All MedTech Terms
513 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.
Showing 1–24 of 39
Biocompatibility
Ability of a material to perform with an appropriate host response in a specific application.
CAPA Effectiveness Check
Verification step confirming a corrective or preventive action actually fixed the problem.
Change Control
Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance.
Complaint Handling
Process for receiving, evaluating, and responding to device complaints.
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.
Design History File(DHF)
Compilation of records describing the design history of a finished device.
Document Control
Procedures ensuring approved, current documents are used and obsolete copies removed.
Failure Mode and Effects Analysis(FMEA)
Bottom-up technique for systematically identifying potential failures and their effects.
Fault Tree Analysis(FTA)
Top-down deductive analysis tracing how faults can combine to cause an undesired event.
FDA Form 483
Notice of inspectional observations issued at the conclusion of an FDA inspection.
Hazard Analysis
The systematic identification of hazards, foreseeable sequences of events, and resulting hazardous situations that underpins a device's ISO 14971 risk management process.
Hazard, Hazardous Situation, and Harm
ISO 14971 distinction underpinning all medical-device risk analysis.
Internal Audit
Planned, independent evaluation of QMS conformity and effectiveness.
IQ / OQ / PQ
Installation, Operational, and Performance Qualification - the three stages of equipment and process qualification.
ISO 31000
Generic enterprise risk management standard; complements ISO 14971's product risk focus.
Management Representative
Member of management appointed to ensure QMS processes are established and report on QMS performance.
Management Review
Top-management evaluation of QMS performance at planned intervals.
Medical Device Single Audit Program(MDSAP)
Single audit of a manufacturer's QMS satisfying multiple participating regulators.
Nonconformance (NCR)(NCