{"id":33877,"date":"2026-02-10T02:27:26","date_gmt":"2026-02-10T02:27:26","guid":{"rendered":"https:\/\/www.globalresearch.co.kr\/insight\/medical-device-testing-and-certification-market-mordor\/"},"modified":"2026-09-11T04:32:10","modified_gmt":"2026-09-10T19:32:10","slug":"medical-device-testing-and-certification-market-mordor","status":"publish","type":"post","link":"https:\/\/www.globalresearch.co.kr\/insight\/medical-device-testing-and-certification-market-mordor\/","title":{"rendered":"\uc138\uacc4\uc758 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc810\uc720\uc728 \ubd84\uc11d &#8211; \uc131\uc7a5 \ub3d9\ud5a5 \ubc0f \uc804\ub9dd (2026-2031\ub144)"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/www.globalresearch.co.kr\/insight\/wp-content\/uploads\/2026\/02\/medical-device-testing-and-certification-market-1730905259574-Key-Players-Logo-Medical-Device-Testing-and-Certification-Market.webp\" alt=\"Chart\" class=\"aligncenter size-full\" \/><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/www.globalresearch.co.kr\/insight\/wp-content\/uploads\/2026\/02\/medical-device-testing-and-certification-market-size-image-1768932676028.webp\" alt=\"Chart\" class=\"aligncenter size-full\" \/><\/p>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-0\">\n    1. \uc11c\ub860<\/p>\n<ul>\n<li class=\"toc-level-2\">\n          1.1 \uc5f0\uad6c \uac00\uc815 &amp; \uc2dc\uc7a5 \uc815\uc758<\/p>\n<\/li>\n<li class=\"toc-level-2\">\n          1.2 \uc5f0\uad6c \ubc94\uc704<\/p>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-1\">\n    2. \uc5f0\uad6c \ubc29\ubc95\ub860<\/p>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-2\">\n    3. \uc694\uc57d<\/p>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-3\">\n    4. \uc2dc\uc7a5 \ud658\uacbd<\/p>\n<ul>\n<li class=\"toc-level-2\">\n          4.1 \uc2dc\uc7a5 \uac1c\uc694<\/p>\n<\/li>\n<li class=\"toc-level-2\">\n          4.2 \uc2dc\uc7a5 \ub3d9\uc778<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          4.2.1 EU MDR \ubc0f FDA \uc548\uc804 \uc7a5\uce58\ubc95\uc5d0 \ub530\ub978 \uaddc\uc81c \uac15\ud654<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.2 AI\/ML \uc9c0\uc6d0 \uc7a5\uce58 \uc99d\uac00\ub85c \uc778\ud55c \uc804\ubb38 \uac80\uc99d \ud544\uc694\uc131 \uc99d\ub300<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.3 \uac00\uc815\uc6a9 \ubc0f \uc6e8\uc5b4\ub7ec\ube14 \uc9c4\ub2e8 \uae30\uae30 \uc131\uc7a5\uc5d0 \ub530\ub978 \ud14c\uc2a4\ud2b8 \ubb3c\ub7c9 \ud655\ub300<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.4 \ud544\uc218 \uc0ac\uc774\ubc84 \ubcf4\uc548 \uc2dc\uc7a5 \ucd9c\uc2dc \uc804 \uc81c\ucd9c (FDA 2024)<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.5 ESG \uae30\ubc18 \uc9c0\uc18d \uac00\ub2a5\uc131 \uac10\uc0ac\uac00 \uc870\ub2ec \uae30\uc900\uc774 \ub428<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.6 \uc0dd\uccb4 \uc758\ud559 \uae30\uc220 \uc778\ub825\uc758 \uae30\uc220 \uaca9\ucc28 \uc778\uc99d<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          4.3 \uc2dc\uc7a5 \uc81c\uc57d<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          4.3.1 \uacf5\uc778 \uae30\uad00\uc758 \uc81c\ud55c\ub41c \uc5ed\ub7c9 &amp; \uae34 \ub9ac\ub4dc \ud0c0\uc784<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.3.2 \uc911\uc18c\uae30\uc5c5 &amp; \uc2a4\ud0c0\ud2b8\uc5c5\uc758 \ub192\uc740 \ud14c\uc2a4\ud2b8 \ube44\uc6a9<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.3.3 AI \uc54c\uace0\ub9ac\uc998 \uac80\uc99d\uc744 \uc704\ud55c \ud45c\uc900\ud654\ub41c \ub370\uc774\ud130 \uc138\ud2b8 \ubd80\uc871<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.3.4 \ud30c\ud3b8\ud654\ub41c \uc9c0\uc18d \uac00\ub2a5\uc131 \uaddc\uc815 \uc900\uc218 \uc694\uad6c \uc0ac\ud56d<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          4.4 \uac00\uce58 \/ \uacf5\uae09\ub9dd \ubd84\uc11d<\/p>\n<\/li>\n<li class=\"toc-level-2\">\n          4.5 \uaddc\uc81c \ud658\uacbd<\/p>\n<\/li>\n<li class=\"toc-level-2\">\n          4.6 \uae30\uc220 \uc804\ub9dd<\/p>\n<\/li>\n<li class=\"toc-level-2\">\n          4.7 \ud3ec\ud130\uc758 5\uac00\uc9c0 \uacbd\uc7c1 \uc694\uc778<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          4.7.1 \uc2e0\uaddc \uc9c4\uc785\uc790\uc758 \uc704\ud611<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.7.2 \uacf5\uae09\uc5c5\uccb4\uc758 \uad50\uc12d\ub825<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.7.3 \uad6c\ub9e4\uc790\uc758 \uad50\uc12d\ub825<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.7.4 \ub300\uccb4\uc7ac\uc758 \uc704\ud611<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.7.5 \uacbd\uc7c1 \uac15\ub3c4<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-4\">\n    5. \uc2dc\uc7a5 \uaddc\ubaa8 &amp; \uc131\uc7a5 \uc608\uce21 (\uac00\uce58, USD)<\/p>\n<ul>\n<li class=\"toc-level-2\">\n          5.1 \uc11c\ube44\uc2a4 \uc720\ud615\ubcc4<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          5.1.1 \ud14c\uc2a4\ud2b8 \uc11c\ube44\uc2a4<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.1.2 \uc778\uc99d \uc11c\ube44\uc2a4<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.1.3 \uac80\uc0ac &amp; \uac10\uc0ac \uc11c\ube44\uc2a4<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.1.4 \uae30\ud0c0<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          5.2 \uae30\uae30 \ub4f1\uae09\ubcc4<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          5.2.1 \ud074\ub798\uc2a4 I<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.2.2 \ud074\ub798\uc2a4 II<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.2.3 \ud074\ub798\uc2a4 III<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.2.4 \uccb4\uc678 \uc9c4\ub2e8 \uae30\uae30<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          5.3 \ud14c\uc2a4\ud2b8 \uc720\ud615\ubcc4<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          5.3.1 \uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.3.2 \uba78\uade0 &amp; \ubbf8\uc0dd\ubb3c \ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.3.3 \uc804\uae30 \uc548\uc804 &amp; EMC<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.3.4 \uc18c\ud504\ud2b8\uc6e8\uc5b4 &amp; \uc0ac\uc774\ubc84 \ubcf4\uc548 \ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.3.5 \uae30\uacc4 &amp; \ubb3c\ub9ac\uc801 \ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.3.6 \ud3ec\uc7a5 &amp; \uc720\ud1b5 \uae30\ud55c \ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          5.4 \uc9c0\uc5ed\ubcc4<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          5.4.1 \ubd81\ubbf8<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.1.1 \ubbf8\uad6d<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.1.2 \uce90\ub098\ub2e4<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.1.3 \uba55\uc2dc\ucf54<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.4.2 \uc720\ub7fd<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.2.1 \ub3c5\uc77c<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.2.2 \uc601\uad6d<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.2.3 \ud504\ub791\uc2a4<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.2.4 \uc774\ud0c8\ub9ac\uc544<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.2.5 \uc2a4\ud398\uc778<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.2.6 \uae30\ud0c0 \uc720\ub7fd<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.4.3 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.3.1 \uc911\uad6d<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.3.2 \uc778\ub3c4<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.3.3 \uc77c\ubcf8<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.3.4 \ub300\ud55c\ubbfc\uad6d<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.3.5 \ud638\uc8fc<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.3.6 \uae30\ud0c0 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.4.4 \ub0a8\ubbf8<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.4.1 \ube0c\ub77c\uc9c8<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.4.2 \uc544\ub974\ud5e8\ud2f0\ub098<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.4.3 \uae30\ud0c0 \ub0a8\ubbf8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.4.5 \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.5.1 GCC<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.5.2 \ub0a8\uc544\ud504\ub9ac\uce74<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.4.5.3 \uae30\ud0c0 \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-5\">\n    6. \uacbd\uc7c1 \ud658\uacbd<\/p>\n<ul>\n<li class=\"toc-level-2\">\n          6.1 \uc2dc\uc7a5 \uc9d1\uc911\ub3c4<\/p>\n<\/li>\n<li class=\"toc-level-2\">\n          6.2 \uc2dc\uc7a5 \uc810\uc720\uc728 \ubd84\uc11d<\/p>\n<\/li>\n<li class=\"toc-level-2\">\n          6.3 \uae30\uc5c5 \ud504\ub85c\ud544 (\uae00\ub85c\ubc8c \uac1c\uc694, \uc2dc\uc7a5 \uac1c\uc694, \ud575\uc2ec \ubd80\ubb38, \uc7ac\ubb34 \uc815\ubcf4(\uc0ac\uc6a9 \uac00\ub2a5\ud55c \uacbd\uc6b0), \uc804\ub7b5 \uc815\ubcf4, \uc8fc\uc694 \uae30\uc5c5\uc758 \uc2dc\uc7a5 \uc21c\uc704\/\uc810\uc720\uc728, \uc81c\ud488 &amp; \uc11c\ube44\uc2a4, \ucd5c\uadfc \uac1c\ubc1c \ud3ec\ud568)<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          6.3.1 SGS SA<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.2 Intertek Group plc<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.3 T\u00dcV S\u00dcD<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.4 UL Solutions<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.5 Eurofins Scientific<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.6 BSI Group<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.7 T\u00dcV Rheinland<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.8 T\u00dcV Nord<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.9 Dekra SE<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.10 Bureau Veritas<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.11 DNV GL<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.12 Nemko<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.13 NSF International<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.14 Nelson Labs<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.15 Element Materials Technology<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.16 Charles River Laboratories<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.17 Smithers<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.18 Pace Analytical<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.19 M\u00e9rieux NutriSciences<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.20 Medistri SA<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-6\">\n    7. \uc2dc\uc7a5 \uae30\ud68c &amp; \ubbf8\ub798 \uc804\ub9dd<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc2dc\uc7a5 \uac1c\uc694 \ubcf4\uace0\uc11c 2031<\/p>\n<p>\uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc2dc\uc7a5\uc740 2025\ub144 105\uc5b5 5\ucc9c\ub9cc \ub2ec\ub7ec\uc5d0\uc11c 2026\ub144 109\uc5b5 5\ucc9c\ub9cc \ub2ec\ub7ec\ub85c \uc131\uc7a5\ud588\uc73c\uba70, 2031\ub144\uc5d0\ub294 131\uc5b5 5\ucc9c\ub9cc \ub2ec\ub7ec\uc5d0 \ub2ec\ud558\uc5ec \uc608\uce21 \uae30\uac04(2026-2031\ub144) \ub3d9\uc548 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960(CAGR) 3.75%\ub97c \uae30\ub85d\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc774 \uc2dc\uc7a5\uc740 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc774 \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud558\uace0 \uc788\uc73c\uba70, \ubd81\ubbf8\uac00 \uac00\uc7a5 \ud070 \uc2dc\uc7a5\uc744 \ud615\uc131\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc2dc\uc7a5 \uc9d1\uc911\ub3c4\ub294 \uc911\uac04 \uc218\uc900\uc785\ub2c8\ub2e4.<\/p>\n<p>\uc2dc\uc7a5 \ub3d9\uc778 \ubc0f \uc8fc\uc694 \ud2b8\ub80c\ub4dc<\/p>\n<p>\uc774\ub7ec\ud55c \uc131\uc7a5\uc740 \uc8fc\ub85c \uc720\ub7fd\uc5f0\ud569 \uc758\ub8cc\uae30\uae30 \uaddc\uc815(EU MDR)\uacfc \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc758 \uc0ac\uc774\ubc84 \ubcf4\uc548 \uc758\ubb34\ud654\uac00 \ub3d9\uc2dc\uc5d0 \uc2dc\ud589\ub418\uba74\uc11c \uc720\ud6a8\uc131 \uac80\uc0ac \ubc94\uc704\uc640 \ubb38\uc11c\ud654 \uc2ec\uce35\ub3c4\uac00 \ud655\ub300\ub41c \ub370 \uae30\uc778\ud569\ub2c8\ub2e4. \ud2b9\ud788 \uc911\uac04 \uc704\ud5d8\uad70\uc778 Class II \uae30\uae30\uac00 \uaddc\uc81c \uc900\uc218 \ubb3c\ub7c9\uc758 \ub300\ubd80\ubd84\uc744 \ucc28\uc9c0\ud558\uba70, \uc778\uacf5\uc9c0\ub2a5\/\uba38\uc2e0\ub7ec\ub2dd(AI\/ML) \uc54c\uace0\ub9ac\uc998 \ubc0f \uc5f0\uacb0\ud615 \uac00\uc815 \uc9c4\ub2e8 \uae30\uae30\uc758 \ud655\uc0b0\uc740 \uc0c8\ub85c\uc6b4 \uc2dc\ud5d8 \ud504\ub85c\ud1a0\ucf5c\uc744 \uc694\uad6c\ud558\uc5ec \ud504\ub9ac\ubbf8\uc5c4 \uc11c\ube44\uc2a4 \uc218\uc694\ub97c \ucd09\uc9c4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>EU MDR\uc740 2024-2028\ub144 \uc804\ud658 \uae30\uac04 \ub3d9\uc548 \ubaa8\ub4e0 \uae30\uc874 \uc758\ub8cc\uae30\uae30\uac00 23\uac00\uc9c0 \uc77c\ubc18 \uc548\uc804 \ubc0f \uc131\ub2a5 \uc694\uad6c\uc0ac\ud56d\uc5d0 \ub530\ub77c CE \ub9c8\ud06c\ub97c \uc7ac\ud68d\ub4dd\ud558\ub3c4\ub85d \uc758\ubb34\ud654\ud558\uc5ec, \ub9ce\uc740 \uc81c\uc870\uc5c5\uccb4\uc758 \uae30\uc220 \ubb38\uc11c \uc2ec\uce35\ub3c4\ub97c 3\ubc30 \uc99d\uac00\uc2dc\ucf30\uc2b5\ub2c8\ub2e4. \ub3d9\uc2dc\uc5d0 \ubbf8\uad6d Safer Devices Act\uc758 524B \uc870\ud56d\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc790\uc7ac \uba85\uc138\uc11c(SBOM) \ubc0f \ucde8\uc57d\uc810 \uad00\ub9ac \uacc4\ud68d\uc744 \ud3ec\ud568\ud558\ub294 \uc2dc\ud310 \uc804 \uc81c\ucd9c\uc744 \uc758\ubb34\ud654\ud558\uc5ec \ubaa8\ub4e0 \uc5f0\uacb0\ud615 \uc81c\ud488\uc758 \ubb38\uc11c\ud654 \ubd80\ub2f4\uc744 \uac00\uc911\uc2dc\ucf30\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uaddc\uc81c \uac15\ud654\ub294 \uc778\uc99d\uae30\uad00(Notified Body) \uc2e0\uccad \uac74\uc218\ub97c 40% \uc99d\uac00\uc2dc\ud0a4\uace0 \ud3c9\uade0 \uac80\ud1a0 \uc2dc\uac04\uc744 24\uac1c\uc6d4 \uc774\uc0c1\uc73c\ub85c \uc5f0\uc7a5\uc2dc\ucf1c, \uae30\uc5c5\ub4e4\uc774 \ub354 \ud070 \uaddc\ubaa8\uc758 \uc720\ud6a8\uc131 \uac80\uc0ac \ud328\ud0a4\uc9c0\ub97c \uacf5\uc778 \uc2dc\ud5d8\uc18c\uc5d0 \uc544\uc6c3\uc18c\uc2f1\ud558\ub3c4\ub85d \uc720\ub3c4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>AI\/ML \uae30\ubc18 \uc758\ub8cc\uae30\uae30\uc758 \uae09\uc99d \ub610\ud55c \uc2dc\uc7a5 \uc131\uc7a5\uc758 \uc8fc\uc694 \ub3d9\uc778\uc785\ub2c8\ub2e4. 2024\ub144 5\uc6d4 \uae30\uc900 FDA \uacf5\uacf5 \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc5d0\ub294 882\uac1c\uc758 AI\/ML \uc758\ub8cc\uae30\uae30\uac00 \uc2b9\uc778\ub418\uc5c8\uc73c\uba70, \uc774\ub294 \uc804\ub144 \ub300\ube44 45% \uc99d\uac00\ud55c \uc218\uce58\uc785\ub2c8\ub2e4. \uac01 \uc54c\uace0\ub9ac\uc998\uc740 \ud3b8\ud5a5 \uac10\uc9c0, \ub370\uc774\ud130\uc14b \ubcc0\ud654 \ubd84\uc11d, \uc2e4\uc81c \uc131\ub2a5 \ubaa8\ub2c8\ud130\ub9c1\uc744 \uc694\uad6c\ud558\uba70, \uc774\ub294 \uae30\uc874 \uac80\uc99d \ubc94\uc704\ub97c \ub118\uc5b4\uc12d\ub2c8\ub2e4. \uc758\ub8cc AI\ub97c &#8220;\uace0\uc704\ud5d8&#8221;\uc73c\ub85c \ubd84\ub958\ud558\ub294 EU AI Act\ub294 \uc218\uba85 \uc8fc\uae30 \uc704\ud5d8 \uad00\ub9ac\ub97c \ucd94\uac00\ub85c \uc694\uad6c\ud569\ub2c8\ub2e4. \uc774\uc5d0 \ub530\ub77c \uc54c\uace0\ub9ac\uc998 \uac10\uc0ac \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud558\ub294 \uc2dc\ud5d8\uc18c\ub294 \ud504\ub9ac\ubbf8\uc5c4 \uac00\uaca9\uc744 \ucc45\uc815\ud560 \uc218 \uc788\uc73c\uba70, \uc774 \uc11c\ube44\uc2a4 \ub77c\uc778\uc740 \ud5a5\ud6c4 10\ub144\uac04 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc758 \ud575\uc2ec \uc218\uc775\uc6d0\uc774 \ub420 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n<p>\uac00\uc815\uc6a9 \ubc0f \uc6e8\uc5b4\ub7ec\ube14 \uc9c4\ub2e8 \uae30\uae30\uc758 \uc131\uc7a5\ub3c4 \uc2dc\ud5d8 \ubb3c\ub7c9 \ud655\ub300\ub97c \uc774\ub04c\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud32c\ub370\ubbf9 \uae30\uac04 \ub3d9\uc548 \uc2e0\uc18d \ud56d\uc6d0 \ud0a4\ud2b8\uc5d0 \ub300\ud55c \uc18c\ube44\uc790 \uce5c\uc219\ub3c4\ub294 \uc5f0\uacb0\ud615 \ud608\ub2f9 \uce21\uc815\uae30, ECG \ud328\uce58, \ub2e4\uc911 \ubd84\uc11d \uc6e8\uc5b4\ub7ec\ube14 \uae30\uae30\uc758 \ucc44\ud0dd\uc744 \uac00\uc18d\ud654\ud588\uc2b5\ub2c8\ub2e4. \uaddc\uc81c \ub2f9\uad6d\uc740 \uc774\uc81c \uc784\uc0c1 \ud658\uacbd \uc678\ubd80\uc5d0\uc11c \uc218\uc9d1\ub41c \uc0ac\uc6a9\uc131 \ubc0f \uc778\uc801 \uc694\uc18c \uc99d\uac70\ub97c \uc694\uad6c\ud558\uba70, \uace0\uc6a9\ub7c9 \uc18c\ube44\uc790 \uae30\uae30\uc758 \uc5f0\uac04 \uc2dc\ud5d8 \ub2e8\uc704 \uc218\ub97c \uac70\uc758 30% \uc99d\uac00\uc2dc\ud0a4\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ubd84\uc0b0\ud615 \uc0ac\uc6a9\uc790 \uc5f0\uad6c \ubc0f \ud658\uacbd \uc2a4\ud2b8\ub808\uc2a4 \uc2dc\ubbac\ub808\uc774\uc158\uc744 \uc218\ud589\ud560 \uc218 \uc788\ub294 \uc2dc\ud5d8\uc18c\ub294 \ube60\ub978 \uae00\ub85c\ubc8c \ucd9c\uc2dc\ub97c \uc6d0\ud558\ub294 \ube0c\ub79c\ub4dc\ub85c\ubd80\ud130 \uc9c0\uc18d\uc801\uc778 \ube44\uc988\ub2c8\uc2a4\ub97c \uc720\uce58\ud558\uc5ec \uc2dc\uc7a5 \uc131\uc7a5\uc744 \ub4b7\ubc1b\uce68\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc0ac\uc774\ubc84 \ubcf4\uc548 \uc2dc\ud310 \uc804 \uc81c\ucd9c \uc758\ubb34\ud654\ub3c4 \uc911\uc694\ud55c \ub3d9\uc778\uc785\ub2c8\ub2e4. 2023\ub144 10\uc6d4\ubd80\ud130 FDA\ub294 \ubcf4\uc548 \uc124\uacc4 \ubb38\uc11c\uac00 \ubd80\uc871\ud55c 510(k) \uc81c\ucd9c\uc744 \uac70\ubd80\ud558\uace0 \uc788\uc73c\uba70, \ucde8\uc57d\uc810 \uacf5\uac1c \uc815\ucc45 \uc5c6\uc774 \ucd9c\uc2dc\ub41c \uc5f0\uacb0\ud615 \uae30\uae30\ub294 \uc218\uc785 \ubcf4\ub958 \uc704\ud5d8\uc5d0 \ucc98\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. UL 2900 \uc778\uc99d \uacbd\ub85c\ub294 \uc0ac\uc2e4\uc0c1\uc758 \ubca4\uce58\ub9c8\ud06c\uac00 \ub418\uc5c8\uc73c\uba70, \uce68\ud22c \ud14c\uc2a4\ud2b8 \uc7a5\ube44\uc5d0 \uc870\uae30\uc5d0 \ud22c\uc790\ud55c \uc2dc\ud5d8\uc18c\ub294 2026\ub144 \uc911\ubc18\uae4c\uc9c0 \ud504\ub85c\uc81d\ud2b8 \ud30c\uc774\ud504\ub77c\uc778\uc774 \uac00\ub4dd \ucc28 \uc788\uc5b4 \uc0ac\uc774\ubc84 \ubcf4\uc548\uc774 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \ub0b4\uc5d0\uc11c \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud558\ub294 \uc218\uc775 \ud2c8\uc0c8 \uc2dc\uc7a5\uc784\uc744 \uc785\uc99d\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc720\ub7fd\uc758 \uacf5\uacf5 \uc870\ub2ec \uaddc\uce59\uc5d0 \uc758\ud574 \uc8fc\ub3c4\ub418\ub294 \uc9c0\uc18d\uac00\ub2a5\uc131 \uac10\uc0ac\uc640 \uc885\ub2e8 \uac04 \uc0ac\uc774\ubc84 \ubcf4\uc548 \ud3c9\uac00\ub294 \ud1b5\ud569\ub41c \ucc38\uc5ec\uc5d0 \ub300\ud574 \ub354 \ub192\uc740 \ub9c8\uc9c4\uc744 \uccad\uad6c\ud560 \uc218 \uc788\ub294 \ucc28\ubcc4\ud654 \uc694\uc18c\ub85c \ubd80\uc0c1\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc2dc\uc7a5 \uc81c\uc57d \uc694\uc778<\/p>\n<p>\uadf8\ub7ec\ub098 \uc2dc\uc7a5\uc740 \uba87 \uac00\uc9c0 \uc81c\uc57d \uc694\uc778\uc5d0 \uc9c1\uba74\ud574 \uc788\uc2b5\ub2c8\ub2e4. EU \uc778\uc99d\uae30\uad00(Notified Body)\uc758 \uc81c\ud55c\ub41c \uc5ed\ub7c9\uacfc \uae34 \ub9ac\ub4dc \ud0c0\uc784\uc740 \uc8fc\uc694 \uc81c\uc57d \uc694\uc778\uc785\ub2c8\ub2e4. MDR\uc5d0 \ub530\ub77c EU \uc804\uccb4\ub97c \uc11c\ube44\uc2a4\ud558\ub294 \uc778\uc99d\uae30\uad00\uc740 43\uac1c\uc5d0 \ubd88\uacfc\ud558\uba70, \uc2e0\uccad \ub300\ube44 \uc778\uc99d \ube44\uc728\uc740 4:1\uc744 \ucd08\uacfc\ud569\ub2c8\ub2e4. \ud3c9\uade0 \uac80\ud1a0 \uc2dc\uac04\uc740 2022\ub144 14\uac1c\uc6d4\uc5d0\uc11c 2024\ub144 \ub9d0 26\uac1c\uc6d4 \uc774\uc0c1\uc73c\ub85c \uc99d\uac00\ud588\uc2b5\ub2c8\ub2e4. \uc774\ub85c \uc778\ud574 \uc81c\uc870\uc5c5\uccb4\ub4e4\uc740 \uc77c\ubd80 \uc800\ub9c8\uc9c4 \uc81c\ud488\uc744 EU \uc2dc\uc7a5\uc5d0\uc11c \ucca0\uc218\uc2dc\ud0a4\uace0 \uc788\uc73c\uba70, \uc774\ub294 \uc7a0\uc7ac\uc801\uc778 \uc2dc\ud5d8 \ubb3c\ub7c9\uc744 \uac10\uc18c\uc2dc\ud0a4\uace0 \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uc5b5\uc81c\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc911\uc18c\uae30\uc5c5(SME) \ubc0f \uc2a4\ud0c0\ud2b8\uc5c5\uc5d0\uac8c \ub192\uc740 \uc2dc\ud5d8 \ube44\uc6a9\ub3c4 \ubd80\ub2f4\uc73c\ub85c \uc791\uc6a9\ud569\ub2c8\ub2e4. \ud3ec\uad04\uc801\uc778 \uc0dd\uccb4 \uc801\ud569\uc131, \uba78\uade0, EMC, \uc0ac\uc774\ubc84 \ubcf4\uc548 \ud328\ud0a4\uc9c0\ub294 \uae30\ubcf8\uc801\uc778 Class II \uc720\ud6a8\uc131 \uac80\uc0ac \ube44\uc6a9\uc744 50\ub9cc \ub2ec\ub7ec \uc774\uc0c1\uc73c\ub85c \ub04c\uc5b4\uc62c\ub824 \ubca4\ucc98 \uc9c0\uc6d0 \uc2a4\ud0c0\ud2b8\uc5c5\uc5d0 \ud070 \ubd80\ub2f4\uc744 \uc90d\ub2c8\ub2e4. FDA\uac00 \uc18c\uae30\uc5c5\uc5d0 510(k) \uc218\uc218\ub8cc\ub97c \uac10\uba74\ud574\uc8fc\uc9c0\ub9cc, \uc774\ub294 \uc81c\ucd9c \ube44\uc6a9\ub9cc \ud574\ub2f9\ud558\uba70 \uc2dc\ud5d8\uc18c \uc791\uc5c5 \ube44\uc6a9\uc740 \ud3ec\ud568\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ub9ce\uc740 \uc911\uc18c\uae30\uc5c5\uc740 \ucd9c\uc2dc\ub97c \uc5f0\uae30\ud558\uac70\ub098 \uaddc\uc81c\uac00 \ub35c\ud55c \uc2dc\uc7a5\uc73c\ub85c \uc804\ud658\ud558\uc5ec \uc989\uac01\uc801\uc778 \uc11c\ube44\uc2a4 \uc218\uc694\ub97c \uc904\uc774\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ub610\ud55c AI \uc54c\uace0\ub9ac\uc998 \uc720\ud6a8\uc131 \uac80\uc0ac\ub97c \uc704\ud55c \ud45c\uc900\ud654\ub41c \ub370\uc774\ud130\uc14b \ubd80\uc871\uacfc \ud30c\ud3b8\ud654\ub41c \uc9c0\uc18d\uac00\ub2a5\uc131 \uaddc\uc81c \uc900\uc218 \uc694\uad6c\uc0ac\ud56d\ub3c4 \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uc800\ud574\ud558\ub294 \uc694\uc778\uc73c\ub85c \uc791\uc6a9\ud569\ub2c8\ub2e4.