{"id":2737,"date":"2024-01-18T09:49:16","date_gmt":"2024-01-18T00:49:16","guid":{"rendered":"https:\/\/alm.engineering\/?p=2737"},"modified":"2024-01-23T09:27:59","modified_gmt":"2024-01-23T00:27:59","slug":"2024%eb%85%84-%ec%9d%98%eb%a3%8c-%ea%b8%b0%ea%b8%b0-%eb%b0%8f-%ec%83%9d%eb%aa%85-%ea%b3%bc%ed%95%99-%ec%a0%9c%ed%92%88-%ec%8b%9c%ec%8a%a4%ed%85%9c-%ec%86%8c%ed%94%84%ed%8a%b8%ec%9b%a8%ec%96%b4","status":"publish","type":"post","link":"https:\/\/alm.engineering\/?p=2737","title":{"rendered":"2024\ub144 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \uc81c\ud488, \uc2dc\uc2a4\ud15c, \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c \uc608\uce21"},"content":{"rendered":"\n<p>\uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \uc0b0\uc5c5\uc774 2024\ub144\uc5d0 \uc811\uc5b4\ub4e4\uba74\uc11c \uc81c\ud488, \uc2dc\uc2a4\ud15c, \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c\uc758 \ubcc0\ud654\ub97c \uc8fc\ub3c4\ud558\ub294 \uc694\uc778\uc5d0 \ub300\ud55c \uc2ec\uce35\uc801\uc778 \uc778\uc0ac\uc774\ud2b8\ub97c \uc5bb\uace0, \uc774 \ubd84\uc57c\uc758 \ud300\ub4e4\uc774 \uc9c4\ud654\ud558\ub294 \ubcf5\uc7a1\uc131\uc73c\ub85c \uc778\ud574 \uc81c\uae30\ub418\ub294 \uacfc\uc81c\ub97c \ud574\uacb0\ud558\uae30 \uc704\ud574 \uc5b4\ub5bb\uac8c \uc801\uc751\ud558\uace0 \uc788\ub294\uc9c0 \uc0b4\ud3b4\ubcf4\uace0\uc790 \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ucd1d 6\ubd80\ub85c \uad6c\uc131\ub41c \uc774 \uc2dc\ub9ac\uc988\uc758 4\ubd80\uc5d0\uc11c\ub294 \ub2e4\uc74c\uacfc \uac19\uc740 \uc5c5\uacc4 \uc804\ubb38\uac00\ub4e4\uc5d0\uac8c \ub0b4\ub144\uc5d0 \uc608\uc0c1\ub418\ub294 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85\uacfc\ud559 \uc81c\ud488, \uc2dc\uc2a4\ud15c, \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud2b8\ub80c\ub4dc\uc5d0 \ub300\ud55c \uc758\uacac\uc744 \ubb3c\uc5c8\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Shawnnah Monterrey, MBA&nbsp;\u2013 CEO,&nbsp;BeanStock Ventures<\/li>\n\n\n\n<li>Vincent Balgos&nbsp;\u2013 \uc194\ub8e8\uc158 \ubc0f \ucee8\uc124\ud305 \ub2f4\ub2f9 \uc774\uc0ac,&nbsp;Jama Software<\/li>\n\n\n\n<li>Romer De Los Santos&nbsp;\u2013 \uc120\uc784 \uc194\ub8e8\uc158 \ucee8\uc124\ud134\ud2b8,&nbsp;Jama Software<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \ub514\uc790\uc778 \ud2b8\ub80c\ub4dc &#8211; \ud604\uc7ac \uc5c5\uacc4\uc5d0\uc11c \uac00\uc7a5 \ud070 \ud2b8\ub80c\ub4dc\ub294 \ubb34\uc5c7\uc778\uac00\uc694? \uc774\ub7ec\ud55c \ud2b8\ub80c\ub4dc\uac00 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \uac1c\ubc1c\uc5d0 \uc5b4\ub5a4 \uc601\ud5a5\uc744 \ubbf8\uce60\uae4c\uc694?<\/h2>\n\n\n\n<p><strong>Shawnnah Monterrey:<\/strong>&nbsp;\ud2b9\ud788 \uccb4\uc678 \uc9c4\ub2e8 \ubc0f \uc784\uc0c1 \uc758\uc0ac \uacb0\uc815 \uc9c0\uc6d0 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc640 \uac19\uc740 \uc758\ub8cc \ud601\uc2e0\uc774 \ud06c\uac8c \uc99d\uac00\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud074\ub77c\uc6b0\ub4dc \ucef4\ud4e8\ud305\uc758 \ub4f1\uc7a5, \ubc1c\uc804, \ub370\uc774\ud130 \uc800\uc7a5 \uc6a9\ub7c9\uc758 \uc99d\uac00\ub85c \uc758\ub8cc \uae30\uae30\ub97c \uc5f0\uacb0\ud558\uc5ec \uc758\ub8cc \uae30\uae30 \ub370\uc774\ud130\ub97c \uacf5\uc720\ud560 \uc218 \uc788\uac8c \ub418\uba74\uc11c \uc9c4\ub2e8 \ubc0f \uc784\uc0c1 \uc758\uc0ac \uacb0\uc815 \uc9c0\uc6d0 \ubd84\uc57c\uc5d0\uc11c \uc0c8\ub85c\uc6b4 \uc784\uc0c1 \uc778\uc0ac\uc774\ud2b8\ub97c \ub3c4\ucd9c\ud560 \uc218 \uc788\uac8c \ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc778\uacf5 \uc9c0\ub2a5(AI)\uacfc \uba38\uc2e0 \ub7ec\ub2dd(ML)\uc740 \uccb4\uc678 \uc218\uc815, \uc554 \uce58\ub8cc \uad8c\uc7a5 \uc0ac\ud56d, \ud604 \uc0c1\ud0dc\uc758 \uc218\uc791\uc5c5 \uc784\uc0c1 \ud504\ub85c\uc138\uc2a4 \uc790\ub3d9\ud654 \ub4f1 \ub3c5\ud2b9\ud558\uace0 \uc0c8\ub85c\uc6b4 \ubc29\uc2dd\uc73c\ub85c \uc784\uc0c1 \ubc0f \ud658\uc790 \ub370\uc774\ud130\uc5d0 \uc801\uc6a9\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc6b0\ub9ac \ubab8\uc758 DNA\uc640 \uac74\uac15\uacfc\uc758 \uad00\uacc4\ub97c \uc774\ud574\ud558\uae30 \uc704\ud55c \uc5f0\uad6c\uac00 \uc99d\uac00\ud568\uc5d0 \ub530\ub77c DNA \ub098\ub178\uae30\uc220 \ub3c4\uad6c, \uce69 \uae30\ubc18 \ub514\uc9c0\ud138 \uc911\ud569\ud6a8\uc18c\uc5f0\uc1c4\ubc18\uc751(PCR) \uac80\ucd9c, \ud06c\ub9ac\uc2a4\ud37c(CRISPR) \uc9c4\ub2e8 \uae30\uc220 \ub4f1 \ucc28\uc138\ub300 \uc5fc\uae30\uc11c\uc5f4 \ubd84\uc11d \ubc0f \uae30\ud0c0 DNA \uac80\ucd9c \uae30\uc220\uc744 \ud65c\uc6a9\ud55c DNA \uae30\ubc18 \uc784\uc0c1 \ub3c4\uad6c\uac00 \ube60\ub974\uac8c \ub3c4\uc785\ub418\uc5b4 \uc554, \uc2e0\uacbd \ud1f4\ud589\uc131 \uc9c8\ud658, \uce58\ub9e4, \uc2ec\uc9c0\uc5b4 \ud589\ub3d9 \ubc0f \uc815\uc2e0 \uc7a5\uc560\uc640 \uac19\uc740 \ubcf5\uc7a1\ud55c \uc9c8\ubcd1\uc758 \uc9c4\ub2e8\uacfc \uce58\ub8cc\uc5d0 \ub3c4\uc6c0\uc774 \ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong><strong>Vincent Balgos<\/strong>: <\/strong>\ub2e4\ub978 \uc5c5\uacc4\uc5d0\uc11c \ubcfc \uc218 \uc788\ub4ef\uc774 \uc758\ub8cc \uc5c5\uacc4\uc5d0\uc11c\ub3c4 \uc870\uc9c1\uc774 \ub0b4\ubd80 \ud504\ub85c\uc138\uc2a4\ub97c \uc0c8\ub86d\uac8c \uc815\ube44\ud558\uc5ec \ud655\uc7a5, \ud1b5\ud569, \ud6a8\uc728\uc131\uc744 \ub192\uc774\uace0 \uc788\ub294 \uac83\uc774 \uc77c\ubc18\uc801\uc778 \ucd94\uc138\uc785\ub2c8\ub2e4. \uc2dc\uc7a5, \uc7ac\ubb34 \ubc0f \uaddc\uc81c\uc640 \uac19\uc740 \uc678\uc801 \uc555\ub825\uc73c\ub85c \uc778\ud574 \ud2b9\ud788 \uc81c\ud488 \uac1c\ubc1c \ud504\ub85c\uc138\uc2a4\ub97c \uc911\uc2ec\uc73c\ub85c \uc870\uc9c1 \ud65c\ub3d9\uc744 \ucd5c\uc801\ud654\ud558\uace0 \uc774\uc804 \uc791\uc5c5\uc744 \ucd5c\ub300\ud55c \ud65c\uc6a9\ud558\ub824\ub294 \ub178\ub825\uc774 \uacc4\uc18d\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \uac00\uc7a5 \ud070 \ub3c4\uc804- 2024\ub144\uc5d0 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \uae30\uc5c5\uc774 \uadf9\ubcf5\ud574\uc57c \ud560 \uac00\uc7a5 \ud070 \ub3c4\uc804\uc740 \ubb34\uc5c7\uc774\ub77c\uace0 \uc0dd\uac01\ud558\uc2dc\ub098\uc694?<\/h2>\n\n\n\n<p><strong><strong>Monterrey<\/strong>:<\/strong>2024\ub144\uc5d0 \uae30\uc5c5\uc774 \uc9c1\uba74\ud558\uac8c \ub420 \uac00\uc7a5 \ud070 \uacfc\uc81c\uc5d0\ub294 \ub2e4\uc74c\uacfc \uac19\uc740 \uac83\ub4e4\uc774 \ud3ec\ud568\ub418\uc9c0\ub9cc \uc774\uc5d0 \uad6d\ud55c\ub418\uc9c0\ub294 \uc54a\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uaddc\uc81c\uac00 \uc2ec\ud55c \ud658\uacbd\uc5d0\uc11c \uacbd\uc7c1\ub825\uacfc \ud601\uc2e0 \uc720\uc9c0<\/li>\n\n\n\n<li>\uc2e0\uaddc \ub610\ub294 \ub35c \uc131\uc219\ud55c \uaddc\uc81c \uc601\uc5ed\uc758 \uaddc\uc81c \uc694\uac74 \uc774\ud574\ud558\uae30<\/li>\n\n\n\n<li>\uaddc\uc81c \ubc0f \uac1c\ubc1c \ub178\ub825\uc744 \uc9c0\uc6d0\ud558\uae30 \uc704\ud55c \uc790\uae08 \ud655\ubcf4<\/li>\n<\/ul>\n\n\n\n<p>\uc81c\ud488 \ub85c\ub4dc\ub9f5\uc744 \uac74\uc804\ud55c \uaddc\uc81c \uc804\ub7b5\uc5d0 \ub9de\ucd94\ub294 \ub370 \uc9d1\uc911\ud558\ub294 \uae30\uc5c5\uc740 \uc790\uae08\uc744 \ud655\ubcf4\ud560 \ubfd0\ub9cc \uc544\ub2c8\ub77c \ub354 \ube60\ub974\uac8c \uc218\uc775\uc744 \ucc3d\ucd9c\ud558\uc5ec \uacbd\uc7c1\uc5d0\uc11c \uc55e\uc11c \ub098\uac08 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \uaddc\uc815 &#8211; 2024\ub144\uc5d0 \uae30\uc5c5\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\ub294 \uaddc\uc81c \uc9c0\uce68\uc758 \ubcc0\ud654\uc5d0\ub294 \uc5b4\ub5a4 \uac83\uc774 \uc788\ub098\uc694?<\/h2>\n\n\n\n<p><strong><strong>Monterrey<\/strong><\/strong>: <a href=\"https:\/\/www.fda.gov\/\" data-type=\"link\" data-id=\"https:\/\/www.fda.gov\/\">\ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)<\/a>\uc740 \ube60\ub974\uc9c0\ub294 \uc54a\uc9c0\ub9cc \ucd5c\uadfc \uba87 \ub144 \ub3d9\uc548 \uae30\ub85d\uc801\uc778 \uc218\uc758 \uc9c0\uce68\uc744 \ubc1c\ud45c\ud588\uc73c\uba70 \uc77c\ubd80 \ubd84\uc57c\uc5d0\uc11c\ub294 \uc758\ub8cc \uae30\uae30 \uaddc\uc815\uc744 \ubcc0\uacbd\ud558\uae30\ub3c4 \ud588\uc2b5\ub2c8\ub2e4. \uc5c5\uacc4\ub294 \ub2e4\uc74c\uacfc \uac19\uc740 \ubd84\uc57c\uc5d0\uc11c \uc218\ubc31 \uac1c\uc758 \uc0c8\ub85c\uc6b4 \uc9c0\uce68\uc744 \ub530\ub77c\uc7a1\uace0 \uc788\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc758\ub8cc \uae30\uae30\uc6a9 \uc18c\ud504\ud2b8\uc6e8\uc5b4(SaMD)<\/li>\n\n\n\n<li>\uc0ac\uc774\ubc84 \ubcf4\uc548<\/li>\n\n\n\n<li>\uc784\uc0c1 \uc758\uc0ac \uacb0\uc815 \uc9c0\uc6d0 \uc18c\ud504\ud2b8\uc6e8\uc5b4<\/li>\n\n\n\n<li>\ubaa8\ubc14\uc77c \uc560\ud50c\ub9ac\ucf00\uc774\uc158<\/li>\n<\/ul>\n\n\n\n<p>FDA\ub294 <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/510k-third-party-review-program\" data-type=\"link\" data-id=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/510k-third-party-review-program\">510(k) \uc81c3\uc790 \uac80\ud1a0 \ud504\ub85c\uadf8\ub7a8<\/a>, \uccb4\uc678 \uc9c4\ub2e8(IVD), AI\/ML, \uc2dc\ud310 \uc804 \uc81c\ucd9c \uc2dc \uc2e4\uc81c \ub370\uc774\ud130 \ubc0f \uc2dc\ubbac\ub808\uc774\uc158 \ub370\uc774\ud130 \uc0ac\uc6a9 \ub4f1 \uc5ec\ub7ec \ubd84\uc57c\uc5d0 \ub300\ud55c \uaddc\uc815\uacfc \uc9c0\uce68\uc744 \uac1c\uc120\ud558\uae30 \uc704\ud574 \ub178\ub825\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uae30\uc5c5\uc740 \ucd5c\uc885 \ucd08\uc548\uc774 \ubc1c\ud45c\ub418\uae30 \uc804\uc5d0 \uc790\uc0ac \uc81c\ud488\uacfc \uad00\ub828\ub41c \uc0c8\ub85c\uc6b4 \uc9c0\uce68 \ucd08\uc548\uc744 \uc774\ud574\ud558\uace0 \uc801\uc6a9\ud558\ub294 \uac83\uc774 \ud604\uba85\ud560 \uac83\uc785\ub2c8\ub2e4. \ucd5c\uc885 \ubc84\uc804\uc774 \ubc1c\ud45c\ub418\uba74 \uc81c\ud488 \uac1c\ubc1c \ubc0f \ucd9c\uc2dc \uacc4\ud68d\uc5d0 \ud070 \ucc28\uc9c8\uc774 \uc0dd\uae38 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>Balgos:<\/strong>&nbsp;\uc5c5\uacc4\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\uac70\ub098 \uacc4\uc18d \uc601\ud5a5\uc744 \ubbf8\uce60 \uba87 \uac00\uc9c0 \uaddc\uc815\uc774 \uc788\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA\uc758 <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions\" target=\"_blank\" rel=\"noreferrer noopener\">\uc758\ub8cc\uae30\uae30 \uc0ac\uc774\ubc84 \ubcf4\uc548\uc5d0 \uad00\ud55c \ucd5c\uc885 \uc9c0\uce68<\/a> &#8211; \uc9c0\ub09c \ud574\uc5d0 \uc774\uc5b4 \uc18c\ud504\ud2b8\uc6e8\uc5b4(SW)\uc5d0 \ucd08\uc810\uc744 \ub9de\ucd98 \uc774 \uc0c8\ub85c\uc6b4 \ucd5c\uc885 \uc9c0\uce68\uc5d0\uc11c\ub294 \uc0c8\ub85c\uc6b4 \ubcf4\uc548 \uc694\uad6c \uc0ac\ud56d(\uc608: \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc790\uc7ac \uba85\uc138\uc11c(SBOM)), \ud65c\ub3d9 \ubc0f \uc608\uc0c1 \ubb38\uc11c\uc5d0 \ub300\ud55c \uc9c0\uc18d\uc801\uc778 \ub17c\uc758\uac00 \uc694\uad6c\ub429\ub2c8\ub2e4.<\/li>\n\n\n\n<li>FDA\uc758 \uc2e4\ud5d8\uc2e4 \uac1c\ubc1c \ud14c\uc2a4\ud2b8(LDT)\uc5d0 \ub300\ud55c <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-proposes-rule-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests\" target=\"_blank\" rel=\"noreferrer noopener\">\uc81c\uc548\ub41c \uaddc\uc815<\/a> &#8211; \uc774 \uc7a5\uae30\uc801\uc778 \uc8fc\uc81c\uc5d0 \ub300\ud55c \ucd5c\uadfc\uc758 \uc0ac\uac74\uc5d0\uc11c \uc2dc\ud589 \uc7ac\ub7c9(ED)\uc5d0\uc11c \ubcf4\ub2e4 \uba85\uc2dc\uc801\uc778 FDA\uc758 LDT \uac10\ub3c5\uc73c\ub85c \uc804\ud658\ud558\ub294 \uc774 \uc0c8\ub85c\uc6b4 \uaddc\uc815\uc740 \uc2e4\ud5d8\uc2e4 \uc0b0\uc5c5\uc5d0 \uc0c1\ub2f9\ud55c \uc601\ud5a5\uc744 \ubbf8\uce60 \uac83\uc785\ub2c8\ub2e4. \uc5c5\uacc4\uc758 \ud53c\ub4dc\ubc31\uc774 \ud65c\ubc1c\ud558\uace0 \ubcf5\uc7a1\ud558\uae30 \ub54c\ubb38\uc5d0 \uc774\uc804\uc758 <a href=\"https:\/\/resources.jamasoftware.com\/whitepaper\/your-guide-to-the-verifying-accurate-leading-edge-ivct-development-valid-act\" target=\"_blank\" rel=\"noreferrer noopener\">VALID Act<\/a>\uac00 \ubd80\ud65c\ud560\uc9c0, \uc544\ub2c8\uba74 \uc0c8\ub85c\uc6b4 \uc81c\uc548\ub41c \uaddc\uc815\uc774 \uadf8\ub300\ub85c \uc720\uc9c0\ub420\uc9c0 \uad00\uc2ec\uc774 \uc3e0\ub9b4 \uac83\uc73c\ub85c \ubcf4\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li>FDA\uac00 \uc81c\uc548\ud55c <a href=\"https:\/\/www.fda.gov\/medical-devices\/guidance-documents-medical-devices-and-radiation-emitting-products\/cdrh-proposed-guidances-fiscal-year-2024fy2024\" target=\"_blank\" rel=\"noreferrer noopener\">2024\ub144 \uc6b0\uc120\uc21c\uc704 \uac00\uc774\ub4dc\ub77c\uc778 \ubaa9\ub85d<\/a>\uc5d0 \ub530\ub77c \uc218\uba85 \uc8fc\uae30 \uad00\ub9ac, \uc0ac\uc804 \uc81c\ucd9c \ubc0f \ubcc0\uacbd \uad00\ub9ac \uace0\ub824 \uc0ac\ud56d\uc758 \ub9e5\ub77d\uc5d0\uc11c AI\/\uba38\uc2e0\ub7ec\ub2dd\uc5d0 \uad00\ud55c \ucd94\uac00 \uc815\ubcf4\uac00 \uc81c\uacf5\ub429\ub2c8\ub2e4.<\/li>\n\n\n\n<li>EU\uc5d0\uc11c\ub294 \uc758\ub8cc\uae30\uae30 \uaddc\uc815(MDR)\uacfc \uccb4\uc678\uc9c4\ub2e8\uae30\uae30 \uaddc\uc815(IVDR)\uc774 \ubaa8\ub450 \uc0c8\ub85c\uc6b4 \uaddc\uc815\uc73c\ub85c \uc804\ud658\ud558\ub294 \uae30\uc5c5\ub4e4\uc5d0\uac8c \uacc4\uc18d \uc601\ud5a5\uc744 \ubbf8\uce60 \uac83\uc785\ub2c8\ub2e4. MDR\uc758 \uc2dc\ud589 \uc2dc\ud55c\uc774 \uc5f0\uc7a5\ub418\uc5c8\uc74c\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0, \uae30\uc5c5\ub4e4\uc740 2024\ub144 \uc2dc\ud589\uc744 \uc55e\ub450\uace0 \uc0c8\ub85c\uc6b4 \uaddc\uc815\uc744 \uc900\uc218\ud558\uae30 \uc704\ud574 \ud504\ub85c\uc138\uc2a4\ub97c \uc804\ud658\ud558\ub294 \ub370 \uc5b4\ub824\uc6c0\uc744 \uacaa\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p><strong><strong>Romer De Los Santos<\/strong> :<\/strong>&nbsp;FDA\ub294 \uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uac00 \uc774\ud589\ud574\uc57c \ud558\ub294 \ucd94\uac00 \uc791\uc5c5\uacfc \uacb0\uacfc\ubb3c\uc774 \ud3ec\ud568\ub41c \uc758\ub8cc <a href=\"https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/cybersecurity\" data-type=\"link\" data-id=\"https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/cybersecurity\">\uae30\uae30\uc758 \uc0ac\uc774\ubc84 \ubcf4\uc548\uc5d0 \uad00\ud55c \ucd5c\uc885 \uc9c0\uce68\uc744 \ubc1c\ud45c\ud588\uc2b5\ub2c8\ub2e4<\/a>. \uc758\ub8cc\uae30\uae30\uc758 \uc77c\ubd80\uc774\uac70\ub098 \uc758\ub8cc\uae30\uae30 \uc790\uccb4\uc778 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc124\uacc4 \ubc0f \uac1c\ubc1c \uc808\ucc28\ub294 \uc774 \uc0c8\ub85c\uc6b4 \uc9c0\uce68\uc744 \uc5fc\ub450\uc5d0 \ub450\uace0 \uc5c5\ub370\uc774\ud2b8\ud574\uc57c \ud569\ub2c8\ub2e4. \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc790\uc7ac \uba85\uc138\uc11c(SOBM), \ubcf4\uc548 \uc704\ud5d8 \ud3c9\uac00, \uc704\ud611 \ubaa8\ub378\ub9c1, \ubcf4\uc548 \uc704\ud5d8 \ubc0f \uc644\ud654\ub97c \uc704\ud55c \uc804\uccb4 \uc218\uba85 \uc8fc\uae30 \uace0\ub824\ub294 \uc624\ub298\ub0a0\uc758 \uc0c1\ud638 \uc5f0\uacb0\ub41c \uc138\uc0c1\uc5d0\uc11c \uc694\uad6c\ub418\ub294 \uc0ac\ud56d \uc911 \uc77c\ubd80\uc5d0 \ubd88\uacfc\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \ub3c4\uad6c \ud601\uc2e0 &#8211; \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \ub3c4\uad6c \uc138\ud2b8\uc758 \uad00\uc810\uc5d0\uc11c \ubcfc \ub54c, \ubbf8\ub798 \uc9c0\ud5a5\uc801\uc778 \uae30\uc5c5\uc774 \ud65c\uc6a9\ud558\uac70\ub098 \ud504\ub85c\uc138\uc2a4\uc5d0 \ud1b5\ud569\ud558\uae30 \uc704\ud574 \ub178\ub825\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\ub294 \ud504\ub85c\uc138\uc2a4\uc5d0\ub294 \uc5b4\ub5a4 \uac83\uc774 \uc788\uc73c\uba70 \uadf8 \uc774\uc720\ub294 \ubb34\uc5c7\uc778\uac00\uc694?<\/h2>\n\n\n\n<p><strong><strong>Monterrey<\/strong>:<\/strong>&nbsp;\uc81c\ud488 \uac1c\ubc1c \ube44\uc6a9, \uaddc\uc81c \ubcf5\uc7a1\uc131, \uc2dc\uc7a5 \ucd9c\uc2dc \uae30\uac04\uc740 \uc758\ub8cc\uae30\uae30 \uc5c5\uacc4\uc5d0\uc11c \uc810\uc810 \ub354 \ud070 \ud654\ub450\ub85c \ub5a0\uc624\ub974\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ud2b8\ub80c\ub4dc\uc5d0 \uc55e\uc11c \uc0dd\uac01\ud558\ub294 \uae30\uc5c5\ub4e4\uc740 \ud601\uc2e0 \ub610\ub294 \ud575\uc2ec \uc9c0\uc801 \uc7ac\uc0b0(IP)\uc744 \ud3ec\ud568\ud55c \uacbd\uc7c1 \uc6b0\uc704\uc5d0 \uc9d1\uc911\ud558\uace0 \uc5c5\uacc4 \uc804\ubb38\uac00\uc758 \uc9c0\uc6d0\uacfc \uc804\uc6a9 \ub3c4\uad6c\ub97c \ud65c\uc6a9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc18c\ud504\ud2b8\uc6e8\uc5b4, \uae30\ubcf8 \uc81c\uacf5 \ud504\ub85c\uc138\uc2a4, \uad50\uc721 \ub4f1 \uae30\uc874 \uaddc\uc81c \ubc0f \ud488\uc9c8 \uad00\ub9ac \ud504\ub808\uc784\uc6cc\ud06c\uc5d0 \ud22c\uc790<\/li>\n\n\n\n<li>\uaddc\uc81c \ud658\uacbd\uc744 \uc774\ud574\ud558\uace0 \uc81c\ud488\uacfc \uad00\ub828\ub41c \ub3c4\uba54\uc778 \uc804\ubb38 \uc9c0\uc2dd\uc744 \uac16\ucd98 \uaddc\uc81c \ubc0f \ud488\uc9c8 \uc804\ubb38\uac00\ub97c \ucc44\uc6a9<\/li>\n\n\n\n<li>\uc758\ub8cc\/\uc784\uc0c1 \ub4f1\uae09 \ub610\ub294 \ubd88\ub9cc \uc0ac\ud56d \ud50c\ub7ab\ud3fc \uc18c\ud504\ud2b8\uc6e8\uc5b4, \uad6c\uc131 \uc694\uc18c \ubc0f \uac1c\ubc1c \ub3c4\uad6c \ud1b5\ud569<\/li>\n<\/ul>\n\n\n\n<p><strong><strong><strong>De Los Santos<\/strong><\/strong> :<\/strong>&nbsp;\uae30\uc5c5\uc740 Jama Connect\uc640 \uac19\uc740 \ub3c4\uad6c\ub97c \ud65c\uc6a9\ud558\uc5ec \ubcf4\uc548 \uc704\ud5d8, SBOM, \uc218\ub9ce\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ubcc0\ud615, \uc5c5\uadf8\ub808\uc774\ub4dc \ubc0f \ud328\uce58\uc5d0 \ub300\ud55c \ubb38\uc11c\ub97c \ucd94\uc801\ud558\uae30 \uc2dc\uc791\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ub3c4\uad6c\ub97c \ud1b5\ud574 \uaddc\uc81c \uc694\uac74\uc744 \uc900\uc218\ud560 \uc218 \uc788\uc9c0\ub9cc, \uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\ub294 \ub3c4\uad6c\uc758 \uae30\ub2a5\uc744 \ud65c\uc6a9\ud558\ub294 \uacac\uace0\ud558\uace0 \uac00\ubcbc\uc6b4 \uc124\uacc4 \ubc0f \uac1c\ubc1c \ud504\ub85c\uc138\uc2a4\ub97c \uad6c\ucd95\ud574\uc57c \ud569\ub2c8\ub2e4. \ub9ce\uc740 \uae30\uc5c5\uc5d0\uc11c \uc774\ub294 \ud604\uc7ac\uc758 \uaddc\uc81c \uc694\uac74\uc744 \ucda9\uc871\ud558\uae30 \uc704\ud574 \uc808\ucc28\ub97c \ube60\ub974\uac8c \uc218\uc815\ud558\ub294 \ub300\uc2e0 \uc804\uccb4 \uac1c\ubc1c \uc218\uba85 \uc8fc\uae30\ub97c \uc804\uccb4\uc801\uc73c\ub85c \uc0b4\ud3b4\ubd10\uc57c \ud55c\ub2e4\ub294 \uac83\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \ub0b4\ub144\uacfc \uadf8 \uc774\ud6c4\uc5d0 \uc0ac\uc774\ubc84 \ubcf4\uc548\uc774 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \uac1c\ubc1c\uc5d0\uc11c \uc5b4\ub5a4 \uc5ed\ud560\uc744 \ud558\uac8c \ub420\uae4c\uc694?<\/h2>\n\n\n\n<p><strong><strong><strong>Monterrey<\/strong><\/strong>:<\/strong>\ud604\uc7ac FDA \uc9c0\uce68\uc5d0 \ub530\ub974\uba74 \ud38c\uc6e8\uc5b4 \ub610\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uac00 \uc5f0\uacb0\ub41c \uc758\ub8cc \uae30\uae30, \uc5f0\uacb0\ub41c \uc0c1\ud0dc \ub610\ub294 \uc5f0\uacb0\ub418\uc9c0 \uc54a\uc740 \uc0c1\ud0dc \ubaa8\ub450 \uc77c\uc815 \uc218\uc900\uc758 \uc0ac\uc774\ubc84 \ubcf4\uc548 \uaddc\uc815 \uc900\uc218, \ud2b9\ud788 \uc704\ud5d8 \uad00\ub9ac\uc640 \uad00\ub828\ud558\uc5ec \uc2dc\uc7a5\ubcc4 \uc2b9\uc778\/\ud5c8\uac00\ub97c \ud68d\ub4dd\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \uc9c0\uce68\uc740 \ub9e4\uc6b0 \uae30\uc220\uc801\uc774\uace0 \uc5c4\uaca9\ud558\uba70 \ud604\uc7ac \uae30\uae30\uc758 \uc704\ud5d8\ub3c4\uc5d0 \ub530\ub978 \uc801\uc6a9 \uc218\uc900\uc5d0 \ub300\ud55c \uc9c0\uce68\uc744 \uc81c\uacf5\ud558\uc9c0 \uc54a\uae30 \ub54c\ubb38\uc5d0 \uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc5d0 \ucd94\uac00\uc801\uc778 \ubd80\ub2f4\uc744 \uc8fc\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud5a5\ud6c4 \uc704\ud5d8\ub3c4\uac00 \ub0ae\uc740 \ub514\ubc14\uc774\uc2a4\ub97c \uc218\uc6a9\ud560 \uc218 \uc788\ub294 \uac1c\uc815\uc548\uc774 \ub098\uc624\uae30\ub97c \ubc14\ub77c\uc9c0\ub9cc, \uc9c0\uae08\uc740 \ub514\ubc14\uc774\uc2a4 \ubc0f \uad00\ub828 \ud504\ub85c\uc138\uc2a4\ub97c \uc778\uc99d\ud558\ub294 \ub370 \ub3c4\uc6c0\uc744 \uc904 \uc218 \uc788\ub294 \uc0ac\uc774\ubc84 \ubcf4\uc548 \uc804\ubb38\uac00\uc5d0\uac8c \ud22c\uc790\ud558\ub294 \uac83\uc774 \uc88b\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>Balgos:<\/strong>&nbsp;<a href=\"https:\/\/www.fda.gov\/medical-devices\/workshops-conferences-medical-devices\/webinar-final-guidance-cybersecurity-medical-devices-quality-system-considerations-and-content\" target=\"_blank\" rel=\"noreferrer noopener\">\ucd5c\uadfc FDA \uc6e8\ube44\ub098<\/a>\uc5d0\uc11c \uc5b8\uae09\ud588\ub4ef\uc774 \uc0ac\uc774\ubc84 \ubcf4\uc548\uacfc \uad00\ub828\ud558\uc5ec \uc774 \uc8fc\uc81c\ub97c \uaddc\uc81c\ud558\ub294 \ubc29\ubc95\uacfc \uae30\uad00\uc5d0 \uc81c\uacf5\ud560 \uc608\uc0c1 \uacb0\uacfc\ubb3c\uc5d0 \ub300\ud55c \ub17c\uc758\uac00 \uacc4\uc18d\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uadf8 \uc911 \ud55c \ubd84\uc57c\ub294 \uc758\ub8cc \uae30\uae30\uc6a9 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \ubaa8\ub4e0 \uc694\uc18c\ub97c \uc62c\ubc14\ub974\uac8c \ubb38\uc11c\ud654\ud558\ub294 \ubc29\ubc95\uacfc SBOM\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong><strong>De Los Santos<\/strong> :<\/strong>\uc81c\uc870\uc5c5\uccb4\uac00 \uc0ac\uc774\ubc84 \ubcf4\uc548\uc744 \ud3ec\ud568\ud558\ub3c4\ub85d \uc124\uacc4 \ubc0f \uac1c\ubc1c \ud504\ub85c\uc138\uc2a4\ub97c \uc218\uc815\ud558\uae30 \uc2dc\uc791\ud558\uba74\uc11c \uc0ac\uc774\ubc84 \ubcf4\uc548\uc774 \uc8fc\uc5f0 \uc5ed\ud560\uc744 \ud558\uac8c \ub420 \uac83\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: 2030\ub144\uae4c\uc9c0 \uc0b4\uc544\ub0a8\uc744 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \uae30\uc5c5\uacfc \uadf8\ub807\uc9c0 \ubabb\ud55c \uae30\uc5c5\uc758 \uac00\uc7a5 \ud070 \ucc28\uc774\uc810\uc740 \ubb34\uc5c7\uc774\ub77c\uace0 \uc0dd\uac01\ud558\uc2dc\ub098\uc694?<\/h2>\n\n\n\n<p><strong><strong><strong><strong>Monterrey<\/strong><\/strong><\/strong>:<\/strong>&nbsp;2030\ub144\uae4c\uc9c0 \uc0b4\uc544\ub0a8\ub294 \uc0ac\ub78c\ub4e4\uc740 \ud53c\ud560 \uc218 \uc5c6\ub294 \ubcc0\ud654\ub97c \uc9c0\uc5f0\uc2dc\ud0a4\uac70\ub098 \uc800\ud56d\ud558\uac70\ub098 \ud68c\ud53c\ud558\ub824\ub294 \uc0ac\ub78c\ub4e4 \ub300\uc2e0 \uaddc\uc81c \ud658\uacbd\uc744 \uc874\uc911\ud558\uace0 \uc801\uc808\ud55c \uad00\uc2ec\uacfc \ud22c\uc790\ub97c \ud560 \uac83\uc785\ub2c8\ub2e4. \uadf8\ub807\uac8c \ub290\uaef4\uc9c0\uc9c0 \uc54a\uc744 \uc218\ub3c4 \uc788\uc9c0\ub9cc, \ud604\uc7ac \uc2dc\ud589\ub418\uace0 \uc788\ub294 \ubcc0\ud654\ub294 \uc5c5\uacc4\uc5d0 \uc0c8\ub85c\uc6b4 \ud601\uc2e0\uc744 \uc704\ud55c \ubcf4\ub2e4 \uba85\ud655\ud55c \uacbd\ub85c\ub97c \uc81c\uacf5\ud558\ub824\ub294 \uc758\ub3c4\ub85c \uc6b0\ub9ac\uc5d0\uac8c \uc774\uc775\uc774 \ub418\ub294 \uac83\uc785\ub2c8\ub2e4. \uaddc\uc815\uc774 \uc870\ud654\ub97c \uc774\ub8e8\uace0 \uc5c5\uacc4\uac00 \ub370\uc774\ud130, \ub3c4\uad6c, \uc804\ubb38 \uc9c0\uc2dd\uc744 \ud65c\uc6a9\ud558\uc5ec \ube60\ub974\uac8c \ud601\uc2e0\ud568\uc73c\ub85c\uc368 \uc0c8\ub85c\uc6b4 \uc0ac\uace0\ubc29\uc2dd\uc5d0 \uc801\uc751\ud558\ub294 \ub370\ub294 \ub2e4\uc18c \uc2dc\uac04\uc774 \uac78\ub9b4 \uac83\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong><strong>De Los Santos<\/strong>:<\/strong>&nbsp;\uc81c\ud488\ubfd0\ub9cc \uc544\ub2c8\ub77c \ub514\uc790\uc778 \ubc0f \uac1c\ubc1c \ud504\ub85c\uc138\uc2a4\uc5d0 \uc788\uc5b4\uc11c\ub3c4 \uc801\uc751\ub825\uacfc \ud601\uc2e0\uc131\uc744 \uac16\ucd98 \uae30\uc5c5\uc740 2030\ub144\uae4c\uc9c0 \uc0b4\uc544\ub0a8\uc744 \uac83\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \uc758\ub8cc\uae30\uae30 \ubc0f \uc0dd\uba85\uacfc\ud559 \uc0b0\uc5c5\uc5d0 \uc0c8\ub86d\uac8c \uc9c4\ucd9c\ud558\ub294 \uae30\uc5c5\ub4e4\uc5d0\uac8c \uc5b4\ub5a4 \uc870\uc5b8\uc744 \ud574\uc8fc\uace0 \uc2f6\uc73c\uc2e0\uac00\uc694?