{"id":45480,"date":"2026-01-21T12:04:33","date_gmt":"2026-01-21T05:04:33","guid":{"rendered":"https:\/\/saigonbiz.com\/vn\/cac-san-pham-kinh-ap-trong-va-dung-dich-cham-soc-kinh-cua-clearlab-dat-chung-nhan-mdsap-iso-13485-va-eu-mdr-tu-dnv\/"},"modified":"2026-01-21T12:04:33","modified_gmt":"2026-01-21T05:04:33","slug":"cac-san-pham-kinh-ap-trong-va-dung-dich-cham-soc-kinh-cua-clearlab-dat-chung-nhan-mdsap-iso-13485-va-eu-mdr-tu-dnv","status":"publish","type":"post","link":"https:\/\/saigonbiz.com\/vn\/cac-san-pham-kinh-ap-trong-va-dung-dich-cham-soc-kinh-cua-clearlab-dat-chung-nhan-mdsap-iso-13485-va-eu-mdr-tu-dnv\/","title":{"rendered":"C\u00c1C S\u1ea2N PH\u1ea8M K\u00cdNH \u00c1P TR\u00d2NG V\u00c0 DUNG D\u1ecaCH CH\u0102M S\u00d3C K\u00cdNH C\u1ee6A CLEARLAB \u0110\u1ea0T CH\u1ee8NG NH\u1eacN MDSAP, ISO 13485 V\u00c0 EU MDR T\u1eea DNV"},"content":{"rendered":"
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H\u00ecnh th\u1ee9c \u0111\u00e1nh gi\u00e1 song song gi\u00fap t\u1ed1i \u01b0u quy tr\u00ecnh ch\u1ee9ng nh\u1eadn v\u00e0 \u0111\u1ea9y nhanh kh\u1ea3 n\u0103ng ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng to\u00e0n c\u1ea7u<\/span><\/b><\/p>\n

SINGAPORE, ng\u00e0y 21 th\u00e1ng 1 n\u0103m 2026 \/PRNewswire\/ — DNV, nha\u0300 cung c\u00e2\u0301p to\u00e0n c\u1ea7u \u0111\u1ed9c l\u1eadp trong l\u0129nh v\u1ef1c b\u1ea3o \u0111\u1ea3m v\u00e0 qu\u1ea3n l\u00fd r\u1ee7i ro, \u0111\u00e3 c\u1ea5p ch\u1ee9ng nh\u1eadn cho c\u00e1c s\u1ea3n ph\u1ea9m k\u00ednh \u00e1p tr\u00f2ng v\u00e0 ca\u0301c dung di\u0323ch ch\u0103m s\u00f3c k\u00ednh \u0111a n\u0103ng c\u1ee7a Clearlab theo Ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e1nh gi\u00e1 \u0111\u01a1n l\u1ebb thi\u1ebft b\u1ecb y t\u1ebf (MDSAP), H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 13485 d\u00e0nh cho thi\u1ebft b\u1ecb y t\u1ebf, v\u00e0 Quy \u0111\u1ecbnh thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u (MDR) 2017\/745.<\/p>\n

\n<\/p><\/div>\n

C\u00e1c ch\u1ee9ng nh\u1eadn n\u00e0y \u0111\u1ea1t \u0111\u01b0\u1ee3c th\u00f4ng qua h\u00ecnh th\u1ee9c \u0111\u00e1nh gi\u00e1 song song, cho ph\u00e9p Clearlab \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 \u0111\u1ed3ng th\u1eddi theo nhi\u1ec1u khung quy \u0111i\u0323nh kh\u00e1c nhau. C\u00e1ch ti\u1ebfp c\u1eadn t\u00edch h\u1ee3p n\u00e0y \u0111\u00e3 gi\u1ea3m \u0111\u00e1ng k\u1ec3 th\u1eddi gian v\u00e0 m\u1ee9c \u0111\u1ed9 ph\u1ee9c t\u1ea1p c\u1ee7a qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1, qua \u0111\u00f3 h\u1ed7 tr\u1ee3 quy tr\u00ecnh ch\u1ee9ng nh\u1eadn di\u1ec5n ra nhanh h\u01a1n v\u00e0 hi\u1ec7u qu\u1ea3 h\u01a1n.<\/p>\n

Thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u qu\u1ea3n l\u00fd nghi\u00eam ng\u1eb7t nh\u1eb1m ch\u1ee9ng minh t\u00ednh an to\u00e0n v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. Do m\u1ed7i th\u1ecb tr\u01b0\u1eddng \u00e1p d\u1ee5ng m\u1ed9t khung quy \u0111\u1ecbnh ri\u00eang, vi\u1ec7c \u0111\u1ea1t ch\u1ee9ng nh\u1eadn t\u1ea1i nhi\u1ec1u th\u1ecb tr\u01b0\u1eddng co\u0301 th\u00ea\u0309 ph\u1ee9c t\u1ea1p v\u00e0 t\u1ed1n nhi\u1ec1u th\u1eddi gian. \u0110\u1ec3 gi\u1ea3i quy\u1ebft th\u00e1ch th\u1ee9c n\u00e0y, c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd t\u1ea1i Australia, Brazil, Canada, Nh\u1eadt B\u1ea3n v\u00e0 Hoa K\u1ef3 \u0111\u00e3 pha\u0301t tri\u00ea\u0309n MDSAP d\u1ef1a tr\u00ean ti\u00eau chu\u1ea9n ISO 13485. Theo MDSAP, m\u1ed9t cu\u1ed9c \u0111\u00e1nh gi\u00e1 theo quy \u0111i\u0323nh duy nh\u1ea5t c\u00f3 th\u1ec3 cung c\u00e2\u0301p quy\u00ea\u0300n ti\u1ebfp c\u1eadn t\u1edbi n\u0103m th\u1ecb tr\u01b0\u1eddng n\u00e0y, c\u0169ng nh\u01b0 c\u00e1c qu\u1ed1c gia th\u00e0nh vi\u00ean li\u00ean k\u1ebft. T\u01b0\u01a1ng t\u1ef1, vi\u1ec7c tu\u00e2n th\u1ee7 EU MDR cho ph\u00e9p doanh nghi\u1ec7p ti\u1ebfp c\u1eadn to\u00e0n b\u1ed9 th\u1ecb tr\u01b0\u1eddng Li\u00ean minh ch\u00e2u \u00c2u v\u00e0 Khu v\u1ef1c Kinh t\u1ebf ch\u00e2u \u00c2u.<\/p>\n

V\u1edbi vai tr\u00f2 l\u00e0 T\u1ed5 ch\u1ee9c \u0111\u00e1nh gi\u00e1 MDSAP v\u00e0 \u0111\u1ed3ng th\u1eddi l\u00e0 T\u00f4\u0309 ch\u01b0\u0301c \u0111\u01b0\u01a1\u0323c chi\u0309 \u0111i\u0323nh theo quy \u0111i\u0323nh cu\u0309a EU, DNV \u0111\u01b0\u1ee3c u\u0309y quy\u00ea\u0300n th\u1ef1c hi\u1ec7n \u0111\u00e1nh gi\u00e1 cho c\u1ea3 hai ch\u01b0\u01a1ng tri\u0300nh ch\u1ee9ng nh\u1eadn n\u00e0y, qua \u0111\u00f3 gi\u00fap c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ti\u1ebfp c\u1eadn hi\u1ec7u qu\u1ea3 c\u00e1c th\u1ecb tr\u01b0\u1eddng l\u01a1\u0301n tr\u00ean to\u00e0n c\u1ea7u.<\/p>\n

Nh\u1eb1m h\u1ed7 tr\u1ee3 Clearlab \u0111\u01b0a c\u00e1c s\u1ea3n ph\u1ea9m k\u00ednh \u00e1p tr\u00f2ng v\u00e0 dung d\u1ecbch ch\u0103m s\u00f3c k\u00ednh \u0111a n\u0103ng ch\u1ea5t l\u01b0\u1ee3ng cao, mang t\u00ednh \u0111\u1ed5i m\u1edbi \u0111\u1ebfn v\u1edbi c\u01a1 s\u01a1\u0309 ng\u01b0\u1eddi ti\u00eau d\u00f9ng tr\u00ean ph\u1ea1m vi r\u1ed9ng l\u01a1\u0301n h\u01a1n m\u00f4\u0323t ca\u0301ch nhanh cho\u0301ng h\u01a1n, DNV \u0111\u00e3 ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee7a Clearlab theo y\u00eau c\u1ea7u c\u1ee7a MDSAP, ISO 13485 v\u00e0 EU MDR trong m\u1ed9t quy tr\u00ecnh \u0111\u00e1nh gi\u00e1 song song. C\u00e1ch ti\u1ebfp c\u1eadn ti\u0301ch h\u01a1\u0323p n\u00e0y gi\u1ea3m thi\u1ec3u s\u1ef1 tr\u00f9ng l\u1eb7p v\u00e0 g\u00e1nh n\u1eb7ng \u0111\u00e1nh gi\u00e1 cho nh\u00e0 s\u1ea3n xu\u1ea5t, \u0111\u1ed3ng th\u1eddi mang l\u1ea1i t\u00ednh linh ho\u1ea1t cao h\u01a1n \u0111\u00ea\u0309 t\u1ed1i \u01b0u h\u00f3a th\u1eddi gian \u0111\u01b0a s\u1ea3n ph\u1ea9m ra th\u1ecb tr\u01b0\u1eddng<\/span>.<\/p>\n

“B\u0103\u0300ng ca\u0301ch \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u c\u1ee7a MDSAP, ISO 13485 v\u00e0 MDR th\u00f4ng qua m\u1ed9t quy tr\u00ecnh \u0111\u00e1nh gi\u00e1 duy nh\u1ea5t, Clearlab c\u1ee7ng c\u1ed1 v\u1eefng ch\u1eafc n\u0103ng l\u1ef1c tu\u00e2n th\u1ee7 v\u00e0 \u0111\u1ea9y nhanh kh\u1ea3 n\u0103ng ti\u1ebfp c\u1eadn c\u00e1c th\u1ecb tr\u01b0\u1eddng to\u00e0n c\u1ea7u tr\u1ecdng \u0111i\u1ec3m, bao g\u1ed3m ch\u00e2u \u00c2u, khu v\u1ef1c ch\u00e2u \u00c1 \u2013 Th\u00e1i B\u00ecnh D\u01b0\u01a1ng v\u00e0 c\u00e1c khu v\u1ef1c \u0111\u01b0\u01a1\u0323c qua\u0309n ly\u0301 kh\u00e1c. Nh\u1eefng ch\u1ee9ng nh\u1eadn n\u00e0y kh\u1eb3ng \u0111\u1ecbnh r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m k\u00ednh \u00e1p tr\u00f2ng v\u00e0 ch\u0103m s\u00f3c k\u00ednh c\u1ee7a Clearlab \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn v\u1ec1 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng, an to\u00e0n v\u00e0 tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh. Th\u00e0nh c\u00f4ng n\u00e0y la\u0300m n\u00f4\u0309i b\u00e2\u0323t gi\u00e1 tr\u1ecb c\u1ee7a c\u00e1c cu\u1ed9c \u0111\u00e1nh gi\u00e1 \u0111\u01b0\u1ee3c ph\u1ed1i h\u1ee3p trong vi\u1ec7c h\u1ed7 tr\u1ee3 c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ecbnh h\u01b0\u1edbng trong b\u1ed1i c\u1ea3nh quy \u0111\u1ecbnh ng\u00e0y c\u00e0ng ph\u1ee9c t\u1ea1p, \u0111\u1ed3ng th\u1eddi v\u1eabn duy tr\u00ec ti\u00eau chu\u1ea9n cao v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m v\u00e0 an to\u00e0n cho ng\u01b0\u1eddi b\u1ec7nh”, ba\u0300 Hae Kyeung Park, Gi\u00e1m \u0111\u1ed1c \u0111i\u1ec1u h\u00e0nh cu\u0309a Clearlab cho bi\u1ebft.<\/p>\n

