Kev Tswj Xyuas Kev Ua Raws Cai & Scope Boundary
Lub hauv paus ntsiab lus:
Kev tswj hwm kev siv tau yog cov khoom lag luam- tshwj xeeb (mapped ntawm GMDN/UMDNS cov lej), tsis yog daim pam- tau ntawv pov thawj.
Manufacturing Assurance:
Ua haujlwm raws li ISO 13485: 2016 certified QMS.
RA/QA Transparency:
Rov qab los ntawm kev ncaj qha engineering / kev tswj cov ntaub ntawv tshuaj xyuas kom tshem tawm ua ntej - qhov sib txawv ntawm kev ua raws li kev tsim khoom.
Quality Management System (QMS) & Audit Readiness
Lub hauv paus: Cov ntaub ntawv ISO 13485:2016 core nrog traceable CAPA thiab tus neeg muag khoom tswj loops.
Cov neeg yuav khoom tsim nyog pob muaj:
QMS Certificate & Ceeb Toom Lub Cev / Cov Ntawv Sau Npe Kev Tshawb Fawb
Manufacturing site master file summary & cleanroom/assembly kab specs
Nkag mus rau - mus rau - kev tshuaj xyuas zaum kawg SOPs & calibration cav
CAPA kaw metrics thiab keeb kwm kev ntsuam xyuas cov ntsiab lus
Cov khoom siv -Tshwj xeeb kev tswj hwm & Cov ntaub ntawv Technical
Documentation Dossier Match:
Tshaj Tawm Txog Kev Ua Raws Cai (DoC) txuas rau SKU / qauv tshwj xeeb
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Technical Documentation (TD) / Cov Lus Qhia Tseem Ceeb / General Safety and Performance Requirements (GSPR)
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TS EN ISO / IEC 17025 Cov ntawv tshaj tawm kev lees paub ( biocompatibility, kev ua haujlwm ntawm lub cev, txee - lub neej laus)
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Cov ntaub ntawv kev nyab xeeb / biocompatibility tshaj tawm (ISO 10993 lub moj khaum qhov tsim nyog)
CE & European Market (MDR/IVDR Alignment) Ciam teb
Conformity Route:
Kev soj ntsuam hauv Annex/route classification (piv txwv li, tus kheej- tshaj tawm rau Class I uas tsis muaj kev pheej hmoo vs. NB kev koom tes rau kev ntsuas/sterile Class I lossis Class IIa+).
Kev them nyiaj yug:
GMDN daim ntawv qhia, kev txheeb xyuas cov ntaub ntawv sib txawv, thiab ua ntej -kev ua lag luam kev soj ntsuam / kev ntsuas kev ua tau zoo txhawb nqa rau European cov neeg sawv cev tso cai lossis cov neeg xa khoom.
FDA & US Kev Ua Lag Luam Yuav Tsum Tau
Regulatory Posture: Kev sib txawv ntawm cov chaw tsim khoom lag luam sau npe, cov npe khoom siv, thiab 510 (k) / raug zam.
Tus neeg yuav khoom Review Package:
Cov ntaub ntawv pov thawj ntawm kev tsim npe
UDI (Unique Device Identification) npaj txhij thiab barcode grading qauv
Kev soj ntsuam ua raws li daim ntawv lo tiv thaiv 21 CFR ntu 801
Ntshuam -cov ntaub ntawv npaj tau (cov ntawv xa nyiaj lag luam / cov ntawv ntim khoom sib haum xeeb nrog cov lus piav qhia)
Kev Tshawb Fawb, Kev Ntsuas & Kev Ntsuam Xyuas raws tu qauv
Ua ntej-Production Alignment:Ua ntej txiav batch xaj, peb kaw cia:
- AQL sampling qib (piv txwv li ISO 2859-1 kev tshuaj xyuas dav dav II)
- Cov txheej txheem xeem, cov qauv kev lees paub, thiab thib peb - tog kev xaiv cov txheej txheem
- Functional, dimensional, thiab visual defect classifications (Critical, Major, Minor)
Khoom & Traceability Control (UDI / Ntau-Level)
Traceability Chain:
Raw khoom ntau ➔ Cov kab ntau lawm ua haujlwm / tus neeg ua haujlwm cav ➔ Sib dhos / ntim ntim ➔ Cov khoom tiav UDI / batch barcode.
Custom Requirements:
Serialization lossis UDIcarrier kev koom ua ke tau txhais thiab kos npe -tawm ua ntej tus tswv thawv luam ntawv.
Ua ntej-Kev Tshawb Fawb Kev Lag Luam Kev Lag Luam & Cov Txheej Txheem Ua Haujlwm
Xa Kev Tshawb Nrhiav Kev Tshawb Fawb (Parameters hauv qab no)
24-48h Gap Analysis:Hla - tshawb xyuas GMDN, ISO 13485 qhov sib tw, thiab cov ntawv xeem muaj nyob.
Xauv Kev Ua Raws Cai Kos Npe -off:Txuag daim ntawv kos duab, hom UDI, thiab AQL tus qauv.
Volume Production & Lot Dossier Delivery.
Tau txais Pre-Kev Tshawb Fawb Ua Raws Li Kev Ua Raws Cai
Khoom npe / qauv:
GMDN / Lub Hom Phiaj Siv:
Qhov Chaw Ua Lag Luam / Lub Tebchaws:
Lub Hom Phiaj Txoj Cai (piv txwv li, CE MDR Class I, FDA zam / 510k):
Kev txiav txim kom muaj nuj nqis (MOQ / sim / ntim):
Cov Ntaub Ntawv Yuav Tsum Tau (Tshuaj Xyuas lossis Daim Ntawv Teev Npe Kev Cai Kho Mob):
Yam khoom Specification / kos duab txuas: