Hitec Kev Kho Mob MDR kev cob qhia - Cov ntaub ntawv qhia txog kev xav tau raws li MDR (Part 1)
| Cov ntsiab lus | Cov ntsiab lus |
| Cov lus piav qhia ntawm lub cuab yeej, suav nrog software thiab accessories | Cov lus piav qhia dav dav ntawm cov khoom, suav nrog kev npaj siv thiab cov neeg siv xav tau;UDI;indications thiab contraindications;cov lus qhia rau kev siv;cov neeg siv khoom xav tau;kev faib khoom;daim ntawv teev qauv;cov ntaub ntawv piav qhia;thiab ntsuas kev ua tau zoo. |
| Cov ntaub ntawv muab los ntawm cov chaw tsim khoom | Cov ntawv sau rau ntawm cov khoom thiab lawv cov ntim, cov lus qhia rau kev siv.(Siv hom lus pom zoo rau Lub Xeev Cov Tswv Cuab qhov twg lub cuab yeej npaj rau kev muag) |
| Tsim thiab tsim cov ntaub ntawv | Ua kom tiav cov ntaub ntawv thiab cov lus qhia tshwj xeeb rau kev nkag siab txog theem tsim ntawm lub cuab yeej, cov txheej txheem tsim khoom thiab nws qhov kev siv tau, kev soj ntsuam tas li thiab kev sim khoom zaum kawg. Txheeb xyuas qhov chaw uas tsim thiab tsim cov haujlwm yuav tshwm sim, suav nrog cov neeg ua haujlwm subcontractors. |
| General Safety Performance Requirements GSPR | Cov ntaub ntawv ua qauv qhia txog kev nyab xeeb thiab kev ua tau zoo nyob rau hauv Daim Ntawv Ntxiv I;suav nrog kev ncaj ncees, kev lees paub thiab kev txheeb xyuas cov kev daws teeb meem tau txais los ua kom tau raws li qhov yuav tsum tau ua. |
| Risk-benefit tsom xam thiab kev tswj kev pheej hmoo | Cov txiaj ntsig kev soj ntsuam kev pheej hmoo thiab kev tswj hwm kev pheej hmoo tau suav nrog hauv Daim Ntawv Ntxiv I. |
| Product Validation thiab Verification | Yuav tsum muaj cov txiaj ntsig thiab kev tshuaj xyuas tseem ceeb ntawm txhua qhov kev kuaj xyuas thiab kev lees paub / kev tshawb fawb tau ua |
Cov ntawv sau npe raws li MDR
Post lub sij hawm: Dec-29-2023