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