<\/p>\n<p>\uc138\uadf8\uba3c\ud2b8 \ubd84\uc11d<\/p>\n<p>\uc11c\ube44\uc2a4 \uc720\ud615\ubcc4: \uc2dc\ud5d8 \uc11c\ube44\uc2a4\ub294 2025\ub144 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc2dc\uc7a5 \uc810\uc720\uc728\uc758 55.98%\ub97c \ucc28\uc9c0\ud558\uba70, \ubaa8\ub4e0 \uae30\uae30 \ub4f1\uae09\uc5d0 \ub300\ud55c \ud544\uc218\uc801\uc778 \uaddc\uc81c \uc9c4\uc785 \uc694\uac74\uc73c\ub85c\uc11c\uc758 \uc704\uc0c1\uc744 \ubc18\uc601\ud569\ub2c8\ub2e4. \uc778\uc99d \uc11c\ube44\uc2a4\ub294 EU \ubc0f \uc601\uad6d \uacbd\ub85c\ub9cc\uc774 \ubc95\uc801\uc73c\ub85c \uc81c3\uc790 \uac10\uc0ac\ub97c \uc694\uad6c\ud558\ub294 \ubc18\uba74, \ubbf8\uad6d\uc740 \uc81c\uc870\uc5c5\uccb4 \uc790\uccb4 \uc778\uc99d\uc5d0 \ub354 \uc758\uc874\ud558\uae30 \ub54c\ubb38\uc5d0 \uadf8 \ub4a4\ub97c \ub530\ub985\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uaddc\uc81c \ub2f9\uad6d\uc774 \uc2dc\ud310 \ud6c4 \uac10\uc2dc\ub97c \uac15\ud654\ud568\uc5d0 \ub530\ub77c \uac80\uc0ac \ubc0f \uac10\uc0ac \uc218\uc775\uc774 \uc99d\uac00\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \ub0b4\uc5d0 \ud1b5\uacc4\uc801\uc73c\ub85c \ud3ec\ud568\ub418\uc5b4 \uc788\ub294 \uc0ac\uc774\ubc84 \ubcf4\uc548 \ubc0f \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc720\ud6a8\uc131 \uac80\uc0ac\ub294 FDA \ubc0f \uce90\ub098\ub2e4 \ubcf4\uac74\ubd80\uc758 \uc758\ubb34\ud654\ub85c \uc778\ud574 5.03%\uc758 CAGR\uc744 \uae30\ub85d\ud558\uba70 \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud558\ub294 \uc218\uc775\uc6d0\uc785\ub2c8\ub2e4. \uc0dd\ubb3c\ud559\uc801, \uae30\uacc4\uc801, \ub514\uc9c0\ud138 \ubcf4\uc548 \uc2dc\ud5d8\ub300\ub97c \ud55c \uacf3\uc5d0 \ud1b5\ud569\ud55c \uc2dc\ud5d8\uc18c\ub294 \ucd1d \ucc98\ub9ac \uc2dc\uac04\uc744 \ucd5c\ub300 30% \ub2e8\ucd95\ud558\uc5ec \ud504\ub9ac\ubbf8\uc5c4 \uc694\uae08\uc744 \uccad\uad6c\ud558\uace0 \uacbd\uc7c1 \uc6b0\uc704\ub97c \uac15\ud654\ud569\ub2c8\ub2e4. \uacb0\uacfc\uc801\uc73c\ub85c \uc2dc\uc7a5\uc740 \ub2e4\ub144\uac04\uc758 \uc218\uc775 \uac00\uc2dc\uc131\uc744 \ud655\ubcf4\ud558\ub294 \ubc88\ub4e4\ud615, \uad6c\ub3c5\ud615 \ud488\uc9c8 \ubcf4\uc99d \uacc4\uc57d\uc73c\ub85c \uc804\ud658\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc790\ub3d9\ud654\ub41c \uc0d8\ud50c \uc900\ube44 \ubc0f \uace0\ucc98\ub9ac\ub7c9 \ubd84\uc11d\uc5d0 \ub300\ud55c \uc9c0\uc18d\uc801\uc778 \ud22c\uc790\ub294 2022\ub144 \uc774\ud6c4 \ubcf4\uace0\uc11c\ub2f9 \uc9c1\uc811 \ub178\ub3d9\ub825\uc744 \uac70\uc758 10% \uac10\uc18c\uc2dc\ucf1c \uc6b4\uc601 \ub9c8\uc9c4\uc744 \ub192\uc600\uc2b5\ub2c8\ub2e4. \uc778\uc99d \uc11c\ube44\uc2a4\ub294 \uc778\uc99d\uae30\uad00 \ubd80\uc871\uc73c\ub85c \uc778\ud574 2.44%\ub85c \ub354 \ub290\ub9ac\uac8c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\uc9c0\ub9cc, EU \uc2dc\uc7a5 \uc811\uadfc\uc744 \uc704\ud574 \ud544\uc218\uc801\uc774\ubbc0\ub85c \ubc29\uc5b4\uc801\uc778 \uc218\uc775 \uae30\ubc18\uc744 \uc720\uc9c0\ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p>\uae30\uae30 \ub4f1\uae09\ubcc4: Class II \uae30\uae30\ub294 \ub192\uc740 \ub2e8\uc704 \ubb3c\ub7c9\uacfc \uc5c4\uaca9\ud55c \uc99d\uac70 \uc694\uad6c\uc0ac\ud56d\uc758 \uade0\ud615\uc744 \uc774\ub8e8\uae30 \ub54c\ubb38\uc5d0 2025\ub144 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc2dc\uc7a5 \uaddc\ubaa8\uc758 42.78%\ub97c \ucc28\uc9c0\ud588\uc2b5\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \uc8fc\uc785 \ud38c\ud504, \uc804\ub3d9 \ud720\uccb4\uc5b4, \ub9ce\uc740 AI \uae30\ubc18 \uc601\uc0c1 \uae30\uae30\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4. FDA\uc758 \uc0ac\uc804 \uacb0\uc815 \ubcc0\uacbd \uad00\ub9ac \uacc4\ud68d(Predetermined Change Control Plan)\uc5d0 \ub530\ub77c \uac1c\ubc1c\uc790\ub294 \uc131\ub2a5 \ud55c\uacc4\ub97c \uac80\uc99d\ud558\ub294 \ud55c \uc0c8\ub85c\uc6b4 510(k)\ub97c \uc81c\ucd9c\ud558\uc9c0 \uc54a\uace0\ub3c4 \uc54c\uace0\ub9ac\uc998\uc744 \uc218\uc815\ud560 \uc218 \uc788\uc5b4, \ubaa8\ub378\uc774 \uc5c5\ub370\uc774\ud2b8\ub420 \ub54c\ub9c8\ub2e4 \ubc18\ubcf5\uc801\uc778 \uc2dc\ud5d8 \uc9c0\ucd9c\uc774 \ubc1c\uc0dd\ud569\ub2c8\ub2e4. Class III \uae30\uae30\ub294 \uc218\uac00 \uc801\uc9c0\ub9cc \ud544\uc218\uc801\uc778 \uc784\uc0c1 \uc99d\uac70\uc640 10^-6\uc758 \uba78\uade0 \ubcf4\uc99d \uc218\uc900\uc73c\ub85c \uc778\ud574 \ud504\ub9ac\ubbf8\uc5c4 \uc218\uc218\ub8cc\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. Class I \uae30\uae30 \ubb3c\ub7c9\uc740 \uc790\uccb4 \uc2dc\ud5d8\uc73c\ub85c \uacc4\uc18d \uc804\ud658\ub418\uace0 \uc788\uc9c0\ub9cc, \uc0ac\uc774\ubc84 \ubcf4\uc548 \uc870\ud56d\uc73c\ub85c \uc778\ud574 \uc77c\ubd80 \uc5f0\uacb0\ud615 \uae30\uae30\ub294 \uc81c3\uc790 \uc2dc\ud5d8\uc18c\ub85c \uc720\uc785\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uccb4\uc678 \uc9c4\ub2e8(IVD) \uae30\uae30\ub294 EU IVDR\uc774 \uc804\ud658 \uae30\ud55c\uc744 2028\ub144\uc73c\ub85c \uc5f0\uc7a5\ud568\uc5d0 \ub530\ub77c \uc778\uc99d \uc801\uccb4 \ud604\uc0c1\uc774 \uc9c0\uc18d\ub418\uc5b4 \ub3c5\ud2b9\ud55c \uc131\uc7a5 \ub3d9\ub825\uc744 \uc720\uc9c0\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc804\ubc18\uc801\uc73c\ub85c \uc911\uac04 \uc704\ud5d8 \uc81c\ud488\uc758 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ucf58\ud150\uce20 \uc99d\uac00\ub294 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc744 Class II \uc601\uc5ed\uc5d0 \ud655\uace0\ud788 \uace0\uc815\uc2dc\ud0a4\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc2dc\ud5d8 \uc720\ud615\ubcc4: \uba78\uade0 \ubc0f \ubbf8\uc0dd\ubb3c\ud559 \uc2dc\ud5d8\uc740 \uc784\ud50c\ub780\ud2b8, \uc77c\ud68c\uc6a9\ud488, \ubcf5\ud569 \uc81c\ud488 \uc804\ubc18\uc5d0 \uac78\uce5c \ubcf4\ud3b8\uc801\uc778 \uc801\uc6a9 \uac00\ub2a5\uc131\uc73c\ub85c \uc778\ud574 2025\ub144 \uc218\uc775 \uc810\uc720\uc728\uc758 36.92%\ub97c \uc720\uc9c0\ud588\uc2b5\ub2c8\ub2e4. \uc2e0\uc18d \ubbf8\uc0dd\ubb3c \ubc29\ubc95\uc5d0 \ub300\ud55c ISO 11737 \uc5c5\ub370\uc774\ud2b8\ub294 \uc2dc\ud5d8\uc18c\ub4e4\uc774 PCR \uae30\ubc18 \ud50c\ub7ab\ud3fc\uc5d0 \ud22c\uc790\ud558\uc5ec \uc778\uc99d\uae4c\uc9c0\uc758 \uc2dc\uac04\uc744 2-3\uc77c \ub2e8\ucd95\ud558\ub3c4\ub85d \uc7a5\ub824\ud569\ub2c8\ub2e4. \ub3d9\uc2dc\uc5d0 \uc0ac\uc774\ubc84 \ubcf4\uc548 \uc2dc\ud5d8\uc740 \ub514\uc9c0\ud138 \uc5f0\uacb0 \uae30\uae30\ub85c\uc758 \ubc95\uc801 \uc804\ud658\uc744 \ubc18\uc601\ud558\uc5ec 5.83%\uc758 CAGR\ub85c \uac00\uc7a5 \uac15\ub825\ud55c \uc131\uc7a5\uc744 \uae30\ub85d\ud588\uc2b5\ub2c8\ub2e4. \ubaa8\ub4e0 \uc2e0\uaddc \uae30\uae30\uac00 \ubb34\uc120 \uad6c\uc131 \uc694\uc18c\ub97c \ud1b5\ud569\ud558\uae30 \ub54c\ubb38\uc5d0 \uc804\uae30 \uc548\uc804 \ubc0f \uc804\uc790\uae30 \ud638\ud658\uc131(EMC)\uc740 \uacc4\uc18d\ud574\uc11c \uc911\uc694\uc131\uc744 \uc720\uc9c0\ud569\ub2c8\ub2e4. \ud3ec\uc7a5 \ubc0f \uc720\ud1b5 \uae30\ud55c \ubd84\uc11d\uc740 \uc0c8\ub85c\uc6b4 \uc548\uc815\uc131 \ub370\uc774\ud130\uc14b\uc744 \uc694\uad6c\ud558\ub294 \uce5c\ud658\uacbd \uc7ac\ub8cc\uc758 \uc601\ud5a5\uc73c\ub85c \uc131\uc7a5\uc138\ub97c \ubcf4\uc785\ub2c8\ub2e4. \ubc18\ub300\ub85c \uba78\uade0 \uc2dc\ud5d8\uc740 2.98%\ub85c \ub354 \ub290\ub9ac\uac8c \uc99d\uac00\ud558\uc9c0\ub9cc, \uc608\uce21 \uae30\uac04 \ub3d9\uc548 \uc808\ub300\uc801\uc778 \uce21\uba74\uc5d0\uc11c \uac70\uc758 6\uc5b5 \ub2ec\ub7ec\ub97c \ucd94\uac00\ud560 \uac83\uc785\ub2c8\ub2e4. \uc2dc\ud5d8\uc18c\ub4e4\uc774 \ub514\uc9c0\ud138 \ubc0f \ubbf8\uc0dd\ubb3c\ud559 \uc11c\ube44\uc2a4\ub97c \uad50\ucc28 \ud310\ub9e4\ud568\uc5d0 \ub530\ub77c \ud3c9\uade0 \ud504\ub85c\uc81d\ud2b8 \uac00\uce58\uac00 \uc99d\uac00\ud558\uc5ec \uc8fc\ubb38 \uc7a5\ubd80\uc758 \ud0c4\ub825\uc131\uc774 \ud5a5\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc9c0\uc5ed \ubd84\uc11d<\/p>\n<p>\ubd81\ubbf8\ub294 FDA\uc758 \uac04\uc18c\ud654\ub41c 510(k) \ubc0f \ud601\uc2e0 \uae30\uae30(Breakthrough Device) \uacbd\ub85c\uac00 \uc9c0\uc18d\uc801\uc778 \uc81c\ud488 \ucd9c\uc2dc\ub97c \ucd09\uc9c4\ud558\ub294 \ub370 \ud798\uc785\uc5b4 2025\ub144 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc758 38.42%\ub97c \ucc28\uc9c0\ud588\uc2b5\ub2c8\ub2e4. \uad6d\ub0b4 \uc2dc\ud5d8\uc18c\ub294 \ud601\uc2e0\uc744 \uc9c0\uc6d0\ud558\ub294 \uc2ec\uce35\uc801\uc778 \uc9c0\ubd88 \uc2dc\uc2a4\ud15c\uacfc \uc5ec\ub7ec \uc790\ubc1c\uc801 \ud569\uc758 \ud45c\uc900\uc744 \uba85\uc2dc\uc801\uc73c\ub85c \uc778\uc815\ud558\uc5ec \uc720\ud6a8\uc131 \uac80\uc0ac \uc8fc\uae30\ub97c \ub2e8\ucd95\ud558\ub294 \uaddc\uc81c \ud658\uacbd\uc758 \ud61c\ud0dd\uc744 \ubc1b\uc2b5\ub2c8\ub2e4. 2026\ub144\ubd80\ud130 2031\ub144\uae4c\uc9c0 \uc774 \uc9c0\uc5ed\uc740 \uc131\uc219\ub3c4 \ub54c\ubb38\uc5d0 \uae00\ub85c\ubc8c \ud3c9\uade0\ubcf4\ub2e4 \ub290\ub9b0 3.05%\uc758 CAGR\ub85c \ud655\uc7a5\ub420 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591\uc740 \uc5f0\uac04 6.42% \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\ub294 \uba85\ud655\ud55c \ubb3c\ub7c9 \uc5d4\uc9c4\uc785\ub2c8\ub2e4. 2024\ub144 7\uc6d4\ubd80\ud130 \uc2dc\ud589\ub418\ub294 \uc911\uad6d\uc758 \uac1c\uc815\ub41c \uc758\ub8cc\uae30\uae30 \uaddc\uc815\uc740 \ud604\uc9c0 \uc81c\uc870\uc5c5\uccb4\uc5d0\uac8c \uc81c3\uc790 \uc0dd\uccb4 \uc801\ud569\uc131 \ubc0f \ud3ec\uc7a5 \ub370\uc774\ud130\ub97c \ud655\ubcf4\ud558\ub3c4\ub85d \uc758\ubb34\ud654\ud558\uc5ec \uc9c0\uc5ed \uc2dc\ud5d8\uc18c\ub85c\uc758 \uafb8\uc900\ud55c \uc0d8\ud50c \uc720\uc785\uc744 \uc720\ub3c4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. 2024\ub144 \uc778\ub3c4\uc758 \uc758\ub8cc\uae30\uae30 \uaddc\uce59 \uac1c\uc815\uc740 \ucd94\uac00 \uc81c\ud488 \ubc94\uc8fc\uc5d0 \ub300\ud55c \uc81c3\uc790 \uac10\uc0ac \uc694\uad6c\uc0ac\ud56d\uc744 \ud655\ub300\ud558\uc5ec \uc810\uc9c4\uc801\uc778 \uc218\uc694\ub97c \ucd94\uac00\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc678\uad6d \uae30\uc5c5\ub4e4\uc740 \uc99d\uac00\ud558\ub294 \uc218\uc694\ub97c \ud3ec\ucc29\ud558\uae30 \uc704\ud574 \uc464\uc800\uc6b0, \ubc29\uac08\ub85c\ub974, \ucfe0\uc54c\ub77c\ub8f8\ud478\ub974\uc5d0 \uc704\uc131 \uc2dc\ud5d8\uc18c\ub97c \ube60\ub974\uac8c \uac1c\uc124\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc720\ub7fd\uc740 \uc778\uc99d\uae30\uad00 \ubd80\uc871\uc73c\ub85c \ub2e8\uae30\uc801\uc778 \uce68\uccb4\ub97c \uacaa\uc5c8\uc9c0\ub9cc, \uc5ed\ub7c9\uc774 \uc815\uc0c1\ud654\ub418\uba74 \uc5f0\uae30\ub41c \uc2e0\uccad\uc774 \uccad\uad6c \uac00\ub2a5\ud55c \uc2dc\ud5d8\uc73c\ub85c \uc804\ud658\ub418\uc5b4 2027\ub144 \uc774\ud6c4 \uc9c0\uc5ed\uc774 \ub2e4\uc2dc \ud65c\ub825\uc744 \ub418\ucc3e\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uac83\uc785\ub2c8\ub2e4. \ub77c\ud2f4 \uc544\uba54\ub9ac\uce74\uc640 \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74\ub294 \uc544\uc9c1 \ucd08\uae30 \ub2e8\uacc4\uc774\uc9c0\ub9cc, \uc77c\ubc18\uc801\uc73c\ub85c \uae00\ub85c\ubc8c \uc2dc\ud5d8\uc18c \ub124\ud2b8\uc6cc\ud06c\uc5d0 \uc758\ud574 \uc218\ud589\ub418\ub294 \ucc38\uc870 \uc2dc\uc7a5 \ud45c\uc900 \uc900\uc218 \uc99d\uba85\uc744 \uc694\uad6c\ud558\ub294 \uc870\ud654 \uc774\ub2c8\uc154\ud2f0\ube0c\uc758 \ud61c\ud0dd\uc744 \ubc1b\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uacbd\uc7c1 \ud658\uacbd<\/p>\n<p>\uacbd\uc7c1 \ud658\uacbd\uc740 \uc911\uac04 \uc815\ub3c4\uc758 \uc9d1\uc911\ub3c4\ub97c \ubcf4\uc774\uba70, \uc8fc\uc694 \uacf5\uae09\uc5c5\uccb4\ub85c\ub294 SGS SA, Intertek Group plc, Eurofins Scientific SE, T\u00dcV S\u00dcD, UL Solutions \ub4f1\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub4e4 \uae30\uc5c5\uc740 ISO\/IEC 17025, ISO 13485 \ubc0f \ub2e4\uc218\uc758 \uaddc\uc81c \ub2f9\uad6d \uc778\uc815\uc744 \ud3ec\uad04\ud558\ub294 \uad11\ubc94\uc704\ud55c \uc778\uc99d \ud3ec\ud2b8\ud3f4\ub9ac\uc624\ub97c \ud65c\uc6a9\ud558\uc5ec \ub2e4\uad6d\uc801 \uacc4\uc57d\uc744 \uc218\uc8fc\ud569\ub2c8\ub2e4. SGS\ub294 2025\ub144 1\uc6d4 Agilex Biolabs\uc640\uc758 \ud30c\ud2b8\ub108\uc2ed\uc744 \ud1b5\ud574 \ubbf8\uad6d \uc0dd\uccb4 \ubd84\uc11d \uc2dc\ud5d8\uc744 \ud655\uc7a5\ud558\uc5ec \uc804\uc784\uc0c1\ubd80\ud130 \uc2dc\ud310 \ud6c4\uae4c\uc9c0\uc758 \uc885\ub2e8 \uac04 \uc11c\ube44\uc2a4\ub97c \uac15\ud654\ud588\uc2b5\ub2c8\ub2e4. Intertek, T\u00dcV S\u00dcD, UL Solutions\ub294 \ub370\uc774\ud130 \uc785\ub825 \uc624\ub958\ub97c \uc904\uc774\uace0 \ubcf4\uace0\uc11c \uc0dd\uc131\uc744 \uac00\uc18d\ud654\ud558\ub294 \uc790\ub3d9\ud654\ub41c \uc2dc\ud5d8\uc18c \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \ubc30\ud3ec\ud558\uc5ec \ub514\uc9c0\ud138 \ucd94\uc801\uc131\uc744 \ucd94\uad6c\ud558\ub294 \ub2e4\uad6d\uc801 \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc640 \ubc18\ubcf5\uc801\uc778 \ube44\uc988\ub2c8\uc2a4\ub97c \ud655\ubcf4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. Eurofins\ub294 2024\ub144 12\uc6d4 Infinity Laboratories \uc778\uc218\ub97c \ud1b5\ud574 \uc758\ub8cc \ud3ec\ud2b8\ud3f4\ub9ac\uc624\ub97c \uc2ec\ud654\ud588\uc73c\uba70, \ubbf8\uc0dd\ubb3c\ud559 \ubc0f \ud3ec\uc7a5 \uc2dc\ud5d8 \uc804\ubb38 \ubbf8\uad6d \uc2dc\uc124 8\uacf3\uc744 \ucd94\uac00\ud588\uc2b5\ub2c8\ub2e4. Applus+\uac00 Keystone Compliance\ub97c \uc778\uc218\ud558\uace0 Apave\uac00 Baltic Control\uc744 \uc778\uc218\ud558\ub294 \ub4f1 \uc911\uacac \uae30\uc5c5\ub4e4\uc758 \ud569\ubcd1 \ubb3c\uacb0\uc740 \uc99d\uac00\ud558\ub294 \uaddc\uc81c \uc900\uc218 \uac04\uc811\ube44\ub97c \uc0c1\uc1c4\ud558\uace0 \uc9c0\ub9ac\uc801 \ubc94\uc704\ub97c \ub113\ud788\uae30 \uc704\ud55c \uaddc\ubaa8 \ud655\uc7a5\uc758 \uc9c0\uc18d\uc801\uc778 \ucd94\uc9c4\uc744 \uc2dc\uc0ac\ud569\ub2c8\ub2e4.<\/p>\n<p>Nelson Labs, BSI Group, Element Materials Technology\uc640 \uac19\uc740 \ud2c8\uc0c8Nelson Labs, BSI Group, Element Materials Technology\uc640 \uac19\uc740 \ud2c8\uc0c8 \uc2dc\ud5d8\uc18c\ub4e4\uc740 \ud2b9\uc815 \uc758\ub8cc \uae30\uae30 \ubd84\uc57c\uc5d0\uc11c \uae4a\uc774 \uc788\ub294 \uc804\ubb38\uc131\uc744 \uc81c\uacf5\ud558\uba70 \uc2dc\uc7a5\uc758 \uc911\uc694\ud55c \ubd80\ubd84\uc744 \ucc28\uc9c0\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc2dc\uc7a5 \ud1b5\ud569\uacfc \uae30\uc220 \ubc1c\uc804\uc740 \uc758\ub8cc \uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc11c\ube44\uc2a4 \uc0b0\uc5c5\uc774 \ub354\uc6b1 \ubcf5\uc7a1\ud558\uace0 \uc804\ubb38\ud654\ub41c \ubc29\ud5a5\uc73c\ub85c \uc9c4\ud654\ud558\uace0 \uc788\uc74c\uc744 \ubcf4\uc5ec\uc90d\ub2c8\ub2e4. \uaddc\uc81c \ud658\uacbd\uc774 \uac15\ud654\ub418\uace0 \uc2e0\uae30\uc220 \ub3c4\uc785\uc774 \uac00\uc18d\ud654\ub428\uc5d0 \ub530\ub77c, \uc2dc\ud5d8\uc18c\ub4e4\uc740 \ud6a8\uc728\uc131\uc744 \ub192\uc774\uace0 \uc11c\ube44\uc2a4 \ubc94\uc704\ub97c \ud655\uc7a5\ud558\uba70 \uace0\uac1d\uc758 \ub2e4\uc591\ud55c \uc694\uad6c\ub97c \ucda9\uc871\uc2dc\ud0a4\uae30 \uc704\ud574 \uc9c0\uc18d\uc801\uc73c\ub85c \ud601\uc2e0\ud574\uc57c \ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p>\ubcf8 \ubcf4\uace0\uc11c\ub294 \uc758\ub8cc\uae30\uae30 \uc548\uc804\uc131 \ud655\ubcf4\ub97c \uc704\ud55c \uc2dc\ud5d8, \uc778\uc99d \ubc0f \uac10\uc0ac \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc758 \uae00\ub85c\ubc8c \ub3d9\ud5a5\uc744 \ubd84\uc11d\ud569\ub2c8\ub2e4. \uc774\ub294 \uc81c3\uc790 \uacf5\uc778 \uac10\uc0ac \uae30\uad00\uc744 \ud1b5\ud55c \uc2dc\ud5d8 \ubc0f \uc778\uc99d\uc758 \ud544\uc694\uc131\uc744 \uac15\uc870\ud558\uba70, \uc2dc\uc7a5\uc758 \uc804\ubc18\uc801\uc778 \ubc94\uc704\uc640 \uc815\uc758\ub97c \ub2e4\ub8f9\ub2c8\ub2e4.