All ecosystems
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.
99 terms
Regulatory15
- AI Act Post-Market Monitoring
- AI Act Serious Incident Reporting
- AI Act Technical Documentation (Annex IV)
- Benefit-Risk Determination
- Class III Device
- De Novo Classification Request(De Novo)
- Fundamental Rights Impact Assessment(FRIA)
- High-Risk AI System (EU AI Act)
- IVDR Risk Classes A–D
- Notified Body Scrutiny (IVDR Class D)
- Premarket Approval(PMA)
- Provider and Deployer (EU AI Act)
- Summary of Safety and Clinical Performance(SSCP)
- Systemic Risk (GPAI)
- Technical Documentation
Quality & Risk39
- 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 Analysis
- 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(QMS)
- Quality Management System Regulation(QMSR)
- Quality Manual
- Quality System Regulation(QSR / 21 CFR 820)
- Risk Acceptability Matrix
- Risk Management
- 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
Cybersecurity6
Clinical & Trials3
Standards25
- ASTM F2503
- Essential Performance
- Harmonised Standards
- ICH E6(R3) Good Clinical Practice(E6(R3))
- IEC 60601-1
- IEC 60601-1-2
- IEC 60825
- IEC 62304
- IEC 62366-1
- IEC 82304-1
- ISO 10993-1
- ISO 11135
- ISO 11137
- ISO 11607-1/-2
- ISO 13485
- ISO 14155
- ISO 14971
- ISO 15223-1 Symbols
- ISO 17511
- ISO 17665
- ISO 20417
- ISO 22301
- ISO/IEC 23894
- ISO/TR 24971
- Usability Engineering