<\/h2>\n\n\n\n<p><strong>Monterrey<\/strong>: \uc5c5\uacc4\ub97c \uc704\ud55c \uc81c\ud488 \uac1c\ubc1c &#8211; \uc81c\ud488 \uac1c\ubc1c \ub178\ub825\uc744 \ube44\uc988\ub2c8\uc2a4 \ubaa8\ub378 \ubc0f \uaddc\uc81c \uc804\ub7b5\uc5d0 \ub9de\ucd94\uace0, \uc774\uc804\uc5d0 \uc131\uacf5\uc801\uc73c\ub85c \uc218\ud589\ud55c \uacbd\ud5d8\uc774 \uc5c6\ub2e4\uba74 \uc5c5\uacc4 \uc804\ubb38\uac00\uc758 \uc9c0\uc6d0 \uc5c6\uc774 \uae30\uae30\uc5d0 \ub300\ud55c \uc2dc\ud310 \uc804 \uc2b9\uc778\uc744 \ubc1b\uc73c\ub824\uace0 \ud558\uc9c0 \ub9c8\uc138\uc694.<\/p>\n\n\n\n<p><strong>De Los Santos<\/strong>: \ub2e8\uc21c\ud568\uc744 \uc720\uc9c0\ud558\uc138\uc694.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \uae30\uc5c5\ub4e4\uc774 \ub354 \ub9ce\uc740 \uad00\uc2ec\uc744 \uae30\uc6b8\uc600\uc73c\uba74 \ud558\ub294 \uc8fc\uc81c\ub294 \ubb34\uc5c7\uc778\uac00\uc694?<\/h2>\n\n\n\n<p><strong>Monterrey<\/strong>: \ub354 \ub9ce\uc740 \uae30\uc5c5\uc774 \uac1c\ubc1c \uc218\uba85 \uc8fc\uae30 \ucd08\uae30\uc5d0 \uaddc\uc81c \uc804\ub7b5\uc744 \uc815\uc758\ud558\ub294 \ub370 \uc9d1\uc911\ud558\uace0, 6\uac1c\uc6d4 \uc774\ub0b4\uc5d0 \ub514\ubc14\uc774\uc2a4 \uc2b9\uc778 \ub610\ub294 \ud5c8\uac00\ub97c \ubc1b\uae30 \uc704\ud574 \uace0\ubbfc\ud558\uc9c0 \uc54a\uc558\uc73c\uba74 \uc88b\uaca0\uc2b5\ub2c8\ub2e4. \ub514\ubc14\uc774\uc2a4\uc758 \ubcf5\uc7a1\uc131\uc5d0 \ub530\ub77c \uaddc\uc81c \uc900\uc218 \ub178\ub825\uc5d0 12~36\uac1c\uc6d4\uc774 \uc18c\uc694\ub420 \uc218 \uc788\uc73c\uba70, \ub300\ubd80\ubd84\uc758 \ub178\ub825\uc740 \uac80\uc99d\uacfc \uc720\ud6a8\uc131 \uac80\uc0ac\uc5d0 \uc9d1\uc911\ub429\ub2c8\ub2e4. 6\uac1c\uc6d4 \uc804\uc5d0\ub294 \ub108\ubb34 \ub2a6\uc5b4 \ube44\uc988\ub2c8\uc2a4 \ucd9c\uc2dc \uacc4\ud68d\uc5d0 \ucc28\uc9c8\uc774 \uc0dd\uaca8 \uc774\ud574\uad00\uacc4\uc790\uc758 \uae30\ub300\uc5d0 \ubd80\uc751\ud558\uc9c0 \ubabb\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>De Los Santos<\/strong>: \uc800\ub294 \uae30\uc5c5\ub4e4\uc774 \ud328\uce58\ub97c \uc801\uc6a9\ud558\ub294 \ub300\uc2e0 \ud504\ub85c\uc138\uc2a4 \ubb38\uc81c\ub97c \ud574\uacb0\ud558\ub294 \ub370 \uc9d1\uc911\ud588\uc73c\uba74 \uc88b\uaca0\uc2b5\ub2c8\ub2e4. \ud504\ub7f0\ud2b8\uc5d4\ub4dc \uc791\uc5c5\uc744 \uc870\uae08\ub9cc \ub354 \ud558\uba74 \ud5a5\ud6c4 \ud300\uc5d0\uc11c \ub9ce\uc740 \uc2dc\uac04\uc744 \uc808\uc57d\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \ud604\uc7ac \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \ubd84\uc57c\uc5d0\uc11c \uae30\uc5c5\ub4e4\uc774 \uc800\uc9c0\ub974\uace0 \uc788\ub294 \uac00\uc7a5 \ud070 \uc2e4\uc218\ub294 \ubb34\uc5c7\uc778\uac00\uc694?<\/h2>\n\n\n\n<p><strong>Monterrey<\/strong>: \uc81c\uac00 \ubcf4\ub294 \uac00\uc7a5 \ud070 \uc2e4\uc218\ub294 \ub450 \uac00\uc9c0\uc785\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc758\ub8cc \uae30\uae30\uc784\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0 \uc758\ub8cc \uae30\uae30\uac00 \uc544\ub2cc \uac83\uc744 \uc758\ub8cc \uae30\uae30\ub85c \ub9cc\ub4e4\ub824\uace0 \ud558\ub294 \uac83<\/li>\n\n\n\n<li>\ucc98\uc74c \ucd9c\uc2dc\ud560 \ub54c \uc81c\ud488\uc758 \uc6a9\ub3c4\ub97c \uc881\ud788\uc9c0 \uc54a\ub294 \uac83<\/li>\n<\/ul>\n\n\n\n<p><br><strong>Balgos<\/strong>: \ub2e8\uae30\uc801\uc778 \uc774\uc775\uc744 \uc704\ud574 \ube44\uc6a9\uc744 \uc808\uac10\ud558\uc9c0\ub9cc, \uc2e4\uc81c\ub85c\ub294 \uc774\ub7ec\ud55c \ube44\uc6a9 \uc808\uac10\uc740 \uc7a5\uae30\uc801\uc73c\ub85c \uae30\ud558\uae09\uc218\uc801\uc778 \uacb0\uacfc\ub97c \ucd08\ub798\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc608\uc2dc: \ubb38\uc11c\ud654. \uae30\uc220 \uace0\uac1d\ub4e4\uc740 (\uadf8\ub9ac\uace0 \uc81c \uac1c\uc778\uc801\uc778 \uacbd\ud5d8\uc5d0 \ube44\ucd94\uc5b4 \ubcfc \ub54c) \uc81c\ud488\uc744 \uba3c\uc800 \ucd9c\uc2dc\ud558\uace0 \ubb38\uc11c\ud654\ub294 \ub098\uc911\uc5d0 \ud558\ub77c\ub294 \uc555\ubc15\uc744 \uacc4\uc18d \ubc1b\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \uba87 \uac00\uc9c0 \ubb38\uc81c\uac00 \uc788\uc2b5\ub2c8\ub2e4: <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc2dc\uc7a5 \ud5c8\uac00\ub97c \uc704\ud55c \uaddc\uc81c \uc81c\ucd9c\uc744 \uc704\ud574 \uae30\uc220 \ubb38\uc11c\uc640 \ud30c\uc77c\uc774 \ud544\uc694\ud558\uace0, <\/li>\n\n\n\n<li>\uac80\ud1a0\/\uc2b9\uc778\uc5d0 \uc2dc\uac04\uc774 \ud544\uc694\ud558\uae30 \ub54c\ubb38\uc5d0 \uc77c\ubc18\uc801\uc73c\ub85c \ub300\ubd80\ubd84\uc758 \ubaa8\ubc94 \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \ubc0f \ud488\uc9c8 \uad00\ud589\uacfc \uc0c1\ucda9\ub418\uba70, <\/li>\n\n\n\n<li>\ubb38\uc81c\uac00 \ubc1c\uc0dd\ud55c \uc9c0 \ud55c\ucc38 \uc9c0\ub09c \ud6c4\uc5d0 \ubb38\uc11c\ud654\ud558\ub294 \uac83\uc774 \ud6e8\uc52c \uc5b4\ub835\ub2e4\ub294 \uc810\uc785\ub2c8\ub2e4. <\/li>\n<\/ul>\n\n\n\n<p>\uc774\ub7ec\ud55c \ubb38\uc81c\ub85c \uc778\ud574 \ubb38\uc11c\ub97c \uc644\uc131\ud558\ub294 \ub370 \ud6e8\uc52c \ub354 \uc624\ub79c \uc2dc\uac04\uc774 \uac78\ub9ac\uace0, \uc7a5\uae30\uc801\uc73c\ub85c\ub3c4 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>De Los Santos<\/strong>: \uae30\uc5c5\uc740 \uc808\ucc28\ub97c \ud544\uc694 \uc774\uc0c1\uc73c\ub85c \ubcf5\uc7a1\ud558\uac8c \ub9cc\ub4e4\uc5b4\uc11c\ub294 \uc548 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \uc62c\ud574 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \ubd84\uc57c\uc5d0\uc11c \uac00\uc7a5 \ud601\uc2e0\uc801\uc774\uc5c8\uace0, \uc55e\uc73c\ub85c \ub2e4\ub978 \ud68c\uc0ac\ub4e4\ub3c4 \uc774\ub97c \ub530\ub77c\uac08 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\ub294 \uac83\uc740 \ubb34\uc5c7\uc778\uac00\uc694?<\/h2>\n\n\n\n<p><strong>Monterrey<\/strong>: \uc81c\uac00 \ubcf8 \uac83 \uc911 \uac00\uc7a5 \ud601\uc2e0\uc801\uc778 \uac83\uc740 \uc2dc\ud310 \uc804 \uc2b9\uc778\uc744 \uc9c0\uc6d0\ud558\uae30 \uc704\ud574 \uc2dc\ubbac\ub808\uc774\uc158 \ubc0f \uc2e4\uc81c \ub370\uc774\ud130\ub97c \ucc3d\uc758\uc801\uc73c\ub85c \uc0ac\uc6a9\ud558\uace0, \uc11c\ub85c \uad00\ub828\uc774 \uc5c6\ub294 \uc5ec\ub7ec \uae30\uae30\uc758 \ub370\uc774\ud130\ub97c \uc0ac\uc6a9\ud558\uc5ec \ub2e4\uc591\ud55c \uc9c8\ubcd1\uacfc \uc758\ud559\uc801 \uc0c1\ud0dc\ub97c \uc9c4\ub2e8, \uce58\ub8cc \ub610\ub294 \uc9c0\uc6d0\ud558\ub294 \uc0c8\ub85c\uc6b4 AI \uc751\uc6a9 \ud504\ub85c\uadf8\ub7a8\uc785\ub2c8\ub2e4. \ub2e4\uc591\ud55c \uc6a9\ub3c4\uc758 \uae30\uc220 \ud50c\ub7ab\ud3fc\uc744 \uc81c\uacf5\ud558\ub294 \uc81c\ud488\uc774 \uc810\uc810 \ub354 \ub9ce\uc544\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc131\uacf5\ud558\ub294 \uae30\uc5c5\ub4e4\uc740 \uae34 \uc548\ubaa9\uc744 \uac00\uc9c0\uace0 \uac00\uc7a5 \ucd9c\uc2dc\ud558\uae30 \uc26c\uc6b4 \uc6a9\ub3c4\uc5d0 \uba3c\uc800 \uc9d1\uc911\ud558\uc5ec \uc218\uc775\uc744 \ucc3d\ucd9c\ud55c \ub2e4\uc74c, \ubcf4\ub2e4 \uc5c4\uaca9\ud55c \uaddc\uc81c \uacbd\ub85c\uac00 \ud544\uc694\ud55c \ud601\uc2e0\uc744 \ud3ec\ud568\ud55c \ucd94\uac00 \uc81c\ud488 \uc801\uc6a9\uc5d0 \uc9d1\uc911\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \uc608\uce21 &#8211; 2024\ub144\uae4c\uc9c0 \uadc0\uc0ac\uc758 \uc5c5\uacc4\uc5d0\uc11c \ubb34\uc5c7\uc774 \ubcc0\ud558\uc9c0 \uc54a\uc744 \uac83\uc774\ub77c\uace0 \uc0dd\uac01\ud558\uc2dc\ub098\uc694?<\/h2>\n\n\n\n<p><strong><strong>Monterrey<\/strong>: <\/strong>2024\ub144\uc740 \ub9e4\uc6b0 \ud601\uc2e0\uc801\uc778 \ud55c \ud574\uac00 \ub420 \uac83\uc774\uba70, \uc55e\uc73c\ub85c \ub354 \ub9ce\uc740 \ubcc0\ud654\uac00 \uc788\uc744 \uac83\uc774\uace0, \uc0c8\ub86d\uace0 \ucc38\uc2e0\ud55c \uc784\uc0c1 \ud601\uc2e0\uc774 \uacc4\uc18d\ud574\uc11c \uc5c5\uacc4\ub97c \ub4a4\ud754\ub4e4 \uac83\uc785\ub2c8\ub2e4. 2024\ub144\uc740 \ud765\ubbf8\uc9c4\uc9c4\ud558\uace0 \uc804\ub840 \uc5c6\ub294 \ud55c \ud574\uac00 \ub420 \uac83\uc785\ub2c8\ub2e4!<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: \ub0b4\ub144\uc5d0 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \ubd84\uc57c\uc5d0 \ud070 \ubcc0\ud601\uc774 \uc77c\uc5b4\ub0a0 \uac83\uc774\ub77c\uace0 \uc0dd\uac01\ud558\uc2dc\ub098\uc694? \uc5c5\uacc4\uc5d0 \uc5b4\ub5a4 \uc601\ud5a5\uc744 \ubbf8\uce60 \uac83\uc774\ub77c\uace0 \uc0dd\uac01\ud558\uc2dc\ub098\uc694?<\/h2>\n\n\n\n<p><strong>Monterrey<\/strong>: \uc8fc\uc694 \ud30c\uad34\uc801 \ud601\uc2e0\uc740 \uc774\uc804\uc5d0\ub294 \ubb34\uc2dc\ub418\uac70\ub098 \ubc29\uce58\ub418\uc5c8\ub358 \uc9c8\ubcd1\uacfc \uc0c1\ud0dc\uc5d0 \ucd08\uc810\uc744 \ub9de\ucd98 \uac83\uc5d0\uc11c \ube44\ub86f\ub420 \uac83\uc785\ub2c8\ub2e4. \uc81c\uac00 \uae30\ub300\ud558\ub294 \ud55c \uac00\uc9c0 \ubd84\uc57c\ub294 \ucc98\ubc29\uc57d, \uae30\uae30, \uc218\uc220\uc774 \uc544\ub2cc \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \uce58\ub8cc\uc81c\ub85c \uc0ac\uc6a9\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \ud658\uae09\uc5d0 \ub300\ud55c \uc81c\ud55c\uacfc \uce58\ub8cc \uae30\uae30\ub85c\uc11c\uc758 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \ube44\uc804\ud1b5\uc801 \uc0ac\uc6a9\uc73c\ub85c \uc778\ud574 \uc774 \ubd84\uc57c\ub294 \ucc44\ud0dd\uc774 \uc9c0\uc5f0\ub418\ub294 \uc5b4\ub824\uc6c0\uc744 \uacaa\uc5b4 \uc654\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>Balgos<\/strong>: AI\/ML\uc758 \ub4f1\uc7a5\uc740 \uc801\uc6a9 \ubd84\uc57c\ub098 \uc0ac\uc6a9 \ubaa9\uc801\uc5d0 \ub530\ub77c \uc5c5\uacc4\uc758 \ud310\ub3c4\ub97c \ub4a4\ud754\ub4e4 \uc7a0\uc7ac\ub825\uc744 \uac00\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ubbf8 \ube44\uc758\ub8cc\uc6a9 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc5d0\uc11c \uadf8 \uc601\ud5a5\ub825\uc744 \ud655\uc778\ud560 \uc218 \uc788\uc73c\ubbc0\ub85c \uc758\ub8cc \uc0b0\uc5c5\uc5d0\uc11c \uadf8 \uc601\ud5a5\ub825\uc744 \ubc1c\ud718\ud558\ub294 \uac83\uc740 \uc2dc\uac04 \ubb38\uc81c\uc77c \ubfd0\uc785\ub2c8\ub2e4. \ub530\ub77c\uc11c \uc758\ub8cc \uae30\uae30\uc6a9 AI\/ML\uc744 \uaddc\uc81c, \uac1c\ubc1c \ubc0f \uad00\ub9ac\ud558\ub294 \ubc29\ubc95\uc5d0 \ub300\ud574 FDA, \uc5c5\uacc4 \ub2e8\uccb4 \ubc0f \uc804\ubb38\uac00\ub4e4\uc774 \uc9c0\uc18d\uc801\uc73c\ub85c \ub17c\uc758\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Q: 2024\ub144 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85 \uacfc\ud559 \uc0b0\uc5c5\uc758 \uaddc\uc81c\uc5d0 \ub300\ud574 \uc5b4\ub5bb\uac8c \uc608\uce21\ud558\uc2ed\ub2c8\uae4c? \uc774\ub7ec\ud55c \ud2b8\ub80c\ub4dc\uac00 5\ub144 \ud6c4\uc5d0\ub3c4 \uc5ec\uc804\ud788 \ub110\ub9ac \ud37c\uc9c8\uae4c\uc694? 10\ub144 \ud6c4\uc5d0\ub3c4?<\/h2>\n\n\n\n<p><strong><strong>Monterrey<\/strong><\/strong>: \uc791\ub144\uc5d0 \ub9d0\uc500\ub4dc\ub838\ub4ef\uc774, \uac00\uc774\ub4dc\ub77c\uc778\uacfc \ud45c\uc900\uc758 \uc870\ud654\uc5d0 \ub300\ud55c \uc9c4\uc804\uc774 \uc788\uc5b4 \uacb0\uad6d \uc2dc\ud310 \uc804 \uc2b9\uc778\uc5d0 \ub300\ud55c \ubcf4\ub2e4 \ud45c\uc900\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc774 \uac00\ub2a5\ud574\uc9c8 \uac83\uc73c\ub85c \ubcf4\uc774\uc9c0\ub9cc, \uc55e\uc11c \ub9d0\uc500\ub4dc\ub838\ub4ef\uc774 \uc774 \ubb38\uc81c\uac00 \ud574\uacb0\ub418\uae30 \uc804\uae4c\uc9c0\ub294 \uc9c0\uc800\ubd84\ud558\uace0 \ubcf5\uc7a1\ud560 \uac83\uc785\ub2c8\ub2e4. \uc800\ub294 \uc8fc\ub85c \uae30\uae30\ub97c \uac80\uc99d\ud558\ub294 \uc0c8\ub85c\uc6b4 \ubc29\ubc95\uc73c\ub85c \uc2dc\ubbac\ub808\uc774\uc158 \ubc0f \uc2e4\uc81c \ub370\uc774\ud130\uc758 \uc0ac\uc6a9\uc774 \uc99d\uac00\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ud569\ub2c8\ub2e4. \ub3d9\ubb3c \uc2e4\ud5d8\uacfc \uc778\uccb4 \ub0b4 \uc0ac\uc6a9\uc740 \uc904\uc5b4\ub4e4\uace0, \uacf5\uac1c\uc801\uc73c\ub85c \uc0ac\uc6a9 \uac00\ub2a5\ud558\uace0 \uac80\uc99d\ub41c \ub370\uc774\ud130 \uc138\ud2b8\ub97c \ud1b5\ud574 \uc0c8\ub85c\uc6b4 \uc758\ub8cc \uae30\uae30\uc758 \uc548\uc804\uc131\uacfc \ud6a8\ub2a5\uc744 \uc2e0\uc18d\ud558\uac8c \ud3c9\uac00\ud560 \uc218 \uc788\uac8c \ub420 \uac83\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<iframe loading=\"lazy\" title=\"Jama Connect\u00ae Features in Five: SaMD Framework\" width=\"770\" height=\"433\" src=\"https:\/\/www.youtube.com\/embed\/g9pHmkJOtxY?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" allowfullscreen><\/iframe>\n<\/div><\/figure>\n\n\n\n<p>\uac8c\uc2dc\ubb3c \uc791\uc131: Jama Software <\/p>\n\n\n\n<p>\uc18c\uc2a4: <a href=\"https:\/\/www.jamasoftware.com\/blog\/2024-predictions-for-medical-device-life-sciences-product-systems-and-software-development\" data-type=\"link\" data-id=\"https:\/\/www.jamasoftware.com\/blog\/2024-predictions-for-medical-device-life-sciences-product-systems-and-software-development\">2024 Predictions for Medical Device &amp; Life Sciences Product, Systems, and Software Development<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc804\ubb38\uac00\ub4e4\uc5d0\uac8c \ub0b4\ub144\uc5d0 \uc608\uc0c1\ub418\ub294 \uc758\ub8cc \uae30\uae30 \ubc0f \uc0dd\uba85\uacfc\ud559 \uc81c\ud488, \uc2dc\uc2a4\ud15c, \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud2b8\ub80c\ub4dc\uc5d0 \ub300\ud55c \uc758\uacac\uc744 \ubb3c\uc5c8\uc2b5\ub2c8\ub2e4<\/p>\n","protected":false},"author":7,"featured_media":2738,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[48],"tags":[45,72,51,90,52],"class_list":["post-2737","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-jama","tag-alm","tag-automotive","tag-jama","tag-medical-device","tag-requirements-management"],"_links":{"self":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts\/2737","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2737"}],"version-history":[{"count":3,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts\/2737\/revisions"}],"predecessor-version":[{"id":2752,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts\/2737\/revisions\/2752"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/media\/2738"}],"wp:attachment":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2737"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2737"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2737"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}