{"id":59416,"date":"2026-02-26T19:56:19","date_gmt":"2026-02-26T19:56:19","guid":{"rendered":"https:\/\/www.globalresearch.co.kr\/insight\/medical-device-testing-services-market-mordor\/"},"modified":"2026-09-04T01:57:38","modified_gmt":"2026-09-03T16:57:38","slug":"medical-device-testing-services-market-mordor","status":"publish","type":"post","link":"https:\/\/www.globalresearch.co.kr\/insight\/medical-device-testing-services-market-mordor\/","title":{"rendered":"\uc138\uacc4\uc758 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc810\uc720\uc728 \ubd84\uc11d &#8211; \uc131\uc7a5 \ub3d9\ud5a5 \ubc0f \uc804\ub9dd (2025 &#8211; 2030)"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/www.globalresearch.co.kr\/insight\/wp-content\/uploads\/2026\/02\/medical-device-testing-services-market-1752674263896-major-players.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-services-market-size-image-1752674004201.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 \ubc0f \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 \ud604\ud669<\/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 \uc544\uc6c3\uc18c\uc2f1 \ud14c\uc2a4\ud2b8\ub97c \uac00\uc18d\ud654\ud558\ub294 \uc5c4\uaca9\ud55c \uae00\ub85c\ubc8c \uaddc\uc81c \uc694\uad6c\uc0ac\ud56d<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.2 \ubcf5\uc7a1\ud55c \uc774\uc2dd\ud615 \uae30\uae30 &amp; \uc6e8\uc5b4\ub7ec\ube14 \uae30\uae30\uc758 \uae09\uc18d\ud55c \uc131\uc7a5<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.3 \ub9cc\uc131 \uc9c8\ud658 \ud658\uc790 \uc99d\uac00\ub85c \uc778\ud55c \uae30\uae30 \ubb3c\ub7c9 \uc99d\ub300<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.4 \uc81c\ud488 \uc218\uba85 \uc8fc\uae30 \ub2e8\ucd95\uc73c\ub85c \uc778\ud55c \ud14c\uc2a4\ud2b8 \ucc98\ub9ac\ub7c9 \uc555\ub825<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.5 EU-MDR \uc2dc\ud310 \ud6c4 \uac10\uc2dc \uaddc\uc815\uc774 \uc2e4\uc81c \uc131\ub2a5 \ud14c\uc2a4\ud2b8\ub97c \uc8fc\ub3c4<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.2.6 \uc758\ub8cc\uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc5d0 \ub300\ud55c \uc0ac\uc774\ubc84 \ubcf4\uc548 &amp; AI \uc54c\uace0\ub9ac\uc998 \uac80\uc99d<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          4.3 \uc2dc\uc7a5 \uc81c\uc57d \uc694\uc778<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          4.3.1 \ub2e4\uc911 \ubaa8\ub4dc \ud14c\uc2a4\ud2b8 \ud328\ub110\uc758 \ube44\uc6a9 &amp; \ucc98\ub9ac \uc2dc\uac04 \uc99d\uac00<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.3.2 \uc2e0\ud765 \uc9c0\uc5ed\uc758 ISO-17025 \uc900\uc218 \uc2e4\ud5d8\uc2e4 \uc5ed\ub7c9 \ubd80\uc871<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.3.3 \ub370\uc774\ud130 \ubb34\uacb0\uc131\uc5d0 \ub300\ud55c FDA \uacbd\uace0\ub85c \uc778\ud55c \uace0\ube44\uc6a9 \uc7ac\ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.3.4 \uc778\uc2e4\ub9ac\ucf54 \uc2dc\ubbac\ub808\uc774\uc158 \ucc44\ud0dd\uc73c\ub85c \uc778\ud55c \ud2b9\uc815 \uc2b5\uc2dd \uc2e4\ud5d8\uc2e4 \uc218\uc775 \uac10\uc18c<\/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 \ubd84\uc11d<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          4.7.1 \uacf5\uae09\uc5c5\uccb4\uc758 \uad50\uc12d\ub825<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.7.2 \uad6c\ub9e4\uc790\uc758 \uad50\uc12d\ub825<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          4.7.3 \uc2e0\uaddc \uc9c4\uc785\uc790\uc758 \uc704\ud611<\/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 \ubc0f \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 \uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.1.2 \uba78\uade0 \ubc0f \ubbf8\uc0dd\ubb3c \ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.1.3 \uc7ac\ub8cc \ud2b9\uc131 \ubd84\uc11d \ubc0f \ubd84\uc11d \ud654\ud559<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.1.4 \uc804\uae30 \uc548\uc804 \ubc0f EMC \ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.1.5 \ud3ec\uc7a5 \ubc0f \uc720\ud1b5 \uae30\ud55c \ud14c\uc2a4\ud2b8<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.1.6 \uae30\ud0c0<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          5.2 \uac1c\ubc1c \ub2e8\uacc4\ubcc4<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          5.2.1 \uc804\uc784\uc0c1<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.2.2 \uc784\uc0c1<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.2.3 \uc2dc\ud310 \ud6c4 \/ PMS<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          5.3 \uae30\uae30 \ub4f1\uae09\ubcc4<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          5.3.1 1\ub4f1\uae09<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.3.2 2\ub4f1\uae09<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.3.3 3\ub4f1\uae09<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          5.4 \ucd5c\uc885 \uc0ac\uc6a9\uc790\ubcc4<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          5.4.1 \uc758\ub8cc\uae30\uae30 OEM<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.4.2 \uacc4\uc57d \uc81c\uc870 \uc870\uc9c1 (CMO)<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.4.3 \uacc4\uc57d \uc5f0\uad6c \uc870\uc9c1 (CRO)<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.4.4 \uae30\ud0c0<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">\n          5.5 \uc9c0\uc5ed\ubcc4<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          5.5.1 \ubd81\ubbf8<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.1.1 \ubbf8\uad6d<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.1.2 \uce90\ub098\ub2e4<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.1.3 \uba55\uc2dc\ucf54<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.5.2 \uc720\ub7fd<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.2.1 \ub3c5\uc77c<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.2.2 \uc601\uad6d<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.2.3 \ud504\ub791\uc2a4<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.2.4 \uc774\ud0c8\ub9ac\uc544<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.2.5 \uc2a4\ud398\uc778<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.2.6 \uc720\ub7fd \uae30\ud0c0<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.5.3 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.3.1 \uc911\uad6d<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.3.2 \uc77c\ubcf8<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.3.3 \uc778\ub3c4<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.3.4 \ud638\uc8fc<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.3.5 \ub300\ud55c\ubbfc\uad6d<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.3.6 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uae30\ud0c0<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.5.4 \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.4.1 GCC<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.4.2 \ub0a8\uc544\ud504\ub9ac\uce74<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.4.3 \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74 \uae30\ud0c0<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          5.5.5 \ub0a8\ubbf8<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.5.1 \ube0c\ub77c\uc9c8<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.5.2 \uc544\ub974\ud5e8\ud2f0\ub098<\/p>\n<\/li>\n<li class=\"toc-level-4\">\n          5.5.5.3 \ub0a8\ubbf8 \uae30\ud0c0<\/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 \uc218\uc900 \uac1c\uc694, \uc2dc\uc7a5 \uc218\uc900 \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 \ubc0f \uc11c\ube44\uc2a4, \ucd5c\uadfc \uac1c\ubc1c \ud3ec\ud568)<\/p>\n<ul>\n<li class=\"toc-level-3\">\n          6.3.1 Eurofins Scientific<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.2 SGS SA<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.3 Intertek Group plc<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.4 T\u00dcV S\u00dcD AG<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.5 WuXi AppTec<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.6 NAMSA<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.7 Nelson Labs<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.8 UL Solutions \/ Emergo<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.9 Smithers<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.10 Element Materials Technology<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.11 Charles River Laboratories<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.12 T\u00dcV Rheinland<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.13 SGS-Brightsight<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.14 MCRA<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.15 Bureau Veritas<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.16 Tentamus Group<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.17 BSI Group<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.18 Labcorp<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.19 Veranex<\/p>\n<\/li>\n<li class=\"toc-level-3\">\n          6.3.20 Medistri<\/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 \ubc0f \ubbf8\ub798 \uc804\ub9dd<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc131\uc7a5 \ub3d9\ud5a5 \ubcf4\uace0\uc11c (2025-2030)<\/p>\n<p># \uc2dc\uc7a5 \uac1c\uc694<\/p>\n<p>\uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc740 2025\ub144 100\uc5b5 2\ucc9c\ub9cc \ub2ec\ub7ec \uaddc\ubaa8\uc5d0\uc11c 2030\ub144\uae4c\uc9c0 157\uc5b5 9\ucc9c\ub9cc \ub2ec\ub7ec\uc5d0 \ub3c4\ub2ec\ud558\uba70, \uc608\uce21 \uae30\uac04 \ub3d9\uc548 \uc5f0\ud3c9\uade0 9.52%\uc758 \uacac\uace0\ud55c \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ub429\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc131\uc7a5\uc740 \uc8fc\ub85c \uc804 \uc138\uacc4\uc801\uc73c\ub85c \uac15\ud654\ub418\ub294 \uaddc\uc81c, \uc778\uacf5\uc9c0\ub2a5(AI) \uae30\ubc18 \uc774\uc2dd\ud615 \uae30\uae30 \ubc0f \uc5f0\uacb0\ud615 \uc6e8\uc5b4\ub7ec\ube14 \uae30\uae30\uc758 \uae09\uc99d, \ub9cc\uc131 \uc9c8\ud658 \ud658\uc790 \uc99d\uac00, \uadf8\ub9ac\uace0 \uc81c\ud488 \uc218\uba85 \uc8fc\uae30\uc758 \ub2e8\ucd95\uc73c\ub85c \uc778\ud55c \uc2dc\ud5d8 \ucc98\ub9ac\ub7c9 \uc555\ubc15\uc5d0 \uae30\uc778\ud569\ub2c8\ub2e4. \ud2b9\ud788 FDA\uc758 \uc0ac\uc774\ubc84 \ubcf4\uc548 \uc758\ubb34\ud654\uc640 \uc720\ub7fd \uc5f0\ud569\uc758 \uc758\ub8cc\uae30\uae30 \uaddc\uc815(EU-MDR)\uc740 \uc81c\uc870\uc5c5\uccb4\ub4e4\uc774 \uacf5\uc778\ub41c \uc2dc\uc124, \ub2e4\ud559\uc81c\uc801 \uc778\ub825, \uc9c0\uc18d\uc801\uc73c\ub85c \uc5c5\ub370\uc774\ud2b8\ub418\ub294 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc744 \uac16\ucd98 \uc678\ubd80 \uc804\ubb38 \uae30\uad00\uc5d0 \uc758\uc874\ud558\uac8c \ub9cc\ub4e4\uba74\uc11c \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uac00\uc18d\ud654\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubc18\uba74, \ub2e4\uc911 \ubaa8\ub4dc \uc2dc\ud5d8 \ud328\ub110\uc758 \ube44\uc6a9 \ubc0f \uc18c\uc694 \uc2dc\uac04 \uc99d\uac00, \uc2e0\ud765 \uc9c0\uc5ed\uc758 ISO-17025 \uc900\uc218 \uc2e4\ud5d8\uc2e4 \uc5ed\ub7c9 \ubd80\uc871, FDA\uc758 \ub370\uc774\ud130 \ubb34\uacb0\uc131 \uacbd\uace0\ub85c \uc778\ud55c \uc7ac\uc2dc\ud5d8 \ubc1c\uc0dd, \uadf8\ub9ac\uace0 \uc778\uc2e4\ub9ac\ucf54(in-silico) \uc2dc\ubbac\ub808\uc774\uc158 \ub3c4\uc785\uc73c\ub85c \uc778\ud55c \uc77c\ubd80 \uc2b5\uc2dd \uc2e4\ud5d8\uc2e4 \uc218\uc775 \uac10\uc18c\ub294 \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uc5b5\uc81c\ud558\ub294 \uc694\uc778\uc73c\ub85c \uc791\uc6a9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p># \uc8fc\uc694 \ubcf4\uace0\uc11c \uc694\uc57d<\/p>\n<p>*   \uc11c\ube44\uc2a4 \uc720\ud615\ubcc4: \uc0dd\uccb4 \uc801\ud569\uc131 \uc2dc\ud5d8\uc774 2024\ub144 \uc2dc\uc7a5 \uc810\uc720\uc728\uc758 29.56%\ub97c \ucc28\uc9c0\ud558\uba70 \uac00\uc7a5 \ud070 \ube44\uc911\uc744 \ubcf4\uc600\uc73c\uba70, \uc804\uae30 \uc548\uc804 \ubc0f EMC(\uc804\uc790\uae30 \ud638\ud658\uc131) \uc2dc\ud5d8\uc740 2030\ub144\uae4c\uc9c0 13.44%\uc758 \uac00\uc7a5 \ube60\ub978 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<br \/>\n*   \uac1c\ubc1c \ub2e8\uacc4\ubcc4: \uc804\uc784\uc0c1 \ud504\ub85c\ud1a0\ucf5c\uc774 2024\ub144 \uc2dc\uc7a5 \uaddc\ubaa8\uc758 44.56%\ub97c \ucc28\uc9c0\ud558\uba70 \uc9c0\ubc30\uc801\uc774\uc5c8\uace0, \uc2dc\ud310 \ud6c4 \uac10\uc2dc \uc2dc\ud5d8\uc740 2030\ub144\uae4c\uc9c0 12.78%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\ub85c \ube60\ub974\uac8c \uc131\uc7a5\ud560 \uac83\uc785\ub2c8\ub2e4.