위험 관리
?덉쟾? ?ㅺ퀎?⑸땲?? (Safety is Engineered, Not Just Documented.)
ISO 14971? ?⑥닚??泥댄겕由ъ뒪?멸? ?꾨떃?덈떎. Hazard Analysis遺??FMEA, ?붿뿬 ?꾪뿕 ?됯?源뚯?. ?쒗뭹???덉쟾?깆쓣 ?ㅺ퀎 ?④퀎遺???댁옱?뷀븯??**Risk Management File (RMF)**??援ъ텞?⑸땲??
The Challenge
Lifecycle Approach
?ㅺ퀎(Design), 怨듭젙(Process), ?뚰봽?몄썾??Software), ?ъ슜??Usability) ?꾪뿕 遺꾩꽍???듯빀 愿由ы븯???ш컖吏?瑜??놁빋?덈떎.
Benefit-Risk Analysis
?쒗뭹???붿뿬 ?꾪뿕(Residual Risk)???꾩긽???대뱷(Benefit)蹂대떎 ??떎??寃껋쓣 利앸챸?섎뒗 ?뺢탳???쇰━瑜?媛쒕컻?⑸땲??
Post-Market Loop
?쒗뙋 ???섏쭛???댁긽 ?щ?(PMS)媛 ?ㅼ떆 ?꾪뿕 愿由??뚯씪(RMF)濡??쇰뱶諛깅릺??'Living Risk Management' 猷⑦봽瑜??꾩꽦?⑸땲??
자주 묻는 질문
FMEA留??덉쑝硫??섎굹??
?꾨땲?? FMEA???꾪뿕 遺꾩꽍???꾧뎄??肉먯엯?덈떎. Hazard Analysis? ?꾪뿕 ?대뱷 遺꾩꽍??諛섎뱶???ы븿?섏뼱???⑸땲??
?뚰봽?몄썾???꾪뿕 愿由щ룄 ?ы븿?섎굹??
?? IEC 62304???곕Ⅸ ?뚰봽?몄썾???덉쟾???깃툒 遺꾨쪟? ?꾪뿕 ?듭젣瑜??섑뻾?⑸땲??
?몄젣 ?낅뜲?댄듃?댁빞 ?섎굹??
?ㅺ퀎 蹂寃??? ?뱀? ?쒗뙋 ???덈줈??遺?묒슜??諛쒓껄???뚮쭏??利됱떆 ?낅뜲?댄듃?댁빞 ?⑸땲??