{"id":4345,"date":"2024-12-17T11:28:58","date_gmt":"2024-12-17T02:28:58","guid":{"rendered":"https:\/\/drgemhealthcare.com\/?p=4345"},"modified":"2025-06-27T16:12:14","modified_gmt":"2025-06-27T07:12:14","slug":"drgem-achieves-mdsap-certification-accelerating-global-expansion","status":"publish","type":"post","link":"https:\/\/www.drgemhealthcare.com\/ja\/drgem-achieves-mdsap-certification-accelerating-global-expansion\/","title":{"rendered":"DRGEM\u304cMDSAP\u8a8d\u8a3c\u3092\u53d6\u5f97\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u5c55\u958b\u3092\u52a0\u901f"},"content":{"rendered":"<figure class=\"wp-block-image aligncenter size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/drgemhealthcare.com\/wp-content\/uploads\/2024\/12\/image-4.png\" alt=\"\" class=\"wp-image-4446\" srcset=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2024\/12\/image-4.png 1000w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2024\/12\/image-4-300x165.png 300w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2024\/12\/image-4-768x422.png 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"translation-block\">\u533b\u7642\u7528X\u7dda\u88c5\u7f6e\u306e\u5927\u624b\u30e1\u30fc\u30ab\u30fc\u3067\u3042\u308bDRGEM\u306f\u4eca\u6708\u3001<strong>Medical Device Single Audit Program (MDSAP)<\/strong>\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3001\u91cd\u8981\u306a\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u3092\u9054\u6210\u3057\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>MDSAP\u306f\u30015\u3064\u306e\u4e3b\u8981\u5e02\u5834\u306b\u304a\u3051\u308b\u898f\u5236\u8981\u4ef6\u3078\u306e\u9069\u5408\u3092\u8a3c\u660e\u3059\u308b\u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u8a8d\u8a3c\u3067\u3042\u308b\uff1a\u30ab\u30ca\u30c0\u3001\u7c73\u56fd\u3001\u65e5\u672c\u3001\u30d6\u30e9\u30b8\u30eb\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<p>ISO13485:2016\u898f\u683c\u306b\u57fa\u3065\u3044\u3066\u69cb\u7bc9\u3055\u308c\u305fMDSAP\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u53c2\u52a05\u30ab\u56fd\u3059\u3079\u3066\u3067\u5358\u4e00\u306e\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u3092\u901a\u3058\u3066\u898f\u5236\u9075\u5b88\u3092\u5408\u7406\u5316\u3059\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3059\u308b\u3002<\/p>\n\n\n\n<p>MDSAP\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u305f\u3053\u3068\u3067\u3001\u540c\u793e\u306f\u5e02\u5834\u62e1\u5927\u306b\u3055\u3089\u306b\u5f3e\u307f\u304c\u3064\u304f\u3068\u898b\u8fbc\u3093\u3067\u3044\u308b\u3002<\/p>\n\n\n\n<p>\u300c\u3053\u306e\u8a8d\u8a3c\u306f\u3001DRGEM\u304c\u4e16\u754c\u30af\u30e9\u30b9\u306e\u54c1\u8cea\u57fa\u6e96\u3092\u7dad\u6301\u3057\u3001\u88fd\u9020\u65bd\u8a2d\u3092\u542b\u3080\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u5353\u8d8a\u3057\u305f\u904b\u7528\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u306b\u5c02\u5ff5\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u3059\u300d\u3068\u3001\u54c1\u8cea\u7ba1\u7406\u90e8\u9580\u306e\u30c1\u30fc\u30d5\u3067\u3042\u308bSung-Hee Park\u6c0f\u306f\u8ff0\u3079\u305f\u3002<\/p>\n\n\n\n<p>\u300c\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u8ca9\u58f2\u30d1\u30fc\u30c8\u30ca\u30fc\u306b\u3001\u5f53\u793e\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u80fd\u529b\u3092\u3055\u3089\u306b\u4fdd\u8a3c\u3067\u304d\u308b\u3053\u3068\u3092\u3046\u308c\u3057\u304f\u601d\u3046\u3002<\/p>\n\n\n\n<p>\u88fd\u54c1\u306e\u5353\u8d8a\u6027\u3001\u4f7f\u3044\u3084\u3059\u3055\u3001\u7af6\u4e89\u529b\u306e\u3042\u308b\u4fa1\u683c\u8a2d\u5b9a\u306b\u6ce8\u529b\u3059\u308b\u3053\u3068\u3067\u3001DRGEM\u306f\u4e16\u754c\u306e\u533b\u7642\u7528\u753b\u50cf\u51e6\u7406\u696d\u754c\u3067\u4fe1\u983c\u3055\u308c\u308b\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u3057\u3066\u306e\u5b58\u5728\u611f\u3092\u78ba\u56fa\u305f\u308b\u3082\u306e\u306b\u3059\u308b\u3053\u3068\u3092\u76ee\u6307\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p>\u3000<\/p>","protected":false},"excerpt":{"rendered":"<p>DRGEM, a leading manufacturer of medical X-ray equipment, achieved a significant milestone this month by obtaining the&nbsp;Medical Device Single Audit Program (MDSAP) certification. The MDSAP is an internationally recognized certification that demonstrates compliance with regulatory requirements