6\u4e89\u512a\u4f4d\u6027<\/h4>\n\n\n\n<p>\u8a8d\u5b9a\u88fd\u54c1\u306e\u8ca9\u58f2\u306f\u3001\u75c5\u9662\u3001\u30af\u30ea\u30cb\u30c3\u30af\u3001\u653f\u5e9c\u8abf\u9054\u8005\u304b\u3089\u306e\u4fe1\u983c\u3092\u9ad8\u3081\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"risk-mitigation\">\u2705 \u30ea\u30b9\u30af\u8efd\u6e1b<\/h4>\n\n\n\n<p>\u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u5f37\u56fa\u306a\u82e6\u60c5\u51e6\u7406\u3001CAPA \u30b7\u30b9\u30c6\u30e0\u3001\u30ea\u30b3\u30fc\u30eb\u624b\u9806\u3092\u7dad\u6301\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"market-access\">\u2705 \u5e02\u5834\u30a2\u30af\u30bb\u30b9<\/h4>\n\n\n\n<p>\u591a\u304f\u306e\u5165\u672d\u3084\u8abf\u9054\u5951\u7d04\u3067\u306f\u3001\u53c2\u52a0\u306b ISO 13485 \u8a8d\u5b9a\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"distributor-case-study-example\">\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u4e8b\u4f8b\u7814\u7a76\u4f8b<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306e\u7a2e\u985e<\/th><th>\u76ee\u6a19<\/th><th>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u898f\u5236\u76e3\u67fb\u306e\u305f\u3081\u306b\u3001\u5e38\u306b\u30d0\u30c3\u30c1\u756a\u53f7\u3068\u30ed\u30c3\u30c8\u30b3\u30fc\u30c9\u3092\u4fdd\u6301\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/th><th>\u624b\u98069\uff1a\u6d41\u901a\u307e\u305f\u306f\u691c\u67fb\u30d1\u30a4\u30d7\u30e9\u30a4\u30f3\u3068\u306e\u7d71\u5408<\/th><th>\u7d50\u679c<\/th><\/tr><\/thead><tbody><tr><td>EU \u62e0\u70b9\u306e\u75c5\u9662\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc<\/td><td>\u304c\u3093\u691c\u8a3a\u7528\u306e\u5b50\u5bae\u9838\u90e8\u30b9\u30ef\u30d6\u3092\u8abf\u9054<\/td><td>\u73fe\u5730\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c EU MDR \u306b\u6e96\u62e0\u3057\u3066\u3044\u306a\u3044<\/td><td>ISO 13485 \u8a8d\u5b9a\u306e Hanheng \u3068\u63d0\u643a<\/td><td>3 \u5e74\u9593\u306e\u75c5\u9662\u5951\u7d04\u3092\u7372\u5f97<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u8a8d\u5b9a\u30e1\u30fc\u30ab\u30fc\u306e\u3088\u3046\u306a<a href=\"https:\/\/hanheng-medical.com\/ja\/\"> <strong>\u6c5f\u8607\u6f22\u6052<\/strong><\/a>\u3068\u9023\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306f\u6b21\u306e\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u65b0\u3057\u3044\u898f\u5236\u5e02\u5834\u3078\u306e\u62e1\u5927<\/li>\n\n\n\n<li>\u30d0\u30a4\u30e4\u30fc\u306e\u4fe1\u983c\u5411\u4e0a<\/li>\n\n\n\n<li>\u30b3\u30b9\u30c8\u306e\u304b\u304b\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u554f\u984c\u306e\u56de\u907f<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"G1VX8u1Pai\"><a href=\"https:\/\/hanheng-medical.com\/ja\/product\/cytological-brush-pap-smear-chlamydia-hpv-screening-protective-bulb-tip-protective-sheath-molded-breakpoint-37mm-8130b21\/\">\u7d30\u80de\u8a3a\u30d6\u30e9\u30b7\/\u30d1\u30c3\u30d7\u30b9\u30e1\u30a2\/\u30af\u30e9\u30df\u30b8\u30a2\/HPV\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\/\u4fdd\u8b77\u7403\u72b6\u5148\u7aef\/\u4fdd\u8b77\u30b7\u30fc\u30b9\/\u6210\u5f62\u30d6\u30ec\u30fc\u30af\u30dd\u30a4\u30f3\u30c837mm 8130B21<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u7d30\u80de\u8a3a\u30d6\u30e9\u30b7\/\u30d1\u30c3\u30d7\u30b9\u30e1\u30a2\/\u30af\u30e9\u30df\u30b8\u30a2\/HPV\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\/\u4fdd\u8b77\u96fb\u7403\u30c1\u30c3\u30d7\/\u4fdd\u8b77\u30b7\u30fc\u30b9\/\u6210\u5f62\u30d6\u30ec\u30fc\u30af\u30dd\u30a4\u30f3\u30c837mm 8130B21\u201d \u2014 \u6f22\u6052\u30e1\u30c7\u30a3\u30ab\u30eb\" src=\"https:\/\/hanheng-medical.com\/product\/cytological-brush-pap-smear-chlamydia-hpv-screening-protective-bulb-tip-protective-sheath-molded-breakpoint-37mm-8130b21\/embed\/#?secret=vX9QtuKzFn#?secret=G1VX8u1Pai\" data-secret=\"G1VX8u1Pai\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"6-why-choose-jiangsu-hanheng-as-your-iso-13485-certified-medical-consumables-supplier\">6. ISO 13485\u8a8d\u5b9a\u533b\u7642\u6d88\u8017\u54c1\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u3057\u3066Jiangsu Hanheng\u3092\u9078\u3076\u7406\u7531<\/h2>\n\n\n\n<p>\u8abf\u9054\u3059\u308b\u969b\u306b\u306f <strong>\u6ec5\u83cc\u6e08\u307f\u3067\u4fe1\u983c\u6027\u304c\u9ad8\u304f\u3001\u898f\u5236\u306b\u6e96\u62e0\u3057\u305f\u533b\u7642\u691c\u67fb\u6d88\u8017\u54c1<\/strong>\u3001Jiangsu