<br \/>\n*   \uae30\uae30 \ub4f1\uae09\ubcc4: Class II \uae30\uae30\uac00 2024\ub144 \uc804 \uc138\uacc4 \uc2dc\ud5d8 \uc218\uc694\uc758 51.24%\ub97c \ucc28\uc9c0\ud588\uc73c\uba70, Class III \uae30\uae30 \uc2dc\ud5d8\uc740 2030\ub144\uae4c\uc9c0 13.77%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\ub85c \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ub429\ub2c8\ub2e4.<br \/>\n*   \ucd5c\uc885 \uc0ac\uc6a9\uc790\ubcc4: \uc758\ub8cc\uae30\uae30 \uc6d0\uc81c\uc870\uc0ac(OEM)\uac00 2024\ub144 \uc804\uccb4 \uc218\uc694\uc758 56.73%\ub97c \ucc3d\ucd9c\ud588\uc73c\uba70, \uacc4\uc57d \uc5f0\uad6c \uae30\uad00(CRO)\uc740 2030\ub144\uae4c\uc9c0 11.83%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\ub85c \ud655\uc7a5\ub420 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<br \/>\n*   \uc9c0\uc5ed\ubcc4: \ubd81\ubbf8\uac00 2024\ub144 \ub9e4\ucd9c \uc810\uc720\uc728\uc758 36.58%\ub97c \uc720\uc9c0\ud558\uba70 \uac00\uc7a5 \ud070 \uc2dc\uc7a5\uc774\uc5c8\uc73c\ub098, \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc740 \uc608\uce21 \uae30\uac04 \ub3d9\uc548 12.04%\uc758 \uac00\uc7a5 \uac15\ub825\ud55c \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p># \uc2dc\uc7a5 \ub3d9\ud5a5 \ubc0f \ud1b5\ucc30<\/p>\n<p> \uc131\uc7a5 \ub3d9\uc778<\/p>\n<p>1.  \uc5c4\uaca9\ud55c \uae00\ub85c\ubc8c \uaddc\uc81c \uc694\uad6c\uc0ac\ud56d \uac00\uc18d\ud654: FDA\uc758 2024\ub144 3\uc6d4 \uc0ac\uc774\ubc84 \ubcf4\uc548 \uc5c5\ub370\uc774\ud2b8\ub294 \ubaa8\ub4e0 \uc5f0\uacb0\ud615 \uae30\uae30\uc5d0 \ub300\ud55c \uc0c1\uc138\ud55c \ubcf4\uc548 \uac1c\ubc1c \ubb38\uc11c, \ucde8\uc57d\uc131 \ud3c9\uac00 \ubc0f \uc704\ud5d8 \uad00\ub9ac \ub9e4\ud2b8\ub9ad\uc2a4 \uc81c\ucd9c\uc744 \uc758\ubb34\ud654\ud558\uc5ec \uc2dc\ud5d8 \ubc94\uc704\ub97c \ud655\uc7a5\ud588\uc2b5\ub2c8\ub2e4. \ub3d9\uc2dc\uc5d0 EU-MDR\uc740 \ub808\uac70\uc2dc \uc81c\ud488 \uc804\ud658 \uae30\uac04\uc744 2028\ub144\uae4c\uc9c0 \uc5f0\uc7a5\ud588\uc9c0\ub9cc, \uc2e4\uc81c \uc99d\uac70 \uc758\ubb34\uc640 \uc5c4\uaca9\ud55c \uc778\uc99d \uae30\uad00 \uac10\ub3c5\uc744 \ubd80\uacfc\ud558\uc5ec \uc81c\uc870\uc5c5\uccb4\uc758 \uc790\uc6d0\uc744 \uc555\ubc15\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. ISO 17025\ub97c \uc900\uc218\ud558\uace0 \uc804\ubb38\ud654\ub41c \uc2dc\uc124\uc744 \uac16\ucd98 \uc81c3\uc790 \uacf5\uc778 \uc2e4\ud5d8\uc2e4\uc740 \uc774\ub7ec\ud55c \uaddc\uc81c \ubcf5\uc7a1\uc131\uc744 \ud574\uacb0\ud558\ub294 \ub370 \ud575\uc2ec\uc801\uc778 \uc5ed\ud560\uc744 \ud558\uba70, \uc81c\uc870\uc5c5\uccb4\ub4e4\uc740 \ucd9c\uc2dc \uc77c\uc815\uc744 \ub9de\ucd94\uae30 \uc704\ud574 \uc678\ubd80 \uc2dc\ud5d8 \uc11c\ube44\uc2a4\uc5d0 \ub300\ud55c \uc9c0\ucd9c\uc744 \ub298\ub9ac\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n2.  \ubcf5\uc7a1\ud55c \uc774\uc2dd\ud615 \ubc0f \uc6e8\uc5b4\ub7ec\ube14 \uae30\uae30\uc758 \uae09\uc99d: \uc13c\uc11c, AI \ubc0f \ubb34\uc120 \ubaa8\ub4c8\uc744 \uc18c\ud615 \ud3fc\ud329\ud130\uc5d0 \ud1b5\ud569\ud55c \ub2e4\uae30\ub2a5 \uae30\uae30\ub294 \uc0dd\uccb4 \uc801\ud569\uc131, EMC \ubc0f \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac80\uc99d\uc744 \ub3d9\uc2dc\uc5d0 \uc694\uad6c\ud569\ub2c8\ub2e4. FDA\ub294 AI \uae30\ubc18 \uc9c4\ub2e8 \uae30\uae30 \uc2a4\ud3f0\uc11c\uc5d0\uac8c \uc131\ubcc4, \ubbfc\uc871\uc131 \ubc0f \ub3d9\ubc18 \uc9c8\ud658 \uacc4\uce35 \uc804\ubc18\uc5d0 \uac78\uce5c \uc54c\uace0\ub9ac\uc998 \uc131\ub2a5\uc744 \uc785\uc99d\ud558\ub3c4\ub85d \uc9c0\uc2dc\ud558\uace0 \uc788\uc73c\uba70, IEC 60601-1-2 \uac1c\uc815 4\ud310\uc740 \uc804\ubb38, \uac00\uc815 \ubc0f \ud2b9\uc218 \ud658\uacbd\uc5d0 \ub300\ud55c \uba74\uc5ed \uc218\uc900\uc744 \uc758\ubb34\ud654\ud558\uc5ec \uc6e8\uc5b4\ub7ec\ube14 \ubc0f \uc774\uc2dd\ud615 \uae30\uae30\uc5d0 \ub300\ud55c \uc815\uad50\ud55c \ucc28\ud3d0 \ubc0f \uacf5\uc874 \uc2dc\ud5d8\uc744 \uac15\uc81c\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc778\ud504\ub77c\ub97c \ub0b4\ubd80\uc801\uc73c\ub85c \uac1c\ubc1c\ud558\ub294 \uac83\uc740 \uc790\ubcf8 \uc9d1\uc57d\uc801\uc774\ubbc0\ub85c, OEM\uc740 \uc678\ubd80 \uc804\ubb38\uac00\uc5d0\uac8c \ud504\ub85c\uadf8\ub7a8\uc744 \uc704\ud0c1\ud558\uc5ec \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uac15\ud654\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n3.  \ub9cc\uc131 \uc9c8\ud658 \ud658\uc790 \uc99d\uac00\ub85c \uc778\ud55c \uae30\uae30 \ubb3c\ub7c9 \uc99d\ub300: \uace0\ub839\ud654 \uc778\uad6c\uc640 \uc0dd\ud65c \uc2b5\uad00 \uad00\ub828 \uc9c8\ubcd1\uc740 \uc804 \uc138\uacc4\uc801\uc73c\ub85c \uae30\uae30 \uc18c\ube44\ub97c \uc99d\uac00\uc2dc\ud0a4\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc758 \uc758\ub8cc \uae30\uc220 \uc9c0\ucd9c\uc740 2030\ub144\uae4c\uc9c0 2,250\uc5b5 \ub2ec\ub7ec\uc5d0 \uc774\ub97c \uac83\uc73c\ub85c \uc608\uc0c1\ub418\uba70, \uc774\ub294 \ubcd1\uc6d0 \uac74\uc124, \ubcf4\ud5d8 \ud655\ub300 \ubc0f \ucd5c\uc18c \uce68\uc2b5 \uc2dc\uc220 \ucc44\ud0dd\uacfc \ub9de\ubb3c\ub824 \uc788\uc2b5\ub2c8\ub2e4. \ubb3c\ub7c9 \uc99d\uac00\ub294 \ub354 \ub9ce\uc740 \ubc30\uce58, \ub85c\ud2b8 \ubc0f \ubcc0\uacbd \uad00\ub9ac \uac80\uc99d\uc73c\ub85c \uc774\uc5b4\uc838 \uacf5\uc778 \uc2e4\ud5d8\uc2e4\uc5d0 \ub300\ud55c \uc218\uc694\ub97c \ud655\ub300\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. ISO, IEC \ubc0f IMDRF \ud45c\uc900\uacfc\uc758 \uc870\ud654\ub294 \ub2e4\uad6d\uc801 \uae30\uc5c5\uc774 \uc5ec\ub7ec \uc2dc\uc7a5\uc5d0\uc11c \ud558\ub098\uc758 \ubb38\uc11c\ub97c \ud65c\uc6a9\ud560 \uc218 \uc788\ub3c4\ub85d \ud558\uc5ec \uc2dc\ud5d8 \uc13c\ud130\uc758 \ucc98\ub9ac\ub7c9\uc744 \uc99d\uac00\uc2dc\ud0a4\uace0 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4\ub97c \ud544\uc218\uc801\uc778 \uc678\ubd80 \uc5ed\ub7c9\uc73c\ub85c \ud655\uace0\ud788 \ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n4.  \uc9e7\uc544\uc9c0\ub294 \uc81c\ud488 \uc218\uba85 \uc8fc\uae30\ub85c \uc778\ud55c \uc2dc\ud5d8 \ucc98\ub9ac\ub7c9 \uc555\ubc15: \ud074\ub77c\uc6b0\ub4dc \uc5f0\uacb0 \ubc0f SaMD(Software-as-Medical-Device) \ud328\ub7ec\ub2e4\uc784\uc740 \ubd84\uae30\ubcc4, \ub54c\ub85c\ub294 \uc6d4\ubcc4 \uae30\ub2a5 \ucd9c\uc2dc\ub97c \ucd09\uc9c4\ud569\ub2c8\ub2e4. FDA\uc758 \uc0ac\uc804 \uacb0\uc815\ub41c \ubcc0\uacbd \uad00\ub9ac \uacc4\ud68d \ud504\ub808\uc784\uc6cc\ud06c\ub294 \uc0ac\uc804 \uc2b9\uc778\ub41c \uac80\uc99d \uacbd\ub85c\ub97c \ub530\ub97c \uacbd\uc6b0 \uc0c8\ub85c\uc6b4 510(k) \uc5c6\uc774 \uc54c\uace0\ub9ac\uc998 \uc870\uc815\uc744 \ud5c8\uc6a9\ud558\uc9c0\ub9cc, \uc774\ub7ec\ud55c \uacbd\ub85c\ub294 \uc5ec\uc804\ud788 \uc0dd\uc0b0 \ubd80\ud558 \ud558\uc5d0\uc11c \uc131\ub2a5 \uc7ac\uac80\uc99d\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. \uc2a4\ud3f0\uc11c\ub294 \ubc18\ubcf5\uc801\uc778 \uc0ac\uc774\ubc84 \ubcf4\uc548 \uc2a4\uce94, \ud68c\uadc0 EMC \uc2a4\uc715 \ubc0f \uc7ac\uc2e4\ud589\ub41c \uc0dd\uccb4 \uc801\ud569\uc131 \ud3c9\uac00\ub97c \uc218\ud589\ud558\uae30 \uc704\ud574 \uc678\ubd80 \uc2dc\uc124\uc744 \ud655\uc7a5\ud558\uc5ec \uc2e0\uc18d\ud558\uace0 \ubc18\ubcf5 \uac00\ub2a5\ud55c \uc5ed\ub7c9\uc744 \uc704\ud574 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc5d0 \ub300\ud55c \uc758\uc874\ub3c4\ub97c \ub192\uc774\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p> \uc5b5\uc81c \uc694\uc778<\/p>\n<p>1.  \ub2e4\uc911 \ubaa8\ub4dc \uc2dc\ud5d8 \ud328\ub110\uc758 \ube44\uc6a9 \ubc0f \uc18c\uc694 \uc2dc\uac04 \uc99d\uac00: \ud655\uc7a5\ub41c \uc9c0\uce68\uc740 \uc0dd\uccb4 \uc801\ud569\uc131, \ud654\ud559\uc801 \ud2b9\uc131 \ubd84\uc11d, \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ubcf4\uc548 \ubc0f \uc804\uae30 \uc548\uc804\uc744 \ud558\ub098\uc758 \ubb38\uc11c\uc5d0 \ud1b5\ud569\ud558\ub3c4\ub85d \uc694\uad6c\ud558\uba70, \uc774\ub294 \ucd94\uac00 \uc7a5\ube44, \uc778\ub825 \uad50\uc721 \ubc0f \ubc29\ubc95 \uac80\uc99d\uc5d0 \ub300\ud55c \ud22c\uc790\ub97c \ud544\uc694\ub85c \ud569\ub2c8\ub2e4. ISO 10993-1\uc5d0 \ub530\ub978 FDA\uc758 \uc0dd\uccb4 \uc801\ud569\uc131 \uc815\ucc45\uc740 \ub3d9\ubb3c \uc0ac\uc6a9\uc744 \uc904\uc774\uba74\uc11c\ub3c4 \uc0c8\ub85c\uc6b4 *in-vitro* \ub3c5\uc131\ud559 \uc2a4\uc704\ud2b8 \ubc0f \uace0\ud568\ub7c9 \uc774\ubbf8\uc9d5 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \ud22c\uc790\ub97c \uac15\uc81c\ud558\uba70, \uc774\ub7ec\ud55c \ube44\uc6a9\uc740 \uad81\uadf9\uc801\uc73c\ub85c \uc2a4\ud3f0\uc11c\uc5d0\uac8c \uc804\uac00\ub429\ub2c8\ub2e4. \uc774\ub294 \uc911\uc18c\uae30\uc5c5\uc758 \uc608\uc0b0 \ubd80\ub2f4\uc744 \uac00\uc911\uc2dc\ucf1c \ub2e8\uae30\uc801\uc73c\ub85c \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc758 \uc77c\ubd80 \ubd80\ubb38\uc5d0\uc11c \ucc44\ud0dd\uc744 \ub2a6\ucd9c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n2.  \uc778\uc2e4\ub9ac\ucf54 \uc2dc\ubbac\ub808\uc774\uc158 \ub3c4\uc785\uc73c\ub85c \uc778\ud55c \uc77c\ubd80 \uc2b5\uc2dd \uc2e4\ud5d8\uc2e4 \uc218\uc775 \uac10\uc18c: \uace0\uc815\ubc00 \uc804\uc0b0 \ubaa8\ub378\uc740 \uc2e0\ub8b0\uc131\uc744 \uc704\ud574 \uac80\uc99d\ub420 \uacbd\uc6b0 \ud608\uc5ed\ud559, \uc815\ud615\uc678\uacfc \ubd80\ud558 \uacbd\ub85c \ub610\ub294 \uc804\uae30 \uc804\ud30c\ub97c \uaddc\uc81c \uc2b9\uc778\uacfc \ud568\uaed8 \ubcf5\uc81c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. FDA\uc758 \uac00\uc0c1 \uc784\uc0c1 \uc2dc\ud5d8 \uc2b9\uc778\uc740 \uc2a4\ud3f0\uc11c\uac00 \uc77c\ubd80 \ubca4\uce58 \ub610\ub294 \ub3d9\ubb3c \uc2e4\ud5d8\uc744 \ub300\uccb4\ud560 \uc218 \uc788\ub3c4\ub85d \ud5c8\uc6a9\ud558\uba70, \ud2b9\ud788 \uc810\uc9c4\uc801\uc778 \uc124\uacc4 \ubcc0\uacbd\uc758 \uacbd\uc6b0 \uc804\ud1b5\uc801\uc778 \uc2e4\ud5d8\uc2e4\uc758 \ucc98\ub9ac\ub7c9\uc744 \uac10\uc18c\uc2dc\ud0ac \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc2dc\ubbac\ub808\uc774\uc158 \uc11c\ube44\uc2a4\uc5d0 \ud22c\uc790\ud558\ub294 \uc2e4\ud5d8\uc2e4\uc740 \uc190\uc2e4\uc744 \uc0c1\uc1c4\ud560 \uc218 \uc788\uc9c0\ub9cc, \uc0c1\ud488\ud654\ub41c \uc2b5\uc2dd \uc2e4\ud5d8\uc2e4 \ubb3c\ub7c9\uc5d0 \ud06c\uac8c \uc758\uc874\ud558\ub294 \uacf5\uae09\uc5c5\uccb4\ub294 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \ub0b4\uc5d0\uc11c \ub354\ub518 \uc131\uc7a5\uc5d0 \uc9c1\uba74\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p># \uc138\uadf8\uba3c\ud2b8 \ubd84\uc11d<\/p>\n<p> \uc11c\ube44\uc2a4 \uc720\ud615\ubcc4: \uc0dd\uccb4 \uc801\ud569\uc131 \uc8fc\ub3c4, EMC \ucd94\uc6d4<\/p>\n<p>\uc0dd\uccb4 \uc801\ud569\uc131 \uc2dc\ud5d8\uc740 2024\ub144 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uc810\uc720\uc728\uc758 29.56%\ub97c \ucc28\uc9c0\ud558\uba70 \uc774 \ubd80\ubb38\uc758 \uc804\uccb4 \uc2dc\uc7a5 \uaddc\ubaa8\uc5d0 \uac00\uc7a5 \ud06c\uac8c \uae30\uc5ec\ud588\uc2b5\ub2c8\ub2e4. \ubaa8\ub4e0 \uc774\uc2dd\ud615, \uce68\uc2b5\ud615 \ub610\ub294 \uc7a5\uae30 \uc811\ucd09 \uc81c\ud488\uc740 \uaddc\uc81c \ub2f9\uad6d\uc774 \uc784\uc0c1 \ub370\uc774\ud130\ub97c \uc218\uc6a9\ud558\uae30 \uc804\uc5d0 \uc138\ud3ec \ub3c5\uc131, \uac10\uc791 \ubc0f \uc790\uadf9 \uc885\uc810\uc744 \ud1b5\uacfc\ud574\uc57c \ud558\ubbc0\ub85c \uc774 \uc11c\ube44\uc2a4\ub294 \uc5ec\uc804\ud788 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. \uc5f0\uacb0\ud615 \ud558\ub4dc\uc6e8\uc5b4 \ubc0f IEC 60601-1-2 \uba74\uc5ed \uac1c\uc815\uc5d0 \ud798\uc785\uc5b4 \uc804\uae30 \uc548\uc804 \ubc0f EMC \ud504\ub85c\ud1a0\ucf5c\uc740 2030\ub144\uae4c\uc9c0 13.44%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uba78\uade0 \ubc0f \ubbf8\uc0dd\ubb3c\ud559 \uc5f0\uad6c\ub294 \uc77c\ud68c\uc6a9\ud488 \ubc0f \uc815\ud615\uc678\uacfc \uc784\ud50c\ub780\ud2b8\uc5d0 \ud544\uc694\ud55c \uac80\uc99d\ub41c \uba78\uade0 \uc8fc\uae30\ub85c \uc778\ud574 \uafb8\uc900\ud55c \uc218\uc694\ub97c \uc720\uc9c0\ud558\uace0 \uc788\uc73c\uba70, \ubd84\uc11d \ud654\ud559\uc740 \uc2a4\ud3f0\uc11c\uac00 \ucd94\ucd9c\ubb3c, \uc6a9\ucd9c\ubb3c \ubc0f \uc7ac\ub8cc \uc0c1\ud638 \uc791\uc6a9\uc744 \uc870\uc0ac\ud568\uc5d0 \ub530\ub77c \uc911\uc694\uc131\uc774 \ucee4\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc0ac\uc774\ubc84 \ubcf4\uc548 \ubc0f AI \uc54c\uace0\ub9ac\uc998 \uac10\uc0ac\ub294 \uc544\uc9c1 \uc808\ub300\uc801\uc778 \uaddc\ubaa8\ub294 \uc791\uc9c0\ub9cc \uc138 \uc790\ub9bf\uc218 \ud504\ub85c\uc81d\ud2b8 \uc218\ub97c \uae30\ub85d\ud558\uace0 \uc788\uc73c\uba70, 2020\ub144\ub300 \uc911\ubc18\uae4c\uc9c0 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uaddc\ubaa8\uc758 \ub3c5\ub9bd\uc801\uc778 \ucd95\uc774 \ub420 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p> \uac1c\ubc1c \ub2e8\uacc4\ubcc4: \uc804\uc784\uc0c1 \uc9c0\ubc30, \uc2dc\ud310 \ud6c4 \uac10\uc2dc \uc99d\uac00<\/p>\n<p>\uc804\uc784\uc0c1 \uac80\uc99d\uc740 2024\ub144 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uc810\uc720\uc728\uc758 44.56%\ub97c \ucc28\uc9c0\ud558\uba70 \uc2dc\uc7a5 \uaddc\ubaa8\uc5d0 \uac00\uc7a5 \ud06c\uac8c \uae30\uc5ec\ud588\uc2b5\ub2c8\ub2e4. \uc2a4\ud3f0\uc11c\ub294 510(k), PMA \ubc0f CE \ub9c8\ud06c \uc81c\ucd9c\uc744 \uc9c0\uc6d0\ud558\uae30 \uc704\ud574 \ubca4\uce58\ud0d1 \uc131\ub2a5, \uc0dd\uccb4 \uc801\ud569\uc131, \uae30\uacc4\uc801 \ubc0f \ud654\ud559\uc801 \ud2b9\uc131 \ubd84\uc11d \ub370\uc774\ud130\uc5d0 \uc758\uc874\ud558\uc5ec \uc608\uce21 \uac00\ub2a5\ud55c \uc2e4\ud5d8\uc2e4 \ucc98\ub9ac\ub7c9\uc744 \uc0dd\uc131\ud569\ub2c8\ub2e4. \ubc18\uba74, \uc2dc\ud310 \ud6c4 \uac10\uc2dc \uc2dc\ud5d8\uc740 2030\ub144\uae4c\uc9c0 12.78%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\ub85c \ud655\uc7a5\ub420 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\uba70, \uc774\ub294 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uaddc\ubaa8\uc5d0\uc11c \ucc28\uc9c0\ud558\ub294 \ube44\uc911\uc744 \uafb8\uc900\ud788 \ub192\uc77c \uac83\uc785\ub2c8\ub2e4. EU-MDR\uc740 \ubaa8\ub4e0 \uc2dc\ud310 \uc758\ub8cc\uae30\uae30 \ub4f1\uae09\uc5d0 \ub300\ud55c \ucd94\uc138 \ubcf4\uace0, \uc8fc\uae30\uc801\uc778 \uc548\uc804 \uc5c5\ub370\uc774\ud2b8 \ubc0f \uc2dc\uc815 \uc870\uce58 \ud655\uc778\uc744 \uc758\ubb34\ud654\ud558\uc5ec \uc81c\uc870\uc5c5\uccb4\uac00 \uc2e4\uc81c \ub370\uc774\ud130 \ubd84\uc11d \ubc0f \ud6c4\uc18d \ubca4\uce58 \uc5f0\uad6c\ub97c \uc704\ud574 \uc678\ubd80 \ud30c\ud2b8\ub108\uc640 \uacc4\uc57d\ud558\ub3c4\ub85d \uc720\ub3c4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p> \uae30\uae30 \ub4f1\uae09\ubcc4: Class II \uc9c0\ubc30, Class III \uae09\uc99d<\/p>\n<p>Class II \uae30\uae30\ub294 2024\ub144 \uc804 \uc138\uacc4 \uc2dc\ud5d8 \uc9c0\ucd9c\uc758 51.24%\ub97c \ucc28\uc9c0\ud558\uba70 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uaddc\ubaa8\uc758 \uac00\uc7a5 \ud070 \ub3d9\uc778\uc774\uc5c8\uc2b5\ub2c8\ub2e4. \uc8fc\uc785 \ud38c\ud504, \uc218\uc220 \uc5d0\ub108\uc9c0 \uc2dc\uc2a4\ud15c \ubc0f \uc601\uc0c1 \uc561\uc138\uc11c\ub9ac\ub97c \ud3ec\ud568\ud55c \uc774\ub7ec\ud55c \uc911\uac04 \uc704\ud5d8 \uc81c\ud488\uc740 \ud2b9\ubcc4 \uad00\ub9ac\uc640 \ud3ec\uad04\uc801\uc778 \ubca4\uce58 \ubc0f \ub54c\ub85c\ub294 \uc81c\ud55c\uc801\uc778 \uc784\uc0c1 \uc99d\uac70\ub97c \uc694\uad6c\ud558\uc5ec \uafb8\uc900\ud55c \uc2e4\ud5d8\uc2e4 \uc218\uc694\ub97c \ucc3d\ucd9c\ud569\ub2c8\ub2e4. Class III \uc81c\ucd9c\uc740 \ub2e8\uc704 \uc218\ub294 \uc801\uc9c0\ub9cc 13.77%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\ub85c \ud655\uc7a5\ub418\uc5b4 2030\ub144\uae4c\uc9c0 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uc810\uc720\uc728\uc758 \uc99d\uac00\ud558\ub294 \ubd80\ubd84\uc744 \ucc28\uc9c0\ud560 \uac83\uc785\ub2c8\ub2e4. \uc2ec\uc2e4 \ubcf4\uc870 \uc7a5\uce58 \ub610\ub294 \uc2e0\uacbd \uc790\uadf9\uae30\uc640 \uac19\uc740 \uc0dd\uba85 \uc720\uc9c0 \uc774\uc2dd\ud615 \uae30\uae30\ub294 \uad11\ubc94\uc704\ud55c \uc804\uc784\uc0c1, \ub300\ub3d9\ubb3c, \uc778\uac04 \uc694\uc778 \ubc0f \uc2dc\ud310 \ud6c4 \ud504\ub85c\uadf8\ub7a8\uc744 \uc758\ubb34\ud654\ud558\uc5ec \uc911\uac04 \uc704\ud5d8 \uc81c\ud488\ubcf4\ub2e4 5~10\ubc30 \ub354 \ud070 \uc2dc\ud5d8 \uc608\uc0b0\uc744 \ud544\uc694\ub85c \ud569\ub2c8\ub2e4.<\/p>\n<p> \ucd5c\uc885 \uc0ac\uc6a9\uc790\ubcc4: OEM \uc9c0\ucd9c \uc8fc\ub3c4, CRO \uac00\uc18d\ud654<\/p>\n<p>\uc6d0\uc81c\uc870\uc0ac(OEM)\ub294 2024\ub144 \ub9e4\ucd9c\uc758 56.73%\ub97c \ucc28\uc9c0\ud558\uba70 \uc9c0\ubc30\uc801\uc778 \uace0\uac1d \uadf8\ub8f9\uc774\uc790 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uaddc\ubaa8\uc758 \uc8fc\uc694 \uacb0\uc815 \uc694\uc778\uc774\uc5c8\uc2b5\ub2c8\ub2e4. \uc774\ub4e4\uc758 \uae30\uc5c5 \ud488\uc9c8 \uc2dc\uc2a4\ud15c \ubc0f \uaddc\uc81c \uc81c\ucd9c \uc758\ubb34\ub294 \uc0dd\uccb4 \uc801\ud569\uc131, \uba78\uade0, EMC \ubc0f \uc0ac\uc774\ubc84 \ud3c9\uac00 \uc804\ubc18\uc5d0 \uac78\uce5c \uccb4\uacc4\uc801\uc778 \uc544\uc6c3\uc18c\uc2f1\uc744 \uac15\uc81c\ud569\ub2c8\ub2e4. \uacc4\uc57d \uc5f0\uad6c \uae30\uad00(CRO)\uc740 11.83%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\uba70, \uc2a4\ud3f0\uc11c\uac00 \ubca4\uce58, \ub3d9\ubb3c \ubc0f \uc784\uc0c1 \uc11c\ube44\uc2a4\ub97c \ub2e8\uc77c \ub9c8\uc2a4\ud130 \uacc4\uc57d\uc73c\ub85c \ud1b5\ud569\ud568\uc5d0 \ub530\ub77c \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5 \uc810\uc720\uc728\uc744 \ub192\uc77c \uac83\uc785\ub2c8\ub2e4. CRO\ub294 \uc2dc\ud5d8 \uc2e4\ud5d8\uc2e4\uc744 \uc778\uc218\ud558\uac70\ub098 \ud30c\ud2b8\ub108\uc2ed\uc744 \ub9fa\uc5b4 \uc694\ub78c\uc5d0\uc11c \uc0c1\uc5c5\ud654\uae4c\uc9c0\uc758 \ud328\ud0a4\uc9c0\ub97c \uc81c\uacf5\ud568\uc73c\ub85c\uc368 OEM\uc774 \uacf5\uae09\uc5c5\uccb4 \ubaa9\ub85d\uc744 \uac04\uc18c\ud654\ud558\uace0 \ucd9c\uc2dc \uc77c\uc815\uc744 \ub2e8\ucd95\ud560 \uc218 \uc788\ub3c4\ub85d \ud569\ub2c8\ub2e4.