Risk Management
Safety by Design.
ISO 14971 is more than a checklist. We engineer your **Risk Management File (RMF)** from Hazard Analysis to Residual Risk Evaluation, ensuring safety is built into the device DNA.
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??
Frequently Asked Questions
FMEA留??덉쑝硫??섎굹??
No. FMEA is just a tool. You must have Hazard Analysis and Benefit-Risk Analysis.
?뚰봽?몄썾???꾪뿕 愿由щ룄 ?ы븿?섎굹??
Yes, inclusive of IEC 62304 Software Safety Classification and controls.
?몄젣 ?낅뜲?댄듃?댁빞 ?섎굹??
Whenever designs change or new post-market adverse events are discovered.