Hanheng \u306f B2B \u30d0\u30a4\u30e4\u30fc\u306b\u5bfe\u3057\u3066\u6bd4\u985e\u306a\u304d\u4fa1\u5024\u3068\u4e00\u8cab\u6027\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"company-snapshot\">\ud83c\udf1f \u4f1a\u793e\u6982\u8981<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u7279\u5fb4<\/th><th>\u8a73\u7d30<\/th><\/tr><\/thead><tbody><tr><td>\u8a2d\u7acb<\/td><td>2018<\/td><\/tr><tr><td>\u65bd\u8a2d\u898f\u6a21<\/td><td>ISO 9001\u3001ISO 13485\u3001CE\u3001FDA\u3001\u8907\u6570\u306e\u5b9f\u7528\u65b0\u6848\u7279\u8a31<\/td><\/tr><tr><td>\u8a8d\u8a3c<\/td><td>ISO 13485\u3001ISO 9001\u3001CE\u3001FDA\u3001\u5b9f\u7528\u65b0\u6848\u7279\u8a31<\/td><\/tr><tr><td>\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/td><td>\u9f3b\u8154\/\u54bd\u982d\u30b9\u30ef\u30d6\u3001\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30eb\u30b3\u30ec\u30af\u30bf\u30fc\u3001\u30d6\u30e9\u30b7\u3001\u30ad\u30c3\u30c8<\/td><\/tr><tr><td>\u5c02\u9580\u5206\u91ce<\/td><td>\u8a3a\u65ad\u304a\u3088\u3073\u5a66\u4eba\u79d1\u5411\u3051\u306e\u9ad8\u6027\u80fd\u533b\u7642\u6d88\u8017\u54c1<\/td><\/tr><tr><td>\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u91cd\u8996<\/td><td>\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306e R&amp;D \u3068\u7d99\u7d9a\u7684\u306a\u6027\u80fd\u6700\u9069\u5316<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-sets-hanheng-apart\">\ud83d\udd0d Hanheng \u306e\u72ec\u81ea\u6027\u3068\u306f\uff1f<\/h3>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"1-robust-iso-13485-compliance\">1. \u5f37\u56fa\u306a ISO 13485 \u6e96\u62e0<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u3059\u3079\u3066\u306e\u751f\u7523\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u306b\u5bfe\u3059\u308b\u5b8c\u5168\u306a\u6587\u66f8\u5316<\/li>\n\n\n\n<li>\u539f\u6750\u6599\u304b\u3089\u6700\u7d42\u5305\u88c5\u307e\u3067\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/li>\n\n\n\n<li>\u6ec5\u83cc\u751f\u7523\u74b0\u5883\u304c\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"2-global-ready-certifications\">2. \u30b0\u30ed\u30fc\u30d0\u30eb\u5bfe\u5fdc\u306e\u8a8d\u5b9a<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EU\u5e02\u5834\u5411\u3051CE\u8a8d\u8a3c\u53d6\u5f97\u6e08\u307f<\/li>\n\n\n\n<li>\u7c73\u56fd\u5411\u3051 FDA \u627f\u8a8d\u6e08\u307f<\/li>\n\n\n\n<li>ISO 13485 \u304c\u30b0\u30ed\u30fc\u30d0\u30eb\u6d41\u901a\u306e\u6e96\u5099\u3092\u4fdd\u8a3c<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"3-comprehensive-product-line\">3. \u5305\u62ec\u7684\u306a\u88fd\u54c1\u30e9\u30a4\u30f3<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>PAP \u30b9\u30e1\u30a2\u304a\u3088\u3073 HPV \u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u7528\u306e\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7<\/li>\n\n\n\n<li>\u547c\u5438\u5668\u30a6\u30a4\u30eb\u30b9\u691c\u51fa\uff08COVID-19\u3001RSV\u3001\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\uff09\u7528\u306e\u9f3b\u54bd\u982d\u30b9\u30ef\u30d6<\/li>\n\n\n\n<li>\u5b8c\u5168\u306a\u5a66\u4eba\u79d1\u7528\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30ad\u30c3\u30c8<\/li>\n\n\n\n<li>OEM \u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u5411\u3051\u306e\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u53ef\u80fd\u306a\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30dc\u30c3\u30af\u30b9\u3068\u5305\u88c5<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"4-advanced-manufacturing-r-d\">4. \u5148\u9032\u7684\u306a\u88fd\u9020\u304a\u3088\u3073 R&amp;D<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e00\u8cab\u3057\u305f\u54c1\u8cea\u306e\u305f\u3081\u306e\u9ad8\u901f\u81ea\u52d5\u5316<\/li>\n\n\n\n<li>\u6750\u6599\u8a66\u9a13\u304a\u3088\u3073\u65b0\u88fd\u54c1\u8a2d\u8a08\u306e\u305f\u3081\u306e\u793e\u5185\u30e9\u30dc<\/li>\n\n\n\n<li>\u5c02\u4efb R&amp;D \u30c1\u30fc\u30e0\u304c\u5e02\u5834\u30cb\u30fc\u30ba\u3078\u306e\u8fc5\u901f\u306a\u9069\u5fdc\u3092\u4fdd\u8a3c<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"product-examples-from-hanheng\">\ud83e\uddea Hanheng \u306e\u88fd\u54c1\u4f8b<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u88fd\u54c1\u540d<\/th><th>\u30e6\u30fc\u30b9\u30b1\u30fc\u30b9<\/th><th>\u4e3b\u306a\u7279\u5fb4<\/th><\/tr><\/thead><tbody><tr><td>\u9f3b\/\u5589\u30b9\u30ef\u30d6<\/td><td>\u547c\u5438\u5668\u30a6\u30a4\u30eb\u30b9\u691c\u51fa<\/td><td>\u30d5\u30ed\u30c3\u30ad\u30f3\u30b0\u30c1\u30c3\u30d7\u3001\u6ec5\u83cc\u3001\u500b\u5225\u5305\u88c5<\/td><\/tr><tr><td>\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30eb\u30b3\u30ec\u30af\u30bf\u30fc<\/td><td>HPV \u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3001PAP \u30b9\u30e1\u30a2<\/td><td>\u4eba\u9593\u5de5\u5b66\u7684\u306a\u30cf\u30f3\u30c9\u30eb\u3001\u6ec5\u83cc\u5305\u88c5<\/td><\/tr><tr><td>\u6ec5\u83cc\u5b50\u5bae\u9838\u7ba1\u30d6\u30e9\u30b7<\/td><td>\u5a66\u4eba\u79d1\u691c\u67fb<\/td><td>\u67d4\u3089\u304b\u3044\u30d6\u30e9\u30b7\u3001CE \u30de\u30fc\u30af\u4ed8\u304d\u3001ISO 13485 \u6e96\u62e0<\/td><\/tr><tr><td>\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30dc\u30c3\u30af\u30b9<\/td><td>\u533b\u7642\u7269\u6d41\u304a\u3088\u3073\u4fdd\u7ba1<\/td><td>\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u53ef\u80fd\u3001\u5bc6\u9589\u3001\u8010\u6539\u3056\u3093<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"trusted-by-global-b2b-buyers\">\ud83c\udfc6 \u30b0\u30ed\u30fc\u30d0\u30eb B2B \u30d0\u30a4\u30e4\u30fc\u304b\u3089\u4fe1\u983c<\/h3>\n\n\n\n<p>Hanheng \u306e\u88fd\u54c1\u306f\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u75c5\u9662\u304a\u3088\u3073\u8a3a\u65ad\u30e9\u30dc\u30e9\u30c8\u30ea\u30fc<\/li>\n\n\n\n<li>\u56fd\u5bb6\u4fdd\u5065\u30d7\u30ed\u30b0\u30e9\u30e0<\/li>\n\n\n\n<li>\u5b66\u8853\u7814\u7a76\u6a5f\u95a2<\/li>\n\n\n\n<li>E\u30b3\u30de\u30fc\u30b9\u533b\u7642\u4f9b\u7d66\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/li>\n<\/ul>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u300cISO 13485 \u8a8d\u5b9a\u3068\u30b0\u30ed\u30fc\u30d0\u30eb\u898f\u5236\u627f\u8a8d\u306b\u3088\u308a\u3001Jiangsu Hanheng \u306f\u54c1\u8cea\u3001\u4e00\u8cab\u6027\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u6c42\u3081\u308b B2B \u30d0\u30a4\u30e4\u30fc\u306e\u4fe1\u983c\u3067\u304d\u308b\u30d1\u30fc\u30c8\u30ca\u30fc\u3067\u3059\u3002\u300d<\/p>\n<\/blockquote>\n\n\n\n<p>\ud83d\udce9 <strong>\u5378\u58f2\u898b\u7a4d\u3082\u308a\u307e\u305f\u306f\u88fd\u54c1\u30ab\u30bf\u30ed\u30b0\u3092\u30ea\u30af\u30a8\u30b9\u30c8\u3059\u308b\u306b\u306f<\/strong>\u3001\u30e1\u30fc\u30eb\uff1a <strong><a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><\/strong><br>\ud83c\udf10 \u8a2a\u554f\uff1a <a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"7-how-to-vet-and-order-from-iso-13485-certified-medical-device-suppliers\">7. ISO 13485\u8a8d\u5b9a\u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u5be9\u67fb\u3057\u6ce8\u6587\u3059\u308b\u65b9\u6cd5<\/h2>\n\n\n\n<p>B2B \u30d0\u30a4\u30e4\u30fc\u3001\u7279\u306b\u8abf\u9054\u3001\u6d41\u901a\u3001\u5378\u58f2\u306b\u5f93\u4e8b\u3059\u308b\u65b9\u306b\u3068\u3063\u3066\u3001ISO 13485 \u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u306e\u8abf\u9054\u3092\u6210\u529f\u3055\u305b\u308b\u306b\u306f\u3001\u69cb\u9020\u5316\u3055\u308c\u305f\u5be9\u67fb\u3068\u767a\u6ce8\u30d7\u30ed\u30bb\u30b9\u304c\u5fc5\u8981\u3067\u3059\u3002\u8a3a\u65ad\u30b9\u30ef\u30d6\u3001\u5b50\u5bae\u9838\u90e8\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u30c4\u30fc\u30eb\u3001\u5a66\u4eba\u79d1\u30ad\u30c3\u30c8\u3092\u8cfc\u5165\u3059\u308b\u5834\u5408\u3067\u3082\u3001\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u306b\u5f93\u3046\u3053\u3068\u3067\u3001\u52b9\u7387\u7684\u3067\u6e96\u62e0\u6027\u304c\u9ad8\u304f\u3001\u53ce\u76ca\u6027\u306e\u9ad8\u3044\u8abf\u9054\u6c7a\u5b9a\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"step-by-step-guide-to-vetting-iso-13485-certified-suppliers\">\ud83d\udd0d ISO 13485 \u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u5be9\u67fb\u30b9\u30c6\u30c3\u30d7\u30d0\u30a4\u30b9\u30c6\u30c3\u30d7\u30ac\u30a4\u30c9<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30b9\u30c6\u30c3\u30d7<\/th><th>\u884c\u52d5<\/th><th>\u76ee\u7684<\/th><\/tr><\/thead><tbody><tr><td>1<\/td><td>ISO 13485 \u8a3c\u660e\u66f8\u306e\u30b3\u30d4\u30fc\u3092\u30ea\u30af\u30a8\u30b9\u30c8<\/td><td>\u771f\u6b63\u6027\u3001\u7bc4\u56f2\u3001\u6709\u52b9\u671f\u9650\u3092\u78ba\u8a8d<\/td><\/tr><tr><td>2<\/td><td>\u767a\u884c\u8a8d\u8a3c\u6a5f\u95a2\u3092\u78ba\u8a8d<\/td><td>IAF \u8a8d\u5b9a\u6a5f\u95a2\uff08\u4f8b: T\u00dcV\u3001SGS\u3001BSI\uff09\u306b\u3088\u308b\u8a8d\u5b9a\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d<\/td><\/tr><tr><td>3<\/td><td>\u88fd\u54c1\u898f\u5236\u627f\u8a8d\u3092\u8981\u6c42<\/td><td>\u5e02\u5834\u306b\u5fdc\u3058\u305f CE\u3001FDA\u3001NMPA<\/td><\/tr><tr><td>4<\/td><td>QMS \u6587\u66f8\u3092\u30ec\u30d3\u30e5\u30fc<\/td><td>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001CAPA\u3001\u6ec5\u83cc\u3001\u30d0\u30c3\u30c1\u8a18\u9332\u306b\u95a2\u3059\u308b\u30dd\u30ea\u30b7\u30fc<\/td><\/tr><tr><td>5<\/td><td>\u4eee\u60f3\u307e\u305f\u306f\u73fe\u5730\u76e3\u67fb\u3092\u5b9f\u65bd<\/td><td>\u65bd\u8a2d\uff08\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3001\u81ea\u52d5\u5316\u3001\u5305\u88c5\u3001\u6587\u66f8\uff09\u3092\u8a55\u4fa1<\/td><\/tr><tr><td>6<\/td><td>\u88fd\u54c1\u8a66\u9a13\u80fd\u529b\u3092\u8a55\u4fa1<\/td><td>\u6ec5\u83cc\u3068\u54c1\u8cea\u691c\u8a3c\u3092\u78ba\u4fdd\uff08\u7279\u306b\u6d88\u8017\u54c1\u306e\u5834\u5408\uff09<\/td><\/tr><tr><td>7<\/td><td>\u7269\u6d41\u3068\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0\u3092\u78ba\u8a8d<\/td><td>\u914d\u9001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3001MOQ\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u914d\u9001\u80fd\u529b\u3092\u78ba\u8a8d<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"ordering-medical-consumables-from-a-certified-supplier-like-hanheng\">\ud83d\udce6 Hanheng \u306e\u3088\u3046\u306a\u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u306e\u533b\u7642\u6d88\u8017\u54c1\u767a\u6ce8<\/h3>\n\n\n\n<p><a href=\"https:\/\/hanheng-medical.com\/ja\/about-us\/\">\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8<\/a> \u306f\u3001\u75c5\u9662\u3001\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u3001\u533b\u7642 e \u30b3\u30de\u30fc\u30b9\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u30b7\u30fc\u30e0\u30ec\u30b9\u306a\u8abf\u9054\u3067\u30b5\u30dd\u30fc\u30c8\u3059\u308b B2B \u767a\u6ce8\u30b7\u30b9\u30c6\u30e0\u3092\u6700\u9069\u5316\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"ordering-process-with-hanheng\">\ud83d\udcdd Hanheng \u3067\u306e\u767a\u6ce8\u30d7\u30ed\u30bb\u30b9<\/h4>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u88fd\u54c1\u9078\u629e<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u5e45\u5e83\u3044\u30ab\u30bf\u30ed\u30b0\u304b\u3089\u9078\u629e\uff1a\u9f3b\u8154\/\u54bd\u982d\u30b9\u30ef\u30d6\u3001\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7\u3001\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30dc\u30c3\u30af\u30b9\u3001\u30ad\u30c3\u30c8<\/li>\n\n\n\n<li>\u4ed5\u69d8\u306b\u57fa\u3065\u304f\u30ab\u30b9\u30bf\u30e0 OEM\/ODM \u53ef\u80fd<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u8a8d\u5b9a\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ec\u30d3\u30e5\u30fc<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u8981\u6c42\u306b\u5fdc\u3058\u3066 ISO 13485\u3001CE\u3001FDA \u8a8d\u5b9a\u3092\u63d0\u4f9b<\/li>\n\n\n\n<li>\u898f\u5236\u7533\u8acb\u306e\u305f\u3081\u306e\u6280\u8853\u30c7\u30fc\u30bf\u30b7\u30fc\u30c8\u304a\u3088\u3073 MSDS \u306b\u30a2\u30af\u30bb\u30b9<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u898b\u7a4d\u3082\u308a\u304a\u3088\u3073 MOQ \u5354\u8b70<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u6570\u91cf\u968e\u5c64\u306b\u57fa\u3065\u304f\u900f\u660e\u306a\u4fa1\u683c\u8a2d\u5b9a<\/li>\n\n\n\n<li>\u5c0f\u898f\u6a21\u304a\u3088\u3073\u5927\u898f\u6a21\u30d0\u30a4\u30e4\u30fc\u306b\u5bfe\u5fdc\u3057\u305f MOQ<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u30b5\u30f3\u30d7\u30eb\u30ea\u30af\u30a8\u30b9\u30c8\uff08\u30aa\u30d7\u30b7\u30e7\u30f3\uff09<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u672c\u6ce8\u6587\u524d\u306b\u88fd\u54c1\u54c1\u8cea\u3092\u8a55\u4fa1<\/li>\n\n\n\n<li>\u5404\u30b5\u30f3\u30d7\u30eb\u306b\u6ec5\u83cc\u6587\u66f8\u3092\u540c\u68b1<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u5951\u7d04\u304a\u3088\u3073\u652f\u6255\u3044<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u67d4\u8edf\u306a\u652f\u6255\u6761\u4ef6\uff08T\/T\u3001L\/C \u306a\u3069\uff09<\/li>\n\n\n\n<li>\u88fd\u54c1\u4ed5\u69d8\u3068\u914d\u9001\u7d04\u675f\u3092\u542b\u3080\u6b63\u5f0f\u306a B2B \u5951\u7d04<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u751f\u7523\u3092\u958b\u59cb\u3057\u307e\u3059\u3002<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u81ea\u52d5\u5316\u30e9\u30a4\u30f3\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u3001\u30d0\u30c3\u30c1\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/li>\n\n\n\n<li>\u5305\u88c5\u524d\u306e\u54c1\u8cea\u7ba1\u7406\u30c1\u30a7\u30c3\u30af\u30dd\u30a4\u30f3\u30c8<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u30b0\u30ed\u30fc\u30d0\u30eb\u914d\u9001\u304a\u3088\u3073\u6587\u66f8<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u7a7a\u8def\u307e\u305f\u306f\u6d77\u8def\u306b\u3088\u308b\u4e16\u754c\u4e2d\u3078\u306e\u914d\u9001<\/li>\n\n\n\n<li>\u5b8c\u5168\u306a\u8f38\u9001\u66f8\u985e\uff1a\u8acb\u6c42\u66f8\u3001\u30d1\u30c3\u30ad\u30f3\u30b0\u30ea\u30b9\u30c8\u3001\u539f\u7523\u5730\u8a3c\u660e\u66f8\u3001\u304a\u3088\u3073\u88fd\u54c1\u8a3c\u660e\u66f8<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u30a2\u30d5\u30bf\u30fc\u30bb\u30fc\u30eb\u30b9\u30b5\u30dd\u30fc\u30c8<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u3059\u3079\u3066\u306e\u30d0\u30a4\u30e4\u30fc\u306b\u5bfe\u3059\u308b\u5c02\u4efb\u30a2\u30ab\u30a6\u30f3\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc<\/li>\n\n\n\n<li>\u82e6\u60c5\u89e3\u6c7a\u3001\u518d\u6ce8\u6587\u3001\u304a\u3088\u3073\u898f\u5236\u652f\u63f4<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"hanheng-s-b2b-buyer-support-highlights\">\ud83d\udcc8 \u6f22\u8861\u306eB2B\u30d0\u30a4\u30e4\u30fc\u30b5\u30dd\u30fc\u30c8\u306e\u30cf\u30a4\u30e9\u30a4\u30c8<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u6ce8\u6587\u8ffd\u8de1<\/li>\n\n\n\n<li>\u82f1\u8a9e\u3092\u8a71\u3059\u6280\u8853\u304a\u3088\u3073\u55b6\u696d\u30c1\u30fc\u30e0<\/li>\n\n\n\n<li>\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u304a\u3088\u3073\u30d7\u30ed\u30c8\u30bf\u30a4\u30d4\u30f3\u30b0\u306e\u8fc5\u901f\u306a\u5bfe\u5fdc<\/li>\n\n\n\n<li>EU\u3001\u7c73\u56fd\u3001\u305d\u306e\u4ed6\u306e\u5730\u57df\u306b\u5bfe\u3059\u308b\u898f\u5236\u652f\u63f4<\/li>\n<\/ul>\n\n\n\n<p>\ud83d\udca1 \u30d2\u30f3\u30c8\uff1a\u56fd\u5bb6\u5165\u672d\u5411\u3051\u307e\u305f\u306f\u75c5\u9662\u4f9b\u7d66\u5411\u3051\u306b\u6ce8\u6587\u3059\u308b\u5834\u5408\u3001\u88fd\u54c1\u306e\u66f8\u985e\u304c\u5730\u57df\u306e\u898f\u5236\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6f22\u8861\u306f\u30b9\u30e0\u30fc\u30ba\u306a\u8f38\u5165\u306e\u305f\u3081\u306eCE\u304a\u3088\u3073FDA\u66f8\u985e\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\ud83d\udce8 \u304a\u554f\u3044\u5408\u308f\u305b\uff1a <strong><a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><\/strong><br>\ud83c\udf10 \u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\uff1a <a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-2 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2248\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-HPV-ScreeningDouble-tips-Broom-tip-and-Nylon-Conical-cytobrush-tip-8313-4.jpg\" alt=\"\" class=\"wp-image-2248\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-HPV-ScreeningDouble-tips-Broom-tip-and-Nylon-Conical-cytobrush-tip-8313-4.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-HPV-ScreeningDouble-tips-Broom-tip-and-Nylon-Conical-cytobrush-tip-8313-4-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-HPV-ScreeningDouble-tips-Broom-tip-and-Nylon-Conical-cytobrush-tip-8313-4-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-HPV-ScreeningDouble-tips-Broom-tip-and-Nylon-Conical-cytobrush-tip-8313-4-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2218\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8306-2.jpg\" alt=\"\" class=\"wp-image-2218\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8306-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8306-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8306-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8306-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2216\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8305-2.jpg\" alt=\"\" class=\"wp-image-2216\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8305-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8305-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8305-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cervical-Scancer-Screening-CervixCervical-Brushboom-like-device-8305-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"8-faqs-iso-13485-certification-for-medical-device-buyers-distributors\">8. FAQ: \u533b\u7642\u6a5f\u5668\u30d0\u30a4\u30e4\u30fc\u304a\u3088\u3073\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u5411\u3051ISO 13485\u8a8d\u5b9a<\/h2>\n\n\n\n<p>B2B\u30d0\u30a4\u30e4\u30fc\u304c\u60c5\u5831\u306b\u57fa\u3065\u3044\u305f\u6c7a\u5b9a\u3092\u4e0b\u3059\u306e\u3092\u52a9\u3051\u308b\u305f\u3081\u3001\u3053\u3053\u306bISO 13485\u306b\u95a2\u9023\u3059\u308b\u6700\u3082\u983b\u7e41\u306b\u5c0b\u306d\u3089\u308c\u308b\u8cea\u554f\u3092\u6319\u3052\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-is-iso-13485-and-why-does-it-matter-for-medical-suppliers\">\u2753 ISO 13485\u3068\u306f\u4f55\u3067\u3001\u306a\u305c\u533b\u7642\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/h3>\n\n\n\n<p><strong>\u56de\u7b54<\/strong>\uff1aISO 13485\u306f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u304a\u3051\u308b\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u56fd\u969b\u898f\u683c\u3067\u3059\u3002\u88fd\u54c1\u304c\u898f\u5236\u304a\u3088\u3073\u5b89\u5168\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3088\u3046\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u306f\u3001\u88fd\u54c1\u304c\u53b3\u683c\u306a\u54c1\u8cea\u304a\u3088\u3073\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30b7\u30b9\u30c6\u30e0\u306e\u4e0b\u3067\u88fd\u9020\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"is-iso-13485-certification-required-to-sell-medical-devices-globally\">\u2753 ISO 13485\u8a8d\u8a3c\u306f\u533b\u7642\u6a5f\u5668\u3092\u30b0\u30ed\u30fc\u30d0\u30eb\u306b\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p><strong>\u56de\u7b54<\/strong>\uff1aISO 13485\u306f\u3059\u3079\u3066\u306e\u5834\u6240\u3067\u6cd5\u7684\u306b\u306f\u5fc5\u9808\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001EU\uff08MDR\u306e\u4e0b\uff09\u3084\u7c73\u56fd\uff08FDA\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u4e0b\uff09\u306a\u3069\u306e\u898f\u5236\u5e02\u5834\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b\u305f\u3081\u306b\u3057\u3070\u3057\u3070\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u591a\u304f\u306e\u75c5\u9662\u3084\u516c\u5171\u5165\u672d\u3082\u8abf\u9054\u306e\u305f\u3081\u306bISO\u8a8d\u8a3c\u88fd\u54c1\u3092\u8981\u6c42\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"how-do-i-verify-if-a-supplier-s-iso-13485-certificate-is-valid\">\u2753 \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306eISO 13485\u8a3c\u660e\u66f8\u304c\u6709\u52b9\u304b\u3069\u3046\u304b\u3092\u3069\u306e\u3088\u3046\u306b\u691c\u8a3c\u3057\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p><strong>\u56de\u7b54<\/strong>\uff1a\u8a3c\u660e\u66f8\u306e\u30b3\u30d4\u30fc\u3092\u6c42\u3081\u3001\u4ee5\u4e0b\u306e\u70b9\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3066\u304f\u3060\u3055\u3044\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u767a\u884c\u8a8d\u8a3c\u6a5f\u95a2\uff08\u4f8b\uff1aT\u00dcV\u3001SGS\uff09<\/li>\n\n\n\n<li>\u8a3c\u660e\u66f8\u306e\u6709\u52b9\u671f\u9650<\/li>\n\n\n\n<li>\u7bc4\u56f2\uff08\u95a2\u9023\u88fd\u54c1\u30bf\u30a4\u30d7\u306e\u751f\u7523\u307e\u305f\u306f\u4f9b\u7d66\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u308b\u3053\u3068\uff09<br>\u307e\u305f\u3001\u8a8d\u8a3c\u6a5f\u95a2\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3067\u691c\u8a3c\u3059\u308b\u304b\u3001\u76f4\u63a5\u9023\u7d61\u3092\u53d6\u308b\u3053\u3068\u3082\u3067\u304d\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"do-i-still-need-ce-or-fda-certification-if-the-supplier-has-iso-13485\">\u2753 \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304cISO 13485\u3092\u4fdd\u6709\u3057\u3066\u3044\u3066\u3082\u3001CE\u307e\u305f\u306fFDA\u8a8d\u8a3c\u306f\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p><strong>\u56de\u7b54<\/strong>\uff1a\u306f\u3044\u3002ISO 13485\u306fQMS\u898f\u683c\u3067\u3059\u304c\u3001CE\u30de\u30fc\u30af\u304a\u3088\u3073FDA\u627f\u8a8d\u306f\u88fd\u54c1\u56fa\u6709\u306e\u898f\u5236\u9075\u5b88\u3092\u793a\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u5b50\u5bae\u9838\u30d6\u30e9\u30b7\u306f\u751f\u7523\u54c1\u8cea\u306e\u70b9\u3067ISO 13485\u8a8d\u8a3c\u3092\u53d7\u3051\u3066\u3044\u3066\u3082\u3001EU\u3067\u8ca9\u58f2\u3059\u308b\u306b\u306fCE\u30de\u30fc\u30af\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-s-the-difference-between-iso-9001-and-iso-13485\">\u2753 