DESIGN VERIFICATION TESTING
DESIGN VALIDATION TESTING
MDD
MDR
IQ/OQ/PQ
ISO 13485
CFR 21
DFM
DFA
DHF
FDA
CE MARKING
TECHNICAL FILE
GMP
GCP
DESIGN INPUT ANALYSIS
DESIGN OUTPUT ANALYSIS
GSPR
GPSR
RTM
PSUR
PRAS
DRAS
RMR
RMP
PMCF
PMS
CER
BIO COMP
DCP
DOC
Usability Specification
Usability Engineering Report
Restricted Substances Report
WI/SOPs