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Recruiter's Glossary
Industry
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DHR
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Package Validation
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Steam Sterilization
Medical Device Manufacturing Terms
Understanding these terms will help you better evaluate candidates and communicate with hiring managers
Design Controls
Design FMEA
PMA
Quality Assurance
CER
Notified Body
Non-Conformance
UDI
Biocompatibility
ISO Class 7
FDA 21 CFR Part 820
Validation Protocol
ISO 14971
ISO 13485
Risk Management
Stability Testing
Post-Market Surveillance
IVDR
DMR
USP Class VI
Design Verification
DHR
Process FMEA
CE Marking
Sterilization Validation
Clean Room
ISO 10993
Package Validation
Technical File
Shelf Life Studies
Batch Release
DHF
510(k)
Steam Sterilization
GMP
ISO Class 8
European Pharmacopoeia
Particle Testing
IQ/OQ/PQ
Medical Grade Materials
Process Validation
FMEA
MDR
Environmental Monitoring
QMS
EO Sterilization
GUDID
CAPA
Design Validation
EUDAMED
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