in five major markets: Canada, the United States, Japan, Brazil, and Australia. Built on the ISO 13485:2016 standard, MDSAP enables medical device manufacturers to streamline regulatory compliance through a single audit process in all five participating countries. With the acquisition of MDSAP certification, the company anticipates gaining further momentum in its market expansion. \u201cThis certification validates DRGEM\u2019s dedication to maintaining world-class quality standards and ensuring operational excellence in its quality management system including manufacturing [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":8027,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[14],"tags":[],"class_list":["post-4345","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drgem-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>DRGEM Achieves MDSAP Certification, Accelerating Global Expansion - DRGEM<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.drgemhealthcare.com\/ja\/drgem-achieves-mdsap-certification-accelerating-global-expansion\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DRGEM Achieves MDSAP Certification, Accelerating Global Expansion\" \/>\n<meta property=\"og:description\" content=\"DRGEM, a leading manufacturer of medical X-ray equipment, achieved a significant milestone this month by obtaining the&nbsp;Medical Device Single Audit Program (MDSAP) certification. The MDSAP is an internationally recognized certification that demonstrates compliance with regulatory requirements in five major markets: Canada, the United States, Japan, Brazil, and Australia. Built on the ISO 13485:2016 standard, MDSAP enables medical device manufacturers to streamline regulatory compliance through a single audit process in all five participating countries. With the acquisition of MDSAP certification, the company anticipates gaining further momentum in its market expansion. \u201cThis certification validates DRGEM\u2019s dedication to maintaining world-class quality standards and ensuring operational excellence in its quality management system including manufacturing [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.drgemhealthcare.com\/ja\/drgem-achieves-mdsap-certification-accelerating-global-expansion\/\" \/>\n<meta property=\"og:site_name\" content=\"DRGEM\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/drgemglobal\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-17T02:28:58+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-27T07:12:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2024\/03\/MDSAP_thum.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"600\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"inakim\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@drgemhealthcare\" \/>\n<meta name=\"twitter:site\" content=\"@drgemhealthcare\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"inakim\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.drgemhealthcare.com\/drgem-achieves-mdsap-certification-accelerating-global-expansion\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.drgemhealthcare.com\/drgem-achieves-mdsap-certification-accelerating-global-expansion\/\"},\"author\":{\"name\":\"inakim\",\"@id\":\"https:\/\/www.drgemhealthcare.com\/#\/schema\/person\/2b23215d0a32c9595f22bb8b6078c574\"},\"headline\":\"DRGEM Achieves MDSAP Certification, Accelerating Global Expansion\",\"datePublished\":\"2024-12-17T02:28:58+00:00\",\"dateModified\":\"2025-06-27T07:12:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.drgemhealthcare.com\/drgem-achieves-mdsap-certification-accelerating-global-expansion\/\"},\"wordCount\":173,\"publisher\":{\"@id\":\"https:\/\/www.drgemhealthcare.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.drgemhealthcare.com\/drgem-achieves-mdsap-certification-accelerating-global-expansion\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2024\/03\/MDSAP_thum.jpg\",\"articleSection\":[\"DRGEM News\"],\"inLanguage\":\"ja\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.drgemhealthcare.com\/drgem-achieves-mdsap-certification-accelerating-global-expansion\/\",\"url\":\"https:\/\/www.drgemhealthcare.com\/drgem-achieves-mdsap-certification-accelerating-global-expansion\/\",\"name\":\"DRGEM Achieves MDSAP Certification, Accelerating Global Expansion - 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