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Ecosystem
Quality System
The quality management backbone of every device manufacturer - design controls, CAPA, risk management to ISO 14971, and the move from QSR to QMSR in the United States.
83 terms
Regulatory6
Quality & Risk36
- Biocompatibility
- CAPA Effectiveness Check
- Change Control
- Complaint Handling
- Corrective and Preventive Action(CAPA)
- Design Controls
- Design History File(DHF)
- Document Control
- Failure Mode and Effects Analysis(FMEA)
- Fault Tree Analysis(FTA)
- FDA Form 483
- Hazard, Hazardous Situation, and Harm
- Internal Audit
- IQ / OQ / PQ
- ISO 31000
- Management Representative
- Management Review
- Medical Device Single Audit Program(MDSAP)
- Nonconformance (NCR)(NCR)
- Post-Production Information (Risk)
- Process FMEA vs Design FMEA(PFMEA / DFMEA)
- Production and Process Controls
- Quality Management System Regulation(QMSR)
- Quality Manual
- Quality System Regulation(QSR / 21 CFR 820)
- Risk Acceptability Matrix
- Risk Management File(RMF)
- Servicing (21 CFR 820.200)
- Shelf Life
- Summative vs. Formative Evaluation
- Training Records
- Use Specification
- Use-Related Risk Analysis(URRA)
- Validation Master Plan(VMP)
- Verification & Validation(V&V)
- Warning Letter