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Tag: regulated
15 items with this tag.
Apr 25, 2026
Risk Management
process
risk-management
regulated
Apr 25, 2026
Corrective and Preventive Action (CAPA)
data-object
capa
quality
regulated
Apr 25, 2026
Risk Matrix
data-object
risk
fmea
regulated
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
Quality Management System (QMS)
capability
qms
quality
regulated
Apr 25, 2026
21 CFR Part 11 (Electronic Records and Signatures)
standard
fda
electronic-records
signatures
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 IVDR (Regulation 2017/746)
standard
regulation
eu
ivd
regulated
Apr 25, 2026
EU MDR (Regulation 2017/745)
standard
regulation
eu
medical-devices
regulated
Apr 25, 2026
Standard Operating Procedure (SOP)
artifact-type
sop
quality
regulated