ISO 9001\u3068ISO 13485\u306e\u9055\u3044\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u7279\u5fb4<\/th><th>ISO 9001<\/th><th>ISO 13485<\/th><\/tr><\/thead><tbody><tr><td>\u7bc4\u56f2<\/td><td>\u5168\u7523\u696d\u5411\u3051\u306e\u4e00\u822c\u7684\u306aQMS<\/td><td>\u533b\u7642\u6a5f\u5668\u5c02\u7528\u306eQMS<\/td><\/tr><tr><td>\u898f\u5236\u3078\u306e\u9069\u5408<\/td><td>\u898f\u5236\u7528\u9014\u5411\u3051\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u306a\u3044<\/td><td>\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u533b\u7642\u898f\u5236\u3092\u6e80\u305f\u3059\u3088\u3046\u8a2d\u8a08<\/td><\/tr><tr><td>\u30ea\u30b9\u30af\u7ba1\u7406<\/td><td>\u5b50\u5bae\u9838\u304c\u3093\u691c\u8a3a\u30d7\u30ed\u30b0\u30e9\u30e0<\/td><td>\u5305\u62ec\u7684<\/td><\/tr><tr><td>\u88fd\u54c1\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/td><td>\u57fa\u672c<\/td><td>\u53b3\u683c\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u304c\u5fc5\u8981<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-kind-of-products-does-hanheng-offer-under-iso-13485\">\u2753 \u6f22\u8861\u306fISO 13485\u306e\u4e0b\u3067\u3069\u306e\u3088\u3046\u306a\u88fd\u54c1\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p><strong>\u56de\u7b54<\/strong>\uff1a\u6c5f\u8607\u6f22\u8861\u306f\u3001ISO 13485\u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u5e45\u5e83\u3044\u533b\u7642\u6d88\u8017\u54c1\u3092\u88fd\u9020\u3057\u3066\u304a\u308a\u3001\u4ee5\u4e0b\u3092\u542b\u307f\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9f3b\u54bd\u982d\u304a\u3088\u3073\u54bd\u982d\u30b9\u30ef\u30d6<\/li>\n\n\n\n<li>\u4f7f\u3044\u6368\u3066\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30eb\u30b3\u30ec\u30af\u30bf\u30fc<\/li>\n\n\n\n<li>\u6ec5\u83cc\u5a66\u4eba\u79d1\u30d6\u30e9\u30b7<\/li>\n\n\n\n<li>\u81a3\u30b9\u30af\u30e9\u30c3\u30d1\u30fc\u3068\u30ad\u30c3\u30c8<\/li>\n\n\n\n<li>\u30ab\u30b9\u30bf\u30e0\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30dc\u30c3\u30af\u30b9<\/li>\n<\/ul>\n\n\n\n<p>\u3059\u3079\u3066\u306e\u88fd\u54c1\u306f\u8a8d\u8a3c\u3055\u308c\u305f\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u74b0\u5883\u3067\u88fd\u9020\u3055\u308c\u3001FDA\u304a\u3088\u3073CE\u57fa\u6e96\u3092\u6e80\u305f\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"can-i-request-a-product-sample-from-hanheng-before-placing-a-bulk-order\">\u2753 \u5927\u91cf\u6ce8\u6587\u524d\u306b\u6f22\u8861\u304b\u3089\u88fd\u54c1\u30b5\u30f3\u30d7\u30eb\u3092\u30ea\u30af\u30a8\u30b9\u30c8\u3067\u304d\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p><strong>\u56de\u7b54<\/strong>\uff1a\u3082\u3061\u308d\u3093\u3067\u3059\u3002\u6f22\u8861\u306fB2B\u30d0\u30a4\u30e4\u30fc\u304c\u30b5\u30f3\u30d7\u30eb\u3092\u901a\u3058\u3066\u88fd\u54c1\u54c1\u8cea\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3092\u5968\u52b1\u3057\u307e\u3059\u3002\u30b5\u30f3\u30d7\u30eb\u306b\u306f\u5b8c\u5168\u306a\u66f8\u985e\u3068\u6ec5\u83cc\u8a3c\u660e\u66f8\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"how-long-does-it-take-to-receive-a-bulk-order\">\u2753 \u5927\u91cf\u6ce8\u6587\u306e\u53d7\u3051\u53d6\u308a\u306b\u306f\u3069\u306e\u304f\u3089\u3044\u6642\u9593\u304c\u304b\u304b\u308a\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p><strong>\u56de\u7b54<\/strong>\uff1a\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0\u306f\u6ce8\u6587\u91cf\u3068\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u304c\u3001\u6f22\u8861\u306f\u901a\u5e3815\u301c30\u55b6\u696d\u65e5\u4ee5\u5185\u306b\u767a\u9001\u3057\u307e\u3059\u3002\u7dca\u6025\u6ce8\u6587\u306f\u30ea\u30af\u30a8\u30b9\u30c8\u306b\u3088\u308a\u8fc5\u901f\u5316\u53ef\u80fd\u3067\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-makes-hanheng-a-top-choice-for-iso-13485-medical-consumables\">\u2753 \u6f22\u8861\u3092ISO 13485\u533b\u7642\u6d88\u8017\u54c1\u306e\u30c8\u30c3\u30d7\u9078\u629e\u3068\u3059\u308b\u3082\u306e\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p><strong>\u56de\u7b54<\/strong>\uff1a\u6f22\u8861\u306f\u4ee5\u4e0b\u306e\u5e0c\u5c11\u306a\u7d44\u307f\u5408\u308f\u305b\u3092\u63d0\u4f9b\u3057\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 