<\/p>\n<p># \uc9c0\uc5ed \ubd84\uc11d<\/p>\n<p>*   \ubd81\ubbf8: 2024\ub144 \uc804 \uc138\uacc4 \ub9e4\ucd9c\uc758 36.58%\ub97c \ucc28\uc9c0\ud558\uba70 \uac00\uc7a5 \ud070 \uc2dc\uc7a5\uc774\uc5c8\uc2b5\ub2c8\ub2e4. \uc5c4\uaca9\ud55c FDA \uac10\ub3c5, \uac15\ub825\ud55c \uc9c0\ubd88 \uc2dc\uc2a4\ud15c, \uadf8\ub9ac\uace0 \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc758 \ubaa8\ub4e0 \uc8fc\uc694 \ubaa8\ub2ec\ub9ac\ud2f0\ub97c \ud3ec\uad04\ud558\ub294 ISO \uacf5\uc778 \uc2e4\ud5d8\uc2e4\uc758 \ubc00\uc9d1\ub41c \ub124\ud2b8\uc6cc\ud06c\uac00 \uc774\ub97c \ub4b7\ubc1b\uce68\ud569\ub2c8\ub2e4. \ubbf8\uad6d\uc740 \uc0ac\uc774\ubc84 \ubcf4\uc548 \ubc0f AI \ubd84\uc57c\uc5d0\uc11c \uaddc\uc81c \ud601\uc2e0\uc744 \uc8fc\ub3c4\ud558\uc5ec \uc2a4\ud3f0\uc11c\uac00 \uc81c\uc870\uac00 \ud574\uc678\uc5d0 \uc788\ub354\ub77c\ub3c4 \uad6d\ub0b4 \uc2dc\ud5d8 \ud30c\uc774\ud504\ub77c\uc778\uc744 \uc720\uc9c0\ud558\ub3c4\ub85d \uac15\uc81c\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n*   \uc720\ub7fd: \ub450 \ubc88\uc9f8\ub85c \ud070 \uc9c0\uc5ed\uc73c\ub85c, \uc5f0\uc7a5\ub41c MDR \uc804\ud658 \uae30\uac04\uc73c\ub85c \uc778\ud574 \uc218\ucc9c \uac1c\uc758 \ub808\uac70\uc2dc \uae30\uae30\uac00 \uc801\ud569\uc131 \ud3c9\uac00 \ub300\uae30\uc5f4\uc5d0 \ub0a8\uc544 \uc788\uc5b4 T\u00dcV S\u00dcD, BSI \ubc0f DEKRA \uc2dc\uc124\uc758 \uc9c0\uc18d\uc801\uc778 \ud65c\uc6a9\uc744 \uc720\ub3c4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ub3c5\uc77c\uc774 \ubb3c\ub7c9 \uba74\uc5d0\uc11c \uc120\ub450\ub97c \ub2ec\ub9ac\uace0 \uc788\uc9c0\ub9cc, \uc601\uad6d\uacfc \ud504\ub791\uc2a4\ub294 \uc0ac\uc6a9\uc131, \uc778\uac04 \uc694\uc778 \ubc0f \ub514\uc9c0\ud138 \uac74\uac15 \uac80\uc99d\uc744 \uc704\ud55c \ud504\ub9ac\ubbf8\uc5c4 \uc13c\ud130\ub85c \ub0a8\uc544 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n*   \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591: 12.04%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud558\uba70 \ub2e4\ub978 \ubaa8\ub4e0 \uc9c0\uc5ed\uc744 \ub2a5\uac00\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc911\uad6d\uc758 \uc2dc\uc7a5 \uac10\ub3c5 \uad00\ub9ac \ucd1d\uad6d\uc740 \uae30\uae30 \ubd84\ub958 \uce74\ud0c8\ub85c\uadf8\ub97c \ud604\ub300\ud654\ud558\uace0 \ud604\uc9c0 \uc784\uc0c1 \ud3c9\uac00 \uc9c0\uce68\uc744 \uac15\ud654\ud558\uc5ec \uad6d\ub0b4 \uc2e4\ud5d8\uc2e4 \ud22c\uc790\ub97c \ub298\ub838\uc2b5\ub2c8\ub2e4. \uc77c\ubcf8\uc740 PMDA\uc758 \ud601\uc2e0 \uae30\uae30 \uc2e0\uc18d \uc2ec\uc0ac\ub97c \ud1b5\ud574 \ub192\uc740 \uae30\uc220 \uc218\uc694\ub97c \uc720\uc9c0\ud558\uc9c0\ub9cc, \uc885\uc885 \uc911\ubcf5\ub41c \uc0dd\uccb4 \uc801\ud569\uc131 \ub370\uc774\ud130\ub97c \uc694\uad6c\ud558\uc5ec \uc2dc\ud5d8 \ubb3c\ub7c9\uc744 \uc99d\uac00\uc2dc\ud0b5\ub2c8\ub2e4. \uc778\ub3c4\uc758 2024\ub144 \uc758\ub8cc\uae30\uae30 \uaddc\uc815\uc740 \uc774\uc804\uc5d0 \uaddc\uc81c\ub418\uc9c0 \uc54a\uc558\ub358 \ubc94\uc8fc\ub85c \uc758\ubb34 \ub77c\uc774\uc120\uc2a4\ub97c \ud655\ub300\ud558\uc5ec \ud604\uc9c0 \uc218\uc694\ub97c \uc790\uadf9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p># \uacbd\uc7c1 \ud658\uacbd<\/p>\n<p>\uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc740 \uc911\uac04 \uc815\ub3c4\uc758 \ud1b5\ud569\uc744 \ubcf4\uc785\ub2c8\ub2e4. Eurofins Scientific\uc740 2024\ub144 \uccab 9\uac1c\uc6d4 \ub3d9\uc548 51\uc5b5 4,200\ub9cc \uc720\ub85c\uc758 \ub9e4\ucd9c\uc744 \uae30\ub85d\ud588\uc73c\uba70, Infinity Laboratories\ub97c \uc778\uc218\ud558\uc5ec \ubbf8\uad6d \uc804\uc5ed\uc758 \ubbf8\uc0dd\ubb3c\ud559 \ubc0f \uba78\uade0 \uc5ed\ub7c9\uc744 \ud655\uc7a5\ud588\uc2b5\ub2c8\ub2e4. SGS\ub294 2025\ub144 7\uc6d4 Applied Technical Services\ub97c 13\uc5b5 2,500\ub9cc \ub2ec\ub7ec\uc5d0 \uc778\uc218\ud558\uc5ec \ubd81\ubbf8 \uc2dc\uc7a5 \uc785\uc9c0\ub97c \uac15\ud654\ud588\uc2b5\ub2c8\ub2e4. Intertek\uc740 \uc5f0\uacb0\ud615 \uae30\uae30\uc5d0 \uc911\uc810\uc744 \ub450\uace0 \ucd5c\uadfc \uce98\ub9ac\ud3ec\ub2c8\uc544\uc5d0 AI \ubcf4\uc548 \uc13c\ud130\ub97c \uac1c\uc124\ud588\uc73c\uba70, T\u00dcV S\u00dcD\ub294 \uc720\ub7fd, \uc544\uc2dc\uc544 \ubc0f \ubbf8\uad6d\uc5d0 \uac78\uccd0 \ub514\uc9c0\ud138 \uac74\uac15 \uc778\uc99d \ud504\ub85c\uadf8\ub7a8\uc744 \uac15\ud654\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc804\ub7b5\uc801 \uc778\uc218 \ud65c\ub3d9\uc740 \uacc4\uc18d\ub420 \uc870\uc9d0\uc744 \ubcf4\uc774\uace0 \uc788\uc2b5\ub2c8\ub2e4. Applus+\ub294 2024\ub144 11\uc6d4 Keystone Compliance\ub97c \uc778\uc218\ud558\uc5ec \uad70\uc6a9 \ub4f1\uae09 \ub0b4\uad6c\uc131 \uc2dc\ud5d8\uc5d0 \ud2b9\ud654\ub41c EMC \ubc0f \ud658\uacbd \ucc54\ubc84 \uc804\ubb38\uc131\uc744 \ud655\ubcf4\ud588\uc2b5\ub2c8\ub2e4. NAMSA\uc640 Terumo\uc758 \uc81c\ud734\ub294 \ub3c5\uc131\ud559, \uc784\uc0c1 \ubaa8\ub2c8\ud130\ub9c1 \ubc0f \uaddc\uc81c \ubb38\uc11c \uc791\uc131\uc744 \ub9c8\uc2a4\ud130 \uc11c\ube44\uc2a4 \ud504\ub808\uc784\uc6cc\ud06c \ud558\uc5d0 \ud1b5\ud569\ud558\ub294 \uc5d4\ub4dc\ud22c\uc5d4\ub4dc \uc544\uc6c3\uc18c\uc2f1\uc758 \uc804\ud615\uc744 \ubcf4\uc5ec\uc90d\ub2c8\ub2e4. Nelson Labs(\ubbf8\uc0dd\ubb3c\ud559), Element(\uc7ac\ub8cc) \ubc0f WuXi AppTec(\uc911\uad6d-FDA \uc774\uc911 \uc81c\ucd9c)\uacfc \uac19\uc740 \uc804\ubb38 \uacf5\uae09\uc5c5\uccb4\ub294 \ub300\uae30\uc5c5 \uaddc\ubaa8\uc758 \uc774\uc810\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0 \uae4a\uc774 \uc788\ub294 \ub3c4\uba54\uc778 \uc9c0\uc2dd\uc744 \ud65c\uc6a9\ud558\uc5ec \ub9c8\uc9c4\uc744 \ubc29\uc5b4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uae30\uc220\uc740 \uc0c8\ub85c\uc6b4 \ucc28\ubcc4\ud654 \uc694\uc18c\uc785\ub2c8\ub2e4. \uc2dc\uc7a5 \uc120\ub450 \uc8fc\uc790\ub4e4\uc740 \ub85c\ubd07 \ubcf4\uc870 \uc0d8\ud50c \uc900\ube44, \uc778\uacf5\uc9c0\ub2a5 \uacb0\uacfc \ud574\uc11d \ubc0f \uc554\ud638\ud654\ub41c \ud074\ub77c\uc6b0\ub4dc \ud3ec\ud138\uc5d0 \ub9c9\ub300\ud55c \ud22c\uc790\ub97c \ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ucd94\uc801\uc131\uc744 \uc790\ub3d9\ud654\ud558\uace0 \ub514\uc9c0\ud138 \ud2b8\uc708 \uc2dc\ubbac\ub808\uc774\uc158\uc744 \ud1b5\ud569\ud558\ub294 \uc2e4\ud5d8\uc2e4\uc740 \uc0ac\uc774\ud074 \uc2dc\uac04\uc744 \ub2e8\ucd95\ud558\uace0 \ud504\ub9ac\ubbf8\uc5c4 \uac00\uaca9\uc744 \ud655\ubcf4\ud558\ub294 \ubc18\uba74, \ub4a4\ucc98\uc9c0\ub294 \uae30\uc5c5\uc740 \uc0c1\ud488\ud654\ub41c \uc800\ub9c8\uc9c4 \uc0dd\uccb4 \ubd80\ub2f4 \uce21\uc815\uc73c\ub85c \uc804\ub77d\ud560 \uc704\ud5d8\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uacbd\uc7c1 \uc5ed\ud559\uc740 \uc9c0\uc18d\uc801\uc778 \uc790\ubcf8 \uc9c0\ucd9c \ubc0f \uc778\uc218 \ud65c\ub3d9\uc744 \ucd09\uc9c4\ud558\uc5ec \uc758\ub8cc\uae30\uae30 \uc2dc\ud5d8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc758 \ud601\uc2e0 \uada4\uc801\uc744 \ud615\uc131\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ucd5c\uadfc \uc0b0\uc5c5 \ub3d9\ud5a5:<br \/>\n*   2025\ub144 1\uc6d4: SGS\ub294 Applied Technical Services\ub97c 13\uc5b5 2,500\ub9cc \ub2ec\ub7ec\uc5d0 \uc778\uc218\ud558\uae30\ub85c \ud569\uc758\ud558\uc5ec \uc5f0\uac04 \ub9e4\ucd9c 15\uc5b5 \ub2ec\ub7ec\ub97c \ucd08\uacfc\ud558\ub294 \ubd81\ubbf8 \uc2dc\ud5d8 \ubc0f \uac80\uc0ac \ud50c\ub7ab\ud3fc\uc744 \uad6c\ucd95\ud588\uc2b5\ub2c8\ub2e4.<br \/>\n*   2024\ub144 11\uc6d4: Applus+\ub294 Keystone Compliance\ub97c \uc778\uc218\ud558\uc5ec \ubbf8\uad6d \ub0b4 \uc785\uc9c0\ub97c \uac15\ud654\ud558\uae30 \uc704\ud574 EMC\/EMI, \ud658\uacbd \ubc0f \ud3ec\uc7a5 \uc804\ubb38\uc131\uc744 \ucd94\uac00\ud588\uc2b5\ub2c8\ub2e4.<br \/>\n*   2024\ub144 10\uc6d4: NAMSA\uc640 Terumo\ub294 Terumo\uc758 \uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \ud30c\uc774\ud504\ub77c\uc778 \uc804\ubc18\uc5d0 \uac78\uccd0 \uaddc\uc81c \uc2b9\uc778\uc744 \uac00\uc18d\ud654\ud558\uae30 \uc704\ud55c \uc804\ub7b5\uc801 \uc544\uc6c3\uc18c\uc2f1 \ud30c\ud2b8\ub108\uc2ed\uc744 \uccb4\uacb0\ud588\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc774 \ubcf4\uace0\uc11c\ub294 \uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \ud14c\uc2a4\ud2b8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc5d0 \ub300\ud55c \ud3ec\uad04\uc801\uc778 \ubd84\uc11d\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc11c\ub860, \uc5f0\uad6c \ubc29\ubc95\ub860, \uc2dc\uc7a5 \ud658\uacbd, \uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc131\uc7a5 \uc608\uce21, \uacbd\uc7c1 \ud658\uacbd, \uc2dc\uc7a5 \uae30\ud68c \ubc0f \ubbf8\ub798 \uc804\ub9dd \ub4f1 \uc8fc\uc694 \ubaa9\ucc28\ub97c \ud3ec\ud568\ud558\uba70, \uc2dc\uc7a5\uc758 \uc804\ubc18\uc801\uc778 \ub3d9\ud5a5\uacfc \uc138\ubd80 \uc0ac\ud56d\uc744 \ub2e4\ub8f9\ub2c8\ub2e4. \ud2b9\ud788, \uc2dc\uc7a5 \uac1c\uc694, \ub3d9\uc778, \uc81c\uc57d \uc694\uc778, \uac00\uce58\/\uacf5\uae09\ub9dd \ubd84\uc11d, \uaddc\uc81c \ud658\uacbd, \uae30\uc220 \uc804\ub9dd, \uadf8\ub9ac\uace0 Porter\uc758 5\uac00\uc9c0 \uacbd\uc7c1 \uc694\uc778 \ubd84\uc11d\uc744 \ud1b5\ud574 \uc2dc\uc7a5 \ud658\uacbd\uc744 \uc2ec\uce35\uc801\uc73c\ub85c \uc870\uba85\ud569\ub2c8\ub2e4.<\/p>\n<p>\uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc131\uc7a5 \uc804\ub9dd:<br \/>\n\uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \ud14c\uc2a4\ud2b8 \uc11c\ube44\uc2a4 \uc2dc\uc7a5\uc740 2025\ub144\ubd80\ud130 2030\ub144\uae4c\uc9c0 \uc5f0\ud3c9\uade0 9.52%\uc758 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud558\uba70, 2025\ub144 100\uc5b5 2\ucc9c\ub9cc \ub2ec\ub7ec\uc5d0\uc11c 2030\ub144 157\uc5b5 9\ucc9c\ub9cc \ub2ec\ub7ec \uaddc\ubaa8\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc8fc\uc694 \uc2dc\uc7a5 \ub3d9\uc778:<br \/>\n\uc2dc\uc7a5\uc758 \uc131\uc7a5\uc744 \uacac\uc778\ud558\ub294 \uc8fc\uc694 \uc694\uc778\ub4e4\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<br \/>\n1.  \uc5c4\uaca9\ud55c \uae00\ub85c\ubc8c \uaddc\uc81c \uc694\uac74: \uc804 \uc138\uacc4\uc801\uc73c\ub85c \uac15\ud654\ub418\ub294 \uaddc\uc81c \uc694\uac74\uc774 \uc544\uc6c3\uc18c\uc2f1 \ud14c\uc2a4\ud2b8 \uc218\uc694\ub97c \uac00\uc18d\ud654\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n2.  \ubcf5\uc7a1\ud55c \uc774\uc2dd\ud615 \ubc0f \uc6e8\uc5b4\ub7ec\ube14 \uae30\uae30\uc758 \uae09\uc99d: \ubcf5\uc7a1\uc131\uc774 \ub192\uc740 \uc774\uc2dd\ud615 \uc758\ub8cc\uae30\uae30 \ubc0f \uc6e8\uc5b4\ub7ec\ube14 \uae30\uae30\uc758 \ube60\ub978 \uc131\uc7a5\uc774 \ud14c\uc2a4\ud2b8 \ud544\uc694\uc131\uc744 \uc99d\ub300\uc2dc\ud0b5\ub2c8\ub2e4.<br \/>\n3.  \ub9cc\uc131 \uc9c8\ud658 \ud658\uc790 \uc99d\uac00: \ub9cc\uc131 \uc9c8\ud658 \ud658\uc790 \ud480\uc758 \ud655\ub300\ub294 \uc758\ub8cc\uae30\uae30 \uc0dd\uc0b0\ub7c9 \uc99d\uac00\ub85c \uc774\uc5b4\uc838 \ud14c\uc2a4\ud2b8 \uc218\uc694\ub97c \ucd09\uc9c4\ud569\ub2c8\ub2e4.<br \/>\n4.  \uc81c\ud488 \uc218\uba85 \uc8fc\uae30\uc758 \ub2e8\ucd95: \uc81c\ud488 \uc218\uba85 \uc8fc\uae30\uac00 \uc9e7\uc544\uc9c0\uba74\uc11c \ud14c\uc2a4\ud2b8 \ucc98\ub9ac\ub7c9\uc5d0 \ub300\ud55c \uc555\ub825\uc774 \ucee4\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n5.  EU-MDR \uc2dc\ud310 \ud6c4 \uac10\uc2dc \uaddc\uc815: EU-MDR(\uc720\ub7fd \uc758\ub8cc\uae30\uae30 \uaddc\uc815)\uc758 \uc2dc\ud310 \ud6c4 \uac10\uc2dc(PMS) \uaddc\uce59\uc740 \uc81c\ud488 \uc218\uba85 \uc8fc\uae30 \uc804\ubc18\uc5d0 \uac78\uce5c \uc2e4\uc81c \uc131\ub2a5 \ub370\uc774\ud130 \uc218\uc9d1\uc744 \uc758\ubb34\ud654\ud558\uc5ec \ud14c\uc2a4\ud2b8\uc758 \uc911\uc694\uc131\uc744 \ubd80\uac01\uc2dc\ud0b5\ub2c8\ub2e4.<br \/>\n6.  \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc758\ub8cc\uae30\uae30(SaMD)\uc758 \uc0ac\uc774\ubc84 \ubcf4\uc548 \ubc0f AI \uc54c\uace0\ub9ac\uc998 \uac80\uc99d: \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud615\ud0dc\uc758 \uc758\ub8cc\uae30\uae30\uc5d0 \ub300\ud55c \uc0ac\uc774\ubc84 \ubcf4\uc548 \ubc0f AI \uc54c\uace0\ub9ac\uc998 \uac80\uc99d\uc758 \ud544\uc694\uc131\uc774 \ucee4\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc8fc\uc694 \uc2dc\uc7a5 \uc81c\uc57d \uc694\uc778:<br \/>\n\ubc18\uba74, \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uc800\ud574\ud558\ub294 \uc694\uc778\ub4e4\ub3c4 \uc874\uc7ac\ud569\ub2c8\ub2e4.<br \/>\n1.  \ub2e4\uc911 \ubaa8\ub4dc \ud14c\uc2a4\ud2b8 \ud328\ub110\uc758 \ube44\uc6a9 \ubc0f \uc18c\uc694 \uc2dc\uac04 \uc99d\uac00: \uc5ec\ub7ec \ud14c\uc2a4\ud2b8\ub97c \ub3d9\uc2dc\uc5d0 \uc9c4\ud589\ud558\ub294 \ub2e4\uc911 \ubaa8\ub4dc \ud14c\uc2a4\ud2b8 \ud328\ub110\uc758 \ube44\uc6a9 \uc0c1\uc2b9\uacfc \uae34 \uc18c\uc694 \uc2dc\uac04\uc740 \ubd80\ub2f4\uc73c\ub85c \uc791\uc6a9\ud569\ub2c8\ub2e4.<br \/>\n2.  \uc2e0\ud765 \uc9c0\uc5ed\uc758 ISO-17025 \uc900\uc218 \uc2e4\ud5d8\uc2e4 \uc5ed\ub7c9 \ubd80\uc871: \uc2e0\ud765 \uc9c0\uc5ed\uc5d0\uc11c\ub294 ISO-17025 \ud45c\uc900\uc744 \uc900\uc218\ud558\ub294 \uc2e4\ud5d8\uc2e4\uc758 \uc5ed\ub7c9\uc774 \ubd80\uc871\ud569\ub2c8\ub2e4.<br \/>\n3.  FDA\uc758 \ub370\uc774\ud130 \ubb34\uacb0\uc131 \uacbd\uace0: FDA\uc758 \ub370\uc774\ud130 \ubb34\uacb0\uc131 \uad00\ub828 \uacbd\uace0\ub294 \uace0\ube44\uc6a9\uc758 \uc7ac\ud14c\uc2a4\ud2b8\ub97c \uac15\uc81c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n4.  In-Silico \uc2dc\ubbac\ub808\uc774\uc158 \ub3c4\uc785: In-Silico \uc2dc\ubbac\ub808\uc774\uc158\uc758 \ub3c4\uc785\uc740 \uc77c\ubd80 \uc2b5\uc2dd \uc2e4\ud5d8\uc2e4(wet-lab) \uc218\uc775\uc744 \uac10\uc18c\uc2dc\ud0ac \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc138\ubd84\ud654 \ubd84\uc11d:<br \/>\n\ubcf4\uace0\uc11c\ub294 \uc11c\ube44\uc2a4 \uc720\ud615, \uac1c\ubc1c \ub2e8\uacc4, \uae30\uae30 \ub4f1\uae09, \ucd5c\uc885 \uc0ac\uc6a9\uc790 \ubc0f \uc9c0\uc5ed\ubcc4\ub85c \uc2dc\uc7a5\uc744 \uc138\ubd84\ud654\ud558\uc5ec \ubd84\uc11d\ud569\ub2c8\ub2e4.<br \/>\n*   \uc11c\ube44\uc2a4 \uc720\ud615\ubcc4: \uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8, \uba78\uade0 \ubc0f \ubbf8\uc0dd\ubb3c \ud14c\uc2a4\ud2b8, \uc7ac\ub8cc \ud2b9\uc131 \ubd84\uc11d \ubc0f \ubd84\uc11d \ud654\ud559, \uc804\uae30 \uc548\uc804 \ubc0f EMC \ud14c\uc2a4\ud2b8, \ud3ec\uc7a5 \ubc0f \uc720\ud6a8 \uae30\uac04 \ud14c\uc2a4\ud2b8, \uae30\ud0c0\ub85c \ub098\ub269\ub2c8\ub2e4. \uc774 \uc911 \uc804\uae30 \uc548\uc804 \ubc0f EMC \ud14c\uc2a4\ud2b8\ub294 \uc5f0\uacb0\ub41c \uae30\uae30\uc758 \ud655\uc0b0\uacfc IEC \uba74\uc5ed \ud45c\uc900 \uc5c5\ub370\uc774\ud2b8\uc5d0 \ud798\uc785\uc5b4 \uc5f0\ud3c9\uade0 13.44%\ub85c \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<br \/>\n*   \uac1c\ubc1c \ub2e8\uacc4\ubcc4: \uc804\uc784\uc0c1, \uc784\uc0c1, \uc2dc\ud310 \ud6c4\/PMS \ub2e8\uacc4\ub85c \uad6c\ubd84\ub429\ub2c8\ub2e4. EU-MDR \ubc0f \uc720\uc0ac \uaddc\uc815\uc73c\ub85c \uc778\ud574 \uc81c\ud488 \uc218\uba85 \uc8fc\uae30 \uc804\ubc18\uc5d0 \uac78\uccd0 \uc2e4\uc81c \uc131\ub2a5 \ub370\uc774\ud130\ub97c \uc218\uc9d1\ud574\uc57c \ud558\ubbc0\ub85c \uc2dc\ud310 \ud6c4 \uac10\uc2dc \ud14c\uc2a4\ud2b8\uc758 \uc911\uc694\uc131\uc774 \ucee4\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n*   \uae30\uae30 \ub4f1\uae09\ubcc4: Class I, Class II, Class III\ub85c \ubd84\ub958\ub429\ub2c8\ub2e4.<br \/>\n*   \ucd5c\uc885 \uc0ac\uc6a9\uc790\ubcc4: \uc758\ub8cc\uae30\uae30 OEM, \uacc4\uc57d \uc81c\uc870 \uc870\uc9c1(CMO), \uacc4\uc57d \uc5f0\uad6c \uc870\uc9c1(CRO), \uae30\ud0c0\ub85c \uad6c\uc131\ub429\ub2c8\ub2e4.<br \/>\n*   \uc9c0\uc5ed\ubcc4: \ubd81\ubbf8, \uc720\ub7fd, \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591, \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74, \ub0a8\ubbf8\ub85c \ub098\ub269\ub2c8\ub2e4. \uc774 \uc911 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc740 \uc81c\uc870 \uae30\ubc18 \ud655\uc7a5, \uaddc\uc81c \uc870\ud654 \ubc0f \uc758\ub8cc \ud22c\uc790 \uc99d\uac00\uc5d0 \ud798\uc785\uc5b4 \uc5f0\ud3c9\uade0 12.04%\ub85c \uac00\uc7a5 \ube60\ub978 \uc131\uc7a5\uc744 \ubcf4\uc77c \uac83\uc73c\ub85c \uc608\uce21\ub429\ub2c8\ub2e4.<\/p>\n<p>\uacbd\uc7c1 \ud658\uacbd:<br \/>\n\uacbd\uc7c1 \ud658\uacbd \uc139\uc158\uc5d0\uc11c\ub294 \uc2dc\uc7a5 \uc9d1\uc911\ub3c4, \uc2dc\uc7a5 \uc810\uc720\uc728 \ubd84\uc11d, \uadf8\ub9ac\uace0 Eurofins Scientific, SGS SA, Intertek Group plc, T\u00dcV S\u00dcD AG, WuXi AppTec, NAMSA, Nelson Labs, UL Solutions\/Emergo, Smithers, Element Materials Technology, Charles River Laboratories, T\u00dcV Rheinland, SGS-Brightsight, MCRA, Bureau Veritas, Tentamus Group, BSI Group, Labcorp, Veranex, Medistri \ub4f1 \uc8fc\uc694 \uae30\uc5c5\ub4e4\uc758 \ud504\ub85c\ud544\uc744 \uc0c1\uc138\ud788 \ub2e4\ub8f9\ub2c8\ub2e4. \uac01 \uae30\uc5c5\uc758 \uae00\ub85c\ubc8c \ubc0f \uc2dc\uc7a5 \uc218\uc900 \uac1c\uc694, \ud575\uc2ec \ubd80\ubb38, \uc7ac\ubb34 \uc815\ubcf4, \uc804\ub7b5 \uc815\ubcf4, \uc2dc\uc7a5 \uc21c\uc704\/\uc810\uc720\uc728, \uc81c\ud488 \ubc0f \uc11c\ube44\uc2a4, \ucd5c\uadfc \uac1c\ubc1c \uc0ac\ud56d \ub4f1\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc2dc\uc7a5 \uae30\ud68c \ubc0f \ubbf8\ub798 \uc804\ub9dd:<br \/>\n\ubcf4\uace0\uc11c\ub294 \ub610\ud55c \uc2dc\uc7a5\uc758 \ubbf8\uac1c\ucc99 \uc601\uc5ed(white-space)\uacfc \ucda9\uc871\ub418\uc9c0 \uc54a\uc740 \uc694\uad6c(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-59416","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\/59416"}],"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=59416"}],"version-history":[{"count":0,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts\/59416\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/media?parent=59416"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/categories?post=59416"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/tags?post=59416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}