{"id":1656,"date":"2021-03-11T18:19:33","date_gmt":"2021-03-11T18:19:33","guid":{"rendered":"http:\/\/www.validant.com\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8\/"},"modified":"2021-04-14T20:52:38","modified_gmt":"2021-04-14T20:52:38","slug":"%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8","status":"publish","type":"page","link":"https:\/\/www.validant.com\/ja\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668"},"content":{"rendered":"\n<section class=\"wp-block-mkl-section-block\"><div class=\"section-bg bg__stretched\" style=\"background-image:url(https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/medical-device-header-img.jpg);opacity:1\"><\/div>\n<div class=\"wp-block-mkl-section-block container pt-xl\">\n<p><\/p>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block transparent\">\n<div class=\"wp-block-mkl-section-block has-white-background-color container panel ot-l\">\n<h1 class=\"has-text-align-center pt-xxs wp-block-heading\"><strong><span class=\"has-inline-color has-green-color\">\u533b\u7642\u6a5f\u5668<\/span><\/strong>\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u30b5\u30fc\u30d3\u30b9<\/h1>\n\n\n\n<p class=\"has-text-align-center maxc1000 pt-xxs\">\u533b\u7642\u6a5f\u5668\u5206\u91ce\u306e\u9769\u65b0\u304c\u52a0\u901f\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u88fd\u54c1\u958b\u767a\u3068\u5546\u54c1\u5316\u306b\u3064\u3044\u3066\u3001\u6cd5\u4ee4\u3092\u9075\u5b88\u3057\u3001\u73fe\u5b9f\u7684\u3067\u88fd\u54c1\u54c1\u8cea\u3092\u7d99\u7d9a\u7684\u306b\u5411\u4e0a\u3055\u305b\u308b\u78ba\u56fa\u306a\u6226\u7565\u3092\u3082\u3064\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<strong>Validant\u304c\u9078\u3070\u308c\u308b\u7406\u7531\u306f\uff1f<\/strong><\/p>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block\">\n<div class=\"wp-block-mkl-section-block container pt-xxs pb-xxs\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"300\" src=\"http:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/medical-devices-quality-compliance.jpg\" alt=\"&#x533B;&#x7642;&#x6A5F;&#x5668;&#x30B3;&#x30F3;&#x30B5;&#x30EB;&#x30C6;&#x30A3;&#x30F3;&#x30B0;&#x30B5;&#x30FC;&#x30D3;&#x30B9;\" class=\"wp-image-1561\" srcset=\"https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/medical-devices-quality-compliance.jpg 500w, https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/medical-devices-quality-compliance-300x180.jpg 300w\" sizes=\"auto, (max-width: 500px) 100vw, 500px\" \/><\/figure>\n\n\n<div class=\"wp-block-group has-white-background-color has-background pt-xs ot-s z1 mr-m\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<h3 class=\"has-green-color has-text-color icon icon-lifecycle mb-z wp-block-heading\"><strong>\u5358\u4e00\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u4f01\u696d\u304b\u3089\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30b5\u30dd\u30fc\u30c8<\/strong><\/h3>\n\n\n\n<p class=\"max500\">\u30af\u30e9\u30b9I\u3001II\u3001III\u306e\u533b\u7642\u6a5f\u5668\u3092\u4e0a\u5e02\u3057\u3001\u5b89\u5168\u3067\u4fe1\u983c\u6027\u306e\u3042\u308b\u30a2\u30af\u30bb\u30b9\u3092\u78ba\u4fdd\u3067\u304d\u308b\u3088\u3046\u306b\u3001Validant\u306f\u6226\u7565\u3001\u5b9f\u884c\u3001\u30b5\u30dd\u30fc\u30c8\u306e\u30b5\u30fc\u30d3\u30b9\u3092\u5305\u62ec\u7684\u306b\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u6b21\u306e\u9805\u76ee\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u85ac\u4e8b\u6226\u7565<\/li><li>\u884c\u653f\u6a5f\u95a2\u3078\u306e\u7533\u8acb<\/li><li>\u67fb\u5bdf\u3078\u306e\u5bfe\u5fdc\u6e96\u5099\u3068\u30b5\u30dd\u30fc\u30c8<\/li><li>\u51fa\u9858\u304a\u3088\u3073\u767b\u9332<\/li><li>\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/li><li>GMP (\u533b\u85ac\u54c1\u7b49\u306e\u88fd\u9020\u54c1\u8cea\u7ba1\u7406\u57fa\u6e96)\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/li><li>\u4e0a\u5e02\u5f8c\u8abf\u67fb<\/li><li>\u4fdd\u5065\u5f53\u5c40\u306e\u57f7\u884c\u306b\u5bfe\u3059\u308b\u5bfe\u5fdc\u3068\u662f\u6b63<\/li><\/ul><\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"300\" src=\"http:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/medical-device-end-to-end-consulting.jpg\" alt=\"&#x533B;&#x7642;&#x6A5F;&#x5668;&#x306E;&#x5305;&#x62EC;&#x30B3;&#x30F3;&#x30B5;&#x30EB;&#x30C6;&#x30A3;&#x30F3;&#x30B0;\" class=\"wp-image-1563\" srcset=\"https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/medical-device-end-to-end-consulting.jpg 500w, https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/medical-device-end-to-end-consulting-300x180.jpg 300w\" sizes=\"auto, (max-width: 500px) 100vw, 500px\" \/><\/figure>\n\n\n<div class=\"wp-block-group has-white-background-color has-background pt-xs ot-s z1 mr-m\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<h3 class=\"has-green-color has-text-color icon icon-specialty mb-z wp-block-heading\"><strong><strong>\u54c1\u8cea\u7ba1\u7406\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6700\u9069\u5316<\/strong><\/strong><\/h3>\n\n\n\n<p class=\"max500\">Validant\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\/\u88fd\u9020\u4f01\u696d\u306b\u9069\u7528\u3055\u308c\u308b\u3001\u7d30\u304b\u304f\u7570\u306a\u308b\u6cd5\u898f\u5236\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3067\u3042\u308a\u3001\u304a\u5ba2\u69d8\u304c\u6b21\u306e\u624b\u7d9a\u304d\u3092\u9032\u3081\u308b\u4e0a\u3067\u5b9f\u52d9\u7684\u306a\u30b5\u30dd\u30fc\u30c8\u3068\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u884c\u653f\u6a5f\u95a2\u3078\u306e\u7533\u8acb: 510(k)\u3001PMA\u3001De Novo<\/li><li>\u4e8b\u524d\u7533\u8acb: IDE\u3001HDE\u3001HUD\u3001\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb<\/li><li>ISO 13485<\/li><li>ISO 14971<\/li><li>21 CFR Part 820<\/li><li>EU MDR \/ IVDR<\/li><\/ul><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block cta-panel mt-z mb-m\">\n<div class=\"wp-block-mkl-section-block container panel bg-greengrad\">\n<div class=\"wp-block-mkl-section-block has-green-background-color bg-greengrad panel\">\n<p><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-columns relative is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<h2 class=\"has-white-color has-text-color wp-block-heading\">\u3069\u306e\u3088\u3046\u306a<strong><span class=\"has-inline-color has-lightblue-color\">\u5f53\u793e\u306e\u30b5\u30fc\u30d3\u30b9<br\/><\/span><\/strong>\u304c\u3054\u5e0c\u671b\u3067\u3059\u304b\uff1f<\/h2>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"has-text-color has-white-color 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