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Tag: medical-devices
9 items with this tag.
Apr 25, 2026
ISO 14971 (Medical Device Risk Management)
standard
iso
risk-management
medical-devices
regulated
Apr 25, 2026
Design Controls
capability
design-controls
medical-devices
regulated
Apr 25, 2026
Design History File (DHF)
data-object
dhf
medical-devices
regulated
Apr 25, 2026
Device History Record (DHR)
data-object
dhr
medical-devices
as-built
regulated
Apr 25, 2026
Device Master Record (DMR)
data-object
dmr
medical-devices
regulated
Apr 25, 2026
21 CFR Part 820 (FDA Quality System Regulation)
standard
fda
qms
medical-devices
regulated
Apr 25, 2026
ISO 13485 (Medical Device QMS)
standard
iso
qms
medical-devices
regulated
Apr 25, 2026
EU MDR (Regulation 2017/745)
standard
regulation
eu
medical-devices
regulated
Apr 25, 2026
UDI
data-object
medical-devices
traceability
regulatory