“M\u1ed9t trong nh\u1eefng th\u00e1ch th\u1ee9c l\u1edbn nh\u1ea5t \u0111\u1ed1i v\u1edbi c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ed5i m\u1edbi pha\u0309i \u0111\u00f4\u0301i m\u0103\u0323t l\u00e0 th\u1eddi gian c\u1ea7n thi\u1ebft \u0111\u1ec3 \u0111\u1ea1t ch\u1ee9ng nh\u1eadn sa\u0309n ph\u00e2\u0309m t\u1ea1i t\u1ea5t c\u1ea3 c\u00e1c th\u1ecb tr\u01b0\u1eddng m\u1ee5c ti\u00eau, c\u0169ng nh\u01b0 t\u00e1c \u0111\u1ed9ng c\u1ee7a \u0111i\u1ec1u n\u00e0y \u0111\u1ed1i v\u1edbi k\u1ebf ho\u1ea1ch tri\u1ec3n khai to\u00e0n c\u1ea7u. C\u00e1c cu\u1ed9c \u0111\u00e1nh gi\u00e1 song song theo nhi\u1ec1u ti\u00eau chu\u1ea9n c\u00f3 th\u1ec3 t\u1ea1o ra s\u1ef1 kh\u00e1c bi\u1ec7t th\u1ef1c s\u1ef1. Ch\u00fang t\u00f4i r\u1ea5t vui khi \u0111\u00e3 h\u1ed7 tr\u1ee3 Clearlab trong vi\u00ea\u0323c \u0111\u01b0a c\u00e1c s\u1ea3n ph\u1ea9m k\u00ednh \u00e1p tr\u00f2ng c\u1ee7a h\u1ecd ra th\u1ecb tr\u01b0\u1eddng r\u1ed9ng l\u1edbn h\u01a1n nhanh h\u01a1n, nh\u1edd s\u01b0\u0323 giao ti\u00ea\u0301p ch\u1eb7t ch\u1ebd v\u00e0 k\u1ebf ho\u1ea1ch \u0111\u00e1nh gi\u00e1 \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf phu\u0300 h\u01a1\u0323p, do \u0111\u1ed9i ng\u0169 \u0111\u1ecba ph\u01b0\u01a1ng c\u1ee7a ch\u00fang t\u00f4i tri\u1ec3n khai”, ba\u0300 Cecilie Gudesen Torp, Gi\u00e1m \u0111\u1ed1c D\u1ecbch v\u1ee5 Y t\u1ebf To\u00e0n c\u1ea7u, DNV cho bi\u1ebft th\u00eam.<\/p>\n

T\u00ecm hi\u1ec3u th\u00eam t\u1ea1i https:\/\/www.dnv.com\/medical-devices\/<\/a>\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

H\u00ecnh th\u1ee9c \u0111\u00e1nh gi\u00e1 song song gi\u00fap t\u1ed1i \u01b0u quy tr\u00ecnh ch\u1ee9ng nh\u1eadn v\u00e0 \u0111\u1ea9y nhanh kh\u1ea3 n\u0103ng ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng to\u00e0n c\u1ea7u SINGAPORE, ng\u00e0y 21 th\u00e1ng 1 n\u0103m 2026 \/PRNewswire\/ — DNV, nha\u0300 cung c\u00e2\u0301p to\u00e0n c\u1ea7u \u0111\u1ed9c l\u1eadp trong l\u0129nh v\u1ef1c b\u1ea3o \u0111\u1ea3m v\u00e0 qu\u1ea3n l\u00fd r\u1ee7i ro, \u0111\u00e3 c\u1ea5p ch\u1ee9ng nh\u1eadn […]\n","protected":false},"author":2604,"featured_media":50415,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[2293],"tags":[],"class_list":["post-45480","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"\nC\u00c1C S\u1ea2N PH\u1ea8M K\u00cdNH \u00c1P TR\u00d2NG V\u00c0 DUNG D\u1ecaCH CH\u0102M S\u00d3C K\u00cdNH C\u1ee6A CLEARLAB \u0110\u1ea0T CH\u1ee8NG NH\u1eacN MDSAP, ISO 13485 V\u00c0 EU MDR T\u1eea DNV<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/saigonbiz.com\/vn\/cac-san-pham-kinh-ap-trong-va-dung-dich-cham-soc-kinh-cua-clearlab-dat-chung-nhan-mdsap-iso-13485-va-eu-mdr-tu-dnv\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"C\u00c1C S\u1ea2N PH\u1ea8M K\u00cdNH \u00c1P TR\u00d2NG V\u00c0 DUNG D\u1ecaCH CH\u0102M S\u00d3C K\u00cdNH C\u1ee6A CLEARLAB \u0110\u1ea0T CH\u1ee8NG NH\u1eacN MDSAP, ISO 13485 V\u00c0 EU MDR T\u1eea DNV\" \/>\n<meta property=\"og:description\" content=\"H\u00ecnh th\u1ee9c \u0111\u00e1nh gi\u00e1 song song gi\u00fap t\u1ed1i \u01b0u quy tr\u00ecnh ch\u1ee9ng nh\u1eadn v\u00e0 \u0111\u1ea9y 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