<\/p>\n<p>\uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \ubc0f \uc778\uc99d \uc2dc\uc7a5\uc740 2026\ub144 109\uc5b5 5\ucc9c\ub9cc \ub2ec\ub7ec \uaddc\ubaa8\uc5d0\uc11c 2031\ub144\uae4c\uc9c0 131\uc5b5 5\ucc9c\ub9cc \ub2ec\ub7ec\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ub429\ub2c8\ub2e4. \ud2b9\ud788 \uc544\uc2dc\uc544-\ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc740 \uc911\uad6d\uacfc \uc778\ub3c4\uc758 \uaddc\uc81c \uac15\ud654\uc5d0 \ud798\uc785\uc5b4 \uc5f0\ud3c9\uade0 6.42%\ub85c \uac00\uc7a5 \ube60\ub978 \uc131\uc7a5\uc744 \ubcf4\uc77c \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc11c\ube44\uc2a4 \uc720\ud615\ubcc4\ub85c\ub294 \uc0dd\uccb4 \uc801\ud569\uc131, \uba78\uade0 \ubc0f \uc0ac\uc774\ubc84 \ubcf4\uc548 \ud14c\uc2a4\ud2b8\ub97c \ud3ec\ud568\ud558\ub294 \uc2dc\ud5d8 \uc11c\ube44\uc2a4\uac00 2025\ub144 \uc2dc\uc7a5 \uc810\uc720\uc728\uc758 55.98%\ub97c \ucc28\uc9c0\ud558\uba70 \uac00\uc7a5 \ud070 \ube44\uc911\uc744 \ucc28\uc9c0\ud588\uc2b5\ub2c8\ub2e4. \uae30\uae30 \ub4f1\uae09\ubcc4\ub85c\ub294 \ub192\uc740 \uc0dd\uc0b0\ub7c9\uacfc \uc911\uac04\uc5d0\uc11c \ub192\uc740 \uc218\uc900\uc758 \uaddc\uc81c \uc99d\uba85 \uc694\uad6c\uc0ac\ud56d\uc744 \uacb0\ud569\ud55c Class II \uae30\uae30\uac00 \uc608\uce21 \uae30\uac04 \ub3d9\uc548 \uc544\uc6c3\uc18c\uc2f1 \ud14c\uc2a4\ud2b8 \uc218\uc694\uc758 \ud575\uc2ec \ub3d9\ub825\uc73c\ub85c \uc791\uc6a9\ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p>\uc2dc\uc7a5\uc758 \uc131\uc7a5\uc744 \uacac\uc778\ud558\ub294 \uc8fc\uc694 \uc694\uc778\ub4e4\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. EU MDR(\uc720\ub7fd \uc758\ub8cc\uae30\uae30 \uaddc\uc815) \ubc0f FDA Safer Devices Act(\ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d \uc548\uc804 \uae30\uae30\ubc95)\uc5d0 \ub530\ub978 \uaddc\uc81c \uac15\ud654, \uc778\uacf5\uc9c0\ub2a5(AI) \ubc0f \uba38\uc2e0\ub7ec\ub2dd(ML) \uae30\ubc18 \uae30\uae30\uc758 \ud655\uc0b0\uc73c\ub85c \uc778\ud55c \uc804\ubb38\ud654\ub41c \uc720\ud6a8\uc131 \uac80\uc0ac \uc218\uc694 \uc99d\ub300, \uc7ac\ud0dd \ubc0f \uc6e8\uc5b4\ub7ec\ube14 \uc9c4\ub2e8 \uae30\uae30\uc758 \ubcf4\uae09 \ud655\ub300\uc5d0 \ub530\ub978 \ud14c\uc2a4\ud2b8 \ubb3c\ub7c9 \uc99d\uac00\uac00 \uc788\uc2b5\ub2c8\ub2e4. \ud2b9\ud788 2024\ub144 FDA\uc758 \uc2dc\ud310 \uc804 \uc0ac\uc774\ubc84 \ubcf4\uc548 \uc81c\ucd9c \uc758\ubb34\ud654 \ubc0f UL 2900 \ud45c\uc900\uc758 \uad11\ubc94\uc704\ud55c \ucc44\ud0dd\uc73c\ub85c \uc0ac\uc774\ubc84 \ubcf4\uc548 \ud14c\uc2a4\ud2b8 \uc11c\ube44\uc2a4\ub294 \uc5f0\ud3c9\uade0 5.83%\ub85c \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \ub610\ud55c, ESG(\ud658\uacbd, \uc0ac\ud68c, \uc9c0\ubc30\uad6c\uc870) \uc911\uc2ec\uc758 \uc9c0\uc18d\uac00\ub2a5\uc131 \uac10\uc0ac \uc694\uad6c\uac00 \uc870\ub2ec \uae30\uc900\uc73c\ub85c \ubd80\uc0c1\ud558\uace0 \uc788\uc73c\uba70, \uc0dd\uccb4 \uc758\ud559 \uae30\uc220 \uc778\ub825\uc758 \uae30\uc220 \uaca9\ucc28 \ud574\uc18c\ub97c \uc704\ud55c \uc778\uc99d \uc218\uc694\ub3c4 \uc99d\uac00\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubc18\uba74, \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uc800\ud574\ud558\ub294 \uc694\uc778\ub4e4\ub3c4 \uc874\uc7ac\ud569\ub2c8\ub2e4. \uacf5\uc778 \uae30\uad00(Notified Bodies)\uc758 \uc81c\ud55c\ub41c \uc5ed\ub7c9\uacfc \uae34 \ub9ac\ub4dc \ud0c0\uc784, \uc911\uc18c\uae30\uc5c5 \ubc0f \uc2a4\ud0c0\ud2b8\uc5c5\uc5d0\uac8c \ubd80\ub2f4\uc774 \ub418\ub294 \ub192\uc740 \ud14c\uc2a4\ud2b8 \ube44\uc6a9, AI \uc54c\uace0\ub9ac\uc998 \uc720\ud6a8\uc131 \uac80\uc99d\uc5d0 \ud544\uc694\ud55c \ud45c\uc900\ud654\ub41c \ub370\uc774\ud130\uc14b\uc758 \ud76c\uc18c\uc131, \uadf8\ub9ac\uace0 \uc9c0\uc18d\uac00\ub2a5\uc131 \uaddc\uc815 \uc900\uc218 \uc694\uad6c\uc0ac\ud56d\uc758 \ud30c\ud3b8\ud654 \ub4f1\uc774 \uc2dc\uc7a5\uc758 \uc81c\uc57d \uc694\uc778\uc73c\ub85c \uc791\uc6a9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubcf8 \ubcf4\uace0\uc11c\ub294 \uc2dc\uc7a5\uc744 \uc11c\ube44\uc2a4 \uc720\ud615(\uc2dc\ud5d8, \uc778\uc99d, \uac80\uc0ac \ubc0f \uac10\uc0ac \ub4f1), \uae30\uae30 \ub4f1\uae09(Class I, Class II, Class III, \uccb4\uc678 \uc9c4\ub2e8 \uae30\uae30), \ud14c\uc2a4\ud2b8 \uc720\ud615(\uc0dd\uccb4 \uc801\ud569\uc131, \uba78\uade0 \ubc0f \ubbf8\uc0dd\ubb3c, \uc804\uae30 \uc548\uc804 \ubc0f EMC, \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ubc0f \uc0ac\uc774\ubc84 \ubcf4\uc548, \uae30\uacc4 \ubc0f \ubb3c\ub9ac\uc801, \ud3ec\uc7a5 \ubc0f \uc720\ud6a8 \uae30\uac04 \ud14c\uc2a4\ud2b8 \ub4f1), \uadf8\ub9ac\uace0 \uc9c0\uc5ed(\ubd81\ubbf8, \uc720\ub7fd, \uc544\uc2dc\uc544-\ud0dc\ud3c9\uc591, \ub0a8\ubbf8, \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74)\ubcc4\ub85c \uc138\ubd84\ud654\ud558\uc5ec \ubd84\uc11d\ud569\ub2c8\ub2e4.<\/p>\n<p>\uacbd\uc7c1 \ud658\uacbd \ubd84\uc11d\uc5d0\uc11c\ub294 \uc2dc\uc7a5 \uc9d1\uc911\ub3c4, \uc2dc\uc7a5 \uc810\uc720\uc728 \ubd84\uc11d\uc744 \ud3ec\ud568\ud558\uba70, SGS SA, Intertek Group plc, T\u00dcV S\u00dcD, UL Solutions, Eurofins Scientific, BSI Group \ub4f1 \uc8fc\uc694 \uae30\uc5c5\ub4e4\uc758 \ud504\ub85c\ud544\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \ub610\ud55c, \ubcf4\uace0\uc11c\ub294 \uc2dc\uc7a5\uc758 \ubbf8\uac1c\ucc99 \uc601\uc5ed(white-space) \ubc0f \ubbf8\ucda9\uc871 \uc218\uc694(unmet-need)\uc5d0 \ub300\ud55c \ud3c9\uac00\ub97c \ud1b5\ud574 \ubbf8\ub798 \uc2dc\uc7a5 \uae30\ud68c\ub97c \uc81c\uc2dc\ud569\ub2c8\ub2e4.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-33877","post","type-post","status-publish","format-standard","hentry","category-market-reports"],"_links":{"self":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts\/33877"}],"collection":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/comments?post=33877"}],"version-history":[{"count":0,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts\/33877\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/media?parent=33877"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/categories?post=33877"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/tags?post=33877"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}