13485\u6e96\u62e0<\/li>\n\n\n\n<li>CE\/FDA\u627f\u8a8d\u88fd\u54c1<\/li>\n\n\n\n<li>\u9ad8\u5bb9\u91cf\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u751f\u7523<\/li>\n\n\n\n<li>R&amp;D\u4e3b\u5c0e\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3<\/li>\n\n\n\n<li>\u30b0\u30ed\u30fc\u30d0\u30ebB2B\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u5411\u3051\u306e\u512a\u308c\u305f\u30a2\u30d5\u30bf\u30fc\u30bb\u30fc\u30eb\u30b9\u30b5\u30dd\u30fc\u30c8<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"9-conclusion-call-to-action-partnering-with-certified-medical-suppliers-for-long-term-success\">9. \u7d50\u8ad6\u3068\u884c\u52d5\u559a\u8d77: \u8a8d\u5b9a\u533b\u7642\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u306e\u9577\u671f\u7684\u306a\u6210\u529f\u306e\u305f\u3081\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7<\/h2>\n\n\n\n<p>\u7cbe\u5bc6\u6027\u3001\u5b89\u5168\u6027\u3001\u304a\u3088\u3073\u9075\u5b88\u3092\u6c42\u3081\u308b\u533b\u7642\u696d\u754c\u306b\u304a\u3044\u3066\u3001ISO 13485\u8a8d\u8a3c\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u306e\u8abf\u9054\u306f\u3082\u306f\u3084\u30aa\u30d7\u30b7\u30e7\u30f3\u3067\u306f\u306a\u304f\u3001\u5fc5\u8981\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u533b\u7642\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u3001\u75c5\u9662\u8abf\u9054\u62c5\u5f53\u8005\u3001\u307e\u305f\u306f\u30b0\u30ed\u30fc\u30d0\u30eb\u30bd\u30fc\u30b7\u30f3\u30b0\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u306e\u3044\u305a\u308c\u3067\u3042\u3063\u3066\u3082\u3001\u8a8d\u8a3c\u30e1\u30fc\u30ab\u30fc\u3068\u306e\u5354\u529b\u306f\u4ee5\u4e0b\u3092\u4fdd\u8a3c\u3057\u307e\u3059\uff1a<\/p>\n\n\n\n<p>\u2705 \u4e00\u8cab\u3057\u305f\u88fd\u54c1\u54c1\u8cea<br>\u2705 \u898f\u5236\u5e02\u5834\u30a2\u30af\u30bb\u30b9<br>\u2705 \u30ea\u30b9\u30af\u8efd\u6e1b<br>\u2705 \u9577\u671f\u7684\u306a\u30d3\u30b8\u30cd\u30b9\u4fe1\u983c\u6027<\/p>\n\n\n\n<p>\u30b0\u30ed\u30fc\u30d0\u30eb\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u4e2d\u3067\u3001 <strong><a href=\"https:\/\/hanheng-medical.com\/ja\/contact-us\/\">\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8<\/a><\/strong> \u306f\u3001\u4e2d\u56fd\u3067\u6700\u3082\u4fe1\u983c\u3055\u308c\u308bISO 13485\u8a8d\u8a3c\u533b\u7642\u691c\u67fb\u6d88\u8017\u54c1\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u969b\u7acb\u3063\u3066\u3044\u307e\u3059\u3002R&amp;D\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u3001\u304a\u3088\u3073\u898f\u5236\u627f\u8a8d\u306b\u304a\u3051\u308b\u5f37\u56fa\u306a\u57fa\u76e4\u3092\u5099\u3048\u3001\u6f22\u8861\u306f\u4ee5\u4e0b\u306e\u7406\u60f3\u7684\u306aB2B\u30d1\u30fc\u30c8\u30ca\u30fc\u3067\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u75c5\u9662\u306e\u8abf\u9054\u90e8\u9580<\/li>\n\n\n\n<li>\u533b\u7642\u7528\u8ca9\u58f2\u696d\u8005\u304a\u3088\u3073\u5378\u58f2\u696d\u8005<\/li>\n\n\n\n<li>\u4fdd\u5065\u6a5f\u95a2\u304a\u3088\u3073\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u30d7\u30ed\u30b0\u30e9\u30e0<\/li>\n\n\n\n<li>E\u30b3\u30de\u30fc\u30b9\u533b\u7642\u4f9b\u7d66\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/li>\n<\/ul>\n\n\n\n<p>\ud83d\udcde \u30bd\u30fc\u30b7\u30f3\u30b0\u6226\u7565\u3092\u5411\u4e0a\u3055\u305b\u308b\u6e96\u5099\u306f\u3067\u304d\u307e\u3057\u305f\u304b\uff1f<\/p>\n\n\n\n<p>\ud83d\udda5 \u8a2a\u554f\uff1a <a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><br>\ud83d\udce9 \u30e1\u30fc\u30eb\uff1a <strong><a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><\/strong> \u88fd\u54c1\u30ab\u30bf\u30ed\u30b0\u3001ISO\u66f8\u985e\u3001\u304a\u3088\u3073\u4fa1\u683c\u306e\u305f\u3081\u306b\u3002<\/p>\n\n\n\n<p>\u6f22\u8861\u3067\u3088\u308a\u30b9\u30de\u30fc\u30c8\u3067\u5b89\u5168\u306a\u8a8d\u5b9a\u533b\u7642\u6d88\u8017\u54c1\u306e\u8abf\u9054\u306e\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u8e0f\u307f\u51fa\u3057\u307e\u3057\u3087\u3046 \u2014 \u3053\u3053\u3067\u306f\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u304c\u51fa\u4f1a\u3046\u9075\u5b88\u3067\u3059\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>1. \u5c0e\u5165: \u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3051\u308bISO 13485\u306e\u91cd\u8981\u306a\u5f79\u5272 \u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u304a\u3088\u3073\u6d41\u901a\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u72b6\u6cc1\u306b\u304a\u3044\u3066\u3001ISO 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