| CAPA | Corrective and Preventive Action | Systematic process to investigate and resolve quality issues and prevent recurrence. |
| DHF | Design History File | Compilation of records describing the design history of a finished device. |
| FMEA | Failure Mode and Effects Analysis | Bottom-up technique for systematically identifying potential failures and their effects. |
| FTA | Fault Tree Analysis | Top-down deductive analysis tracing how faults can combine to cause an undesired event. |
| MDSAP | Medical Device Single Audit Program | Single audit of a manufacturer's QMS satisfying multiple participating regulators. |
| NCR | Nonconformance (NCR) | Failure of a product, process, or system to meet specified requirements. |
| PFMEA / DFMEA | Process FMEA vs Design FMEA | Two FMEA flavors: DFMEA analyzes design failure modes; PFMEA analyzes manufacturing process failure modes. |
| QMS | Quality Management System | The organizational structure, processes, and resources a manufacturer implements to consistently design, manufacture, and support devices meeting regulatory and quality requirements. |
| QMSR | Quality Management System Regulation | FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. |
| QSR / 21 CFR 820 | Quality System Regulation | FDA's current good manufacturing practice (cGMP) requirements for medical devices. |
| RMF | Risk Management File | Set of records and outputs from the ISO 14971 risk management process. |
| URRA | Use-Related Risk Analysis | Analysis of use scenarios to identify potential use errors and their consequences. |
| V&V | Verification & Validation | Confirming design outputs meet inputs (V) and that devices meet user needs (V). |
| VMP | Validation Master Plan | Top-level document describing the manufacturer's overall approach to qualification and validation activities. |