{"id":2816,"date":"2024-02-27T15:33:09","date_gmt":"2024-02-27T06:33:09","guid":{"rendered":"https:\/\/alm.engineering\/?p=2816"},"modified":"2024-02-27T15:49:00","modified_gmt":"2024-02-27T06:49:00","slug":"%eb%af%b8%eb%9e%98%eb%a5%bc-%ed%96%a5%ed%95%9c-%ed%95%ad%ed%95%b4-fda-iso-13485%ec%99%80-21-cfr-part-820%ec%9d%98-%ec%a1%b0%ed%99%94","status":"publish","type":"post","link":"https:\/\/alm.engineering\/?p=2816","title":{"rendered":"\ubbf8\ub798\ub97c \ud5a5\ud55c \ud56d\ud574: FDA ISO 13485\uc640 21 CFR Part 820\uc758 \uc870\ud654"},"content":{"rendered":"\n<figure class=\"wp-block-image size-full is-style-default\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"512\" src=\"https:\/\/alm.engineering\/wp-content\/uploads\/2024\/02\/image-3.png\" alt=\"\" class=\"wp-image-2817\" srcset=\"https:\/\/alm.engineering\/wp-content\/uploads\/2024\/02\/image-3.png 1024w, https:\/\/alm.engineering\/wp-content\/uploads\/2024\/02\/image-3-300x150.png 300w, https:\/\/alm.engineering\/wp-content\/uploads\/2024\/02\/image-3-768x384.png 768w, https:\/\/alm.engineering\/wp-content\/uploads\/2024\/02\/image-3-370x185.png 370w, https:\/\/alm.engineering\/wp-content\/uploads\/2024\/02\/image-3-270x135.png 270w, https:\/\/alm.engineering\/wp-content\/uploads\/2024\/02\/image-3-570x285.png 570w, https:\/\/alm.engineering\/wp-content\/uploads\/2024\/02\/image-3-740x370.png 740w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>Jama Software\ub294 \uc5c5\uacc4 \ud30c\ud2b8\ub108\uc5d0\uac8c \ub3c4\uc6c0\uc774 \ub420 \ub9cc\ud55c \uc18c\uc2dd\uc744 \ud56d\uc0c1 \ucc3e\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\uc5d0 \ub530\ub77c, \uc6b0\ub9ac\ub294 \ud1b5\ucc30\ub825 \uc788\ub294 \uace0\uac1d \ubc0f \uc5c5\uacc4 \uc2a4\ud3ec\ud2b8\ub77c\uc774\ud2b8 \uae30\uc0ac \uc2dc\ub9ac\uc988\ub97c \uc815\ub9ac\ud588\uc2b5\ub2c8\ub2e4. \uc774 \ube14\ub85c\uadf8 \uac8c\uc2dc\ubb3c\uc5d0\uc11c\ub294 Scilife\uc5d0\uc11c \ubc1c\ucdcc\ud55c \uae30\uc0ac, &#8220;FDA ISO 13485 \ubc0f 21 CFR Part 820 \uc870\ud654 \uac1c\uc694&#8221;\ub97c \uacf5\uc720\ud569\ub2c8\ub2e4. \uc774 \uae30\uc0ac\ub294 Angel Buendia\uac00 \uc791\uc131\ud558\uace0 2023\ub144 3\uc6d4 31\uc77c\uc5d0 \ucc98\uc74c \ubc1c\ud589\ub418\uc5c8\uc73c\uba70 2024\ub144 1\uc6d4 3\uc77c\uc5d0 \uc5c5\ub370\uc774\ud2b8\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>FDA ISO 13485 \ubc0f 21 CFR Part 820 \uc870\ud654 \uac1c\uc694<\/strong> \ubbf8\uad6d FDA(Food and Drug Administration, \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\uccad)\ub294 \uc5ec\ub7ec \uac00\uc9c0\ub85c \uc798 \uc54c\ub824\uc838 \uc788\uc2b5\ub2c8\ub2e4. \ud558\uc9c0\ub9cc, \uc801\uc751\uc131\uacfc \ub2e4\ub978 \uc804 \uc138\uacc4 \uaddc\uc81c \uae30\uad00\uacfc\uc758 \uc870\ud654\ub97c \uc774\ub8e8\ub824\ub294 \uc758\uc9c0\ub294 \uadf8\uc911 \ud558\ub098\uac00 \uc544\ub2d0 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uadf8\ub7fc\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0, 2018\ub144 FDA\ub294 \ubbf8\uad6d\uc758 \ud488\uc9c8 \uc2dc\uc2a4\ud15c \uaddc\uc815(Quality System Regulation, QSR, \ubbf8\uad6d \uc5f0\ubc29 \uaddc\uc815 \ucf54\ub4dc 21 \ubd80\ubd84 820\uc5d0 \uc124\uba85\ub428)\uc744 \uad6d\uc81c \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c \ud45c\uc900\uc778 ISO 13485 \uc758\ub8cc\uae30\uae30 &#8211; \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c &#8211; \uaddc\uc81c \ubaa9\uc801\uc744 \uc704\ud55c \uc694\uad6c\uc0ac\ud56d\uacfc \uc870\ud654\uc2dc\ud0a4\uae30 \uc704\ud55c \uc791\uc5c5\uc744 \uc2dc\uc791\ud588\uc2b5\ub2c8\ub2e4. 2022\ub144 2\uc6d4 23\uc77c, FDA\ub294 \uc5f0\ubc29 \uad00\ubcf4\uc5d0 \uc81c\uc548\ub41c \uaddc\uce59\uc744 \ubc1c\ud45c\ud558\uba70, \ud488\uc9c8 \uc2dc\uc2a4\ud15c \uaddc\uc815(QSR)\uc744 \uc0c8\ub85c\uc6b4 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c \uaddc\uc815(QSMR)\uc73c\ub85c \ub300\uccb4\ud560 \uc758\ub3c4\ub97c \uc120\uc5b8\ud588\uc2b5\ub2c8\ub2e4. FDA\ub294 \uc758\ub8cc\uae30\uae30 \ub2e8\uc77c \uac10\uc0ac \ud504\ub85c\uadf8\ub7a8(MDSAP)\uc744 \ud1b5\ud574 ISO 13485 \uc694\uad6c\uc0ac\ud56d\uc5d0 \ub530\ub978 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc758 \uac80\uc0ac\ub97c \ud5c8\uc6a9\ud558\ub294 \uac83\uc744 \ud1b5\ud574 \ucc98\uc74c\uc73c\ub85c &#8220;\uc758\ub8cc\uae30\uae30\uc758 QMS\ub97c \uc124\uc815\ud558\uae30 \uc704\ud55c \ud3ec\uad04\uc801\uc774\uace0 \ud6a8\uacfc\uc801\uc778 \uc811\uadfc \ubc29\uc2dd&#8221;\uc744 \uc778\uc2dd\ud588\ub2e4\uace0 \uac15\uc870\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>\ubbf8\uad6d \ud488\uc9c8 \uc2dc\uc2a4\ud15c \uaddc\uc815(QSR)<\/strong> \ubbf8\uad6d \ud488\uc9c8 \uc2dc\uc2a4\ud15c \uaddc\uc815\uc740 \ubbf8\uad6d\uc5d0 \uae30\ubc18\uc744 \ub454 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc758 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc694\uad6c\uc0ac\ud56d\uc744 \uc124\uba85\ud569\ub2c8\ub2e4. 1997\ub144\uc5d0 \ub3c4\uc785\ub418\uc5b4 25\ub144\uc774 \ub118\uc5c8\uc2b5\ub2c8\ub2e4. \uaddc\uc815\uc740 \ucc98\uc74c\uc5d0 ISO13485:1996\uacfc \ub9ce\uc740 \uac1c\ub150\uc744 \uacf5\uc720\ud588\uc9c0\ub9cc, \uc5ec\uc804\ud788 \uc5c5\uacc4\uc758 \ubcc0\ud654\ub97c \ucda9\ubd84\ud788 \ubc18\uc601\ud558\uae30 \uc704\ud574 \uc5c5\ub370\uc774\ud2b8\ub418\uc9c0 \uc54a\uc558\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>2018\ub144\uc5d0 \uc791\uc5c5\uc744 \uc2dc\uc791\ud560 \uc608\uc815\uc774\uc5c8\uc9c0\ub9cc, \uc5c5\ub370\uc774\ud2b8\uc758 \ubcf5\uc7a1\uc131\uacfc \uc804 \uc138\uacc4\uc801\uc778 \ub300\uc720\ud589\uc73c\ub85c \uc778\ud574 \uc870\ud654 \uc791\uc5c5\uc774 \uc9c0\uc5f0\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \ud558\uc9c0\ub9cc, \uc6b0\ub9ac\ub294 \uace7 \ucd5c\uc885 \uaddc\uce59\uc744 \ubcfc \uc218 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>ISO 13485<\/strong> ISO 13485:2016\uc740 \uc758\ub8cc\uae30\uae30 \ud68c\uc0ac\ub97c \uc704\ud55c \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc694\uad6c\uc0ac\ud56d\uc744 \uc124\uba85\ud569\ub2c8\ub2e4. ISO 9001 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \uae30\ubc18\uc73c\ub85c \ud55c ISO 13485\ub294 \uc758\ub8cc\uae30\uae30 \uc5c5\uacc4\uc758 \ud2b9\uc815 \uc694\uad6c\uc0ac\ud56d\uc5d0 \uc911\uc810\uc744 \ub461\ub2c8\ub2e4. \ucd5c\uadfc \ubc84\uc804\uc740 2016\ub144\uc5d0 \ubc1c\ud45c\ub418\uc5c8\uc73c\uba70, \uc758\ub8cc\uae30\uae30\uc758 \uc124\uacc4, \uac1c\ubc1c, \uc0dd\uc0b0, \uc124\uce58 \ubc0f \uc11c\ube44\uc2a4 \uc81c\uacf5\uacfc \uad00\ub828\ub41c \uacf5\uc815\uc744 \ub2e4\ub8f9\ub2c8\ub2e4.<\/p>\n\n\n\n<p>ISO 13485\ub294 \uc804 \uc138\uacc4\uc801\uc73c\ub85c \uc778\uc815\ubc1b\ub294 \ud45c\uc900\uc73c\ub85c, \uc5ec\ub7ec \uad6d\uac00\uc5d0\uc11c \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc5d0 \ub300\ud55c \uaddc\uc81c \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\uc2dc\ud0a4\ub294 \ub370 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \uc81c\ud488 \uc548\uc804\uacfc \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud55c \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud558\uba70, \uc774\ub294 \ucd5c\uc885 \uc0ac\uc6a9\uc790\uc5d0\uac8c \uc9c1\uc811\uc801\uc778 \uc774\uc775\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p><\/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=\"Elevating Your Medical Device and Life Sciences Product Development Processes [PREVIEW]\" width=\"770\" height=\"433\" src=\"https:\/\/www.youtube.com\/embed\/dhZ5hydrD_o?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><strong>\uc870\ud654\uc758 \uc774\uc810<\/strong> FDA\uac00 ISO 13485\ub97c \ucc44\ud0dd\ud558\uba74 \uc5ec\ub7ec \uac00\uc9c0 \uc774\uc810\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uac00\uc7a5 \uc911\uc694\ud55c \uac83\uc740, \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uac00 \uc804 \uc138\uacc4\uc801\uc73c\ub85c \uc77c\uad00\ub41c \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \uad6c\ucd95\ud560 \uc218 \uc788\ub2e4\ub294 \uac83\uc785\ub2c8\ub2e4. \uc774\ub294 \ube44\uc6a9 \uc808\uac10, \ud6a8\uc728\uc131 \uc99d\uac00, \uadf8\ub9ac\uace0 \uc81c\ud488\uc758 \uae00\ub85c\ubc8c \uc2dc\uc7a5 \uc9c4\uc785 \uc18d\ub3c4\ub97c \uac00\uc18d\ud654\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4. \ub610\ud55c, \uc774\ub7ec\ud55c \uc870\ud654\ub294 \uc758\ub8cc\uae30\uae30\uc758 \uc548\uc804\uc131\uacfc \ud6a8\uacfc\uc131\uc744 \ud5a5\uc0c1\uc2dc\ud0a4\ub294 \ub370 \uc911\uc694\ud55c \uc5ed\ud560\uc744 \ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>\uacb0\ub860<\/strong> FDA\uc758 ISO 13485\uc640 21 CFR Part 820\uc758 \uc870\ud654\ub294 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc5d0\uac8c \uc911\uc694\ud55c \ubcc0\ud654\ub97c \uac00\uc838\uc62c \uac83\uc785\ub2c8\ub2e4. \uc774 \ubcc0\ud654\ub294 \uaddc\uc81c \uc900\uc218\uc758 \ubcf5\uc7a1\uc131\uc744 \uc904\uc774\uace0, \uc81c\ud488\uc758 \ud488\uc9c8\uc744 \ud5a5\uc0c1\uc2dc\ud0a4\uba70, \uc804 \uc138\uacc4 \uc2dc\uc7a5\uc5d0 \ub354 \uc27d\uac8c \uc811\uadfc\ud560 \uc218 \uc788\uac8c \ud574\uc904 \uac83\uc785\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ubcc0\ud654\ub97c \ud1b5\ud574 \uc758\ub8cc\uae30\uae30 \uc0b0\uc5c5\uc774 \ub354\uc6b1 \ubc1c\uc804\ud558\uace0, \ud658\uc790\uc758 \uc548\uc804\uacfc \ubcf5\uc9c0\uac00 \uac1c\uc120\ub418\uae30\ub97c \uae30\ub300\ud569\ub2c8\ub2e4.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jama Software\ub294 \uc5c5\uacc4 \ud30c\ud2b8\ub108\uc5d0\uac8c \ub3c4\uc6c0\uc774 \ub420 \ub9cc\ud55c \uc18c\uc2dd\uc744 \ud56d\uc0c1 \ucc3e\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\uc5d0 \ub530\ub77c, \uc6b0\ub9ac\ub294 \ud1b5\ucc30\ub825 \uc788\ub294 \uace0\uac1d \ubc0f \uc5c5\uacc4 \uc2a4\ud3ec\ud2b8\ub77c\uc774\ud2b8 \uae30\uc0ac \uc2dc\ub9ac\uc988\ub97c \uc815\ub9ac\ud588\uc2b5\ub2c8\ub2e4. \uc774 \ube14\ub85c\uadf8 \uac8c\uc2dc\ubb3c\uc5d0\uc11c\ub294 Scilife\uc5d0\uc11c \ubc1c\ucdcc\ud55c \uae30\uc0ac, &#8220;FDA ISO 13485 \ubc0f 21 CFR Part 820 \uc870\ud654 \uac1c\uc694&#8221;\ub97c \uacf5\uc720\ud569\ub2c8\ub2e4. \uc774 \uae30\uc0ac\ub294 Angel Buendia\uac00 \uc791\uc131\ud558\uace0 2023\ub144 3\uc6d4 31\uc77c\uc5d0 \ucc98\uc74c \ubc1c\ud589\ub418\uc5c8\uc73c\uba70 2024\ub144 1\uc6d4 3\uc77c\uc5d0 \uc5c5\ub370\uc774\ud2b8\ub418\uc5c8\uc2b5\ub2c8\ub2e4. FDA [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":2817,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[48],"tags":[45,72,73,51,53],"class_list":["post-2816","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-jama","tag-alm","tag-automotive","tag-engineering","tag-jama","tag-systems-engineering"],"_links":{"self":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts\/2816","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2816"}],"version-history":[{"count":2,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts\/2816\/revisions"}],"predecessor-version":[{"id":2819,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts\/2816\/revisions\/2819"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/media\/2817"}],"wp:attachment":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2816"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2816"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2816"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}