ࡱ> Root Entry C!`o$FileHeaderTDocInfoIBodyTextP`oP`o !"#$%'(&)*+,-.Root EntryB_o$FileHeaderTDocInfoIBodyText}@_o}@_o / !"#$%&'()*+,-./0123456789:;<=>?@ACDEFGHJKLMNOPQRSXUVWZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~HwpSummaryInformation.BPrvImage EPrvTextSection0Y8<ոƴ| hXՔ X̸00X Quality Evaluation of Medical Device contained Software Minyong Choi*, Youngkyu Kang*, Jeongrim Lee*, Hyeogju Kim* * Department of Medical Device and Radiation Health, Korea Food and Drug Administration, Seoul 122-704, sirmin@kfda.go.kr Abstract: To use software more safely in the medical field, we need the system that evaluate and manage the quality of the medical software in the national level. To evaluate the quality of the medical software, firstly it is needed to examine and analyze the status relating to the quality of the medical software, then, Quality Evaluation System should be constructed. At this research, we carried the investigation about Quality Management & the status of medical software with designing 9 survey area for the company manufacturing or importing the medical software. And we carried the pilot Quality Evaluation to set up the foothold of substantial medical software evaluation and studied the problem, defect, and improvement of the evaluation based on ISO >GIF89atɻxxxkkk]]]PPPCCC555((( d`LH00`Hذ̘`H0|pdXL@`0H `H0`dHL`H0xp`XH@0d LȰ``HH00dLؘȀ`H0xp`XH@d0L `H0d`LH`H0|pdXL@0`$H`dHL00`HذȘdL0xp`XH@0` HdH0ȳ``HHdL0xp`XH@`0H Ը̰ĠऀؘpȈXxHp@h@d8`8X0xT0pH dxddxd`d`p`|``x`p``x`!,t H*\ȰÇ#JHŋ3jȱǏ CIɓ(S\ɲ˗0cʜI͛8s?=9hPA UQEH)өK6ʵׯ(Nj)YZ2}Z*MHU*ݹ`WZQ]*p wpATb˙\U=qvDͺȑ;#܌콥ױ`ѹK[''G 1üC hXy˕MMns&?賈{u]o{d4}'^sY]y_~vٗYY^[эdiMH"gQ#fFz!bW bD8|iEx[ᕛv*g݀g}CNwTFڄh=YX{on葇d"'1]_v?TԵgV8is']=-z%>ZV ˕]}8eYA"[BZ`1h\|u餮&8'iFj֙auy#w*%܆yczdn:yhLVchkzad1Ӹjc{-l֖^k@eLx ﻜ6%"lXtv7.V(b↮X&9#:\wNrB]v4؝!;Mib%Z ;w-Abޤcnn U>,]]7sӜ҃,- +|3(lwe{n&|o2ڭ|Dߊk2Ilm]Mtnl3.^,m첵4kWz//Qh;Vpz4Rӵv08բE*F-Kx?Z Ƽ"ڹW>p0c4vэjf5,N4U!P1kvr'`qQ9@'-0vw`k3ǺdЂ[?)bBfJ[Fth-Աm5j7EL5\Qv? @ǭ "~Z} ٤U%BP#gf=1'c"-~\HE$3V6DDvTh=Nʒtƺ̔ZS8K.ѳ:ГI'*rcb ,c'2J@"ٔ:~FT z#3 ThѝQ'6JwNɂMBІ:D;`a``a`0u h`a``a`0u h   D P \h Y ] 2002D 6 20| | $ 8:08:09  min5, 7, 6, 3018 6@o@}@_o@ZzЂHz!łjV=hQݛ=tsrF6*F!b!!zjj!lHXYQ$ xH O*e 8gvfm^syE;}:k$^n$*Z?979ϋj7ϋXJoYJnGħVE ?x V/ʾoh{^ON-*u-_zٛ[S}*9μu}{o+ۼeˎ@Z'V癵P?)cgQUߝWףcHU^MY": EsVȷ)VO=&WoF\Ƅ/q%Dz|ܒk/(ZRD u7Wdƶ'}Y$(O/KJ4_ނ>zkk%\$loCZ\ߺ6k>+ Ꙣ5Y#-X{/eL@f(w&pښ~ÄFd5()֛,E?xk1'l4/׃mx@|*>yDЏ~7ecRPecJy(mo"xvJ üљcNumנb2S5oQwW Ciy3z>ꘪ kA<3k2~;^^58sh,I5H7dјl-m+x;^LuKyYWoOMU½TUٟTuu>3"Om1f娳\G$k}qI;ߤ$׋Z,䑮t*ԓ)ly37>l2homT=(3sS#V*{_( y ZeCR1tIvE09%е .k_y 2:ZRkbіtGwvfLU".URVkG֏k(mgCA[h0L,~P}^TγwAZ*2 9N~[L咭{ v:U=8ύYYIK>2:9Z$97⎃y$<pw7/1%/~zyywe"ON?o!K_%̹AO|s4)IAyZ;ST|Э4hè2b QSӓ= ;5iqJj}ؗh RBH>}IdA/A1Z$U ƴnwn_ bjI{>Fq_NBKnDA:^; +S_Q#Ⱦ#ҫknTz!{nG1%S;$$;zw̯9#0m0v37o-Qqa|3w/ a*'"s{v^bwkn,&築v!:ӈ'ލ;v2cĊvc?8?Lc'M}ΈӖ\ݟ 3ctb\مI|w{\|(+?f3yV "*TIJQ"bhmvKHK?13|H*[*HkI*ixPg|B'fO3iRHedy^aozm}y^S8WK2'kOjF+X?f> Z29c ׉x8` R|SJUЧ1LF&tuN::X܇Ց|\ +][%MzLt0גǯkG,gΟ{ɹͬƾsGG%_ѣfoz 0Zɿ=<3b=zxn'5UTN Gñ_u^ ;}__GUEp*#7=;n5CS@G.wI\™R$͂=Z,V9zﳽ֋$X@?@ACDEFGHJKLMNOPQRSXUVWZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~HwpSummaryInformation.BPrvImage GPrvTextSection0YJ<ոƴ| hXՔ X̸00X Quality Evaluation of Medical Device contained Software Minyong Choi*, Youngkyu Kang*, Jeongrim Lee*, Hyeogju Kim* * Department of Medical Device and Radiation Health, Korea Food and Drug Administration, Seoul 122-704, sirmin@kfda.go.kr Abstract: To use software more safely in the medical field, we need the system that evaluate and manage the quality of the medical software in the national level. To evaluate the quality of the medical software, firstly it is needed to examine and analyze the status relating to the quality of the medical software, then, Quality Evaluation System should be constructed. At this research, we carried the investigation about Quality Management & the status of medical software with designing 9 survey area for the company manufacturing or importing the medical software. 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