All categoriesCategory
Quality & Risk
QMS, risk management, and process controls for medical devices.
36 termsFilter in glossary
Popular quality & risk terms
Corrective and Preventive Action(CAPA)
Systematic process to investigate and resolve quality issues and prevent recurrence.
Design Controls
Structured process governing the design of medical devices.
Medical Device Single Audit Program(MDSAP)
Single audit of a manufacturer's QMS satisfying multiple participating regulators.
Quality Management System Regulation(QMSR)
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
Quality System Regulation(QSR / 21 CFR 820)
FDA's current good manufacturing practice (cGMP) requirements for medical devices.
Risk Management File(RMF)
Set of records and outputs from the ISO 14971 risk management process.
All Quality & Risk terms
- 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