제품
???멸퀎 遺€?묒슜 蹂닿퀬瑜???怨녹뿉?? (Global Safety Monitoring Room.)
誘멸뎅, ?좊읇, ?쒓뎅, ?몄＜... 援??蹂꾨줈 ?ㅻⅨ 蹂닿퀬 ?묒떇 ?뚮Ц??怨좏넻諛쏆? 留덉꽭?? 遺덈쭔(Complaint)????踰덈쭔 ?낅젰?섎㈃, 媛곴뎅 洹쒖젣 湲곌???留욌뒗 蹂닿퀬??eMDR, MIR)媛€ ?먮룞?쇰줈 ?앹꽦?⑸땲??
Decision Tree
"??遺덈쭔??蹂닿퀬 ?€?곸씤媛€??" 蹂듭옟??寃곗젙 濡쒖쭅???댁옣?섏뿬, ?대떦?먭? 洹쒖젣 蹂닿퀬 ?щ?(Reportability)瑜??ㅼ닔 ?놁씠 ?먮떒?섎룄濡??뺤뒿?덈떎.
Gateway Submission
?앹꽦??蹂닿퀬?쒕? FDA ESG 寃뚯씠?몄썾?대굹 EUDAMED濡?吏곸젒 ?꾩넚(Direct Submission)?⑸땲??
Recall Manager
由ъ퐳 諛쒖깮 ?? ???멸퀎 吏€?ъ뿉 ?뚯닔 紐낅졊???섎떖?섍퀬 吏꾪뻾?⑥쓣 ?ㅼ떆媛꾩쑝濡?吏묎퀎?섎뒗 ?€?쒕낫?쒕? ?쒓났?⑸땲??
자주 묻는 질문
Q. 蹂닿퀬 ?щ? 寃곗씠?곗? ?곕룞?섎굹??
A. ?꾨땲?? 理쒖쥌 寃곗젙?€ ?щ엺???댁빞 ?⑸땲?? ?? ?쒖뒪?쒖? 寃곗젙???꾩슂??吏덈Ц("?щ쭩?낅땲源?", "?щ컻 媛€?μ꽦???덉뒿?덇퉴?")???섏졇???먮떒???뺤뒿?덈떎.
Q. ?앹빟泥?蹂닿퀬???먮룞?쇰줈 ?섎굹??
A. ?? ?섎즺湲곌린 ?꾩옄誘쇱썝李쎄뎄 蹂닿퀬 ?묒떇怨??명솚?섎뒗 ?뚯씪???앹꽦??以띾땲??
Q. 留덉빟瑜????섏빟??蹂닿퀬???섎굹??
A. 蹂??쒖뒪?쒖? **?섎즺湲곌린(Medical Device)** ?꾩슜?낅땲?? ?섏빟??紐⑤뱢?€ 蹂꾨룄 臾몄쓽 諛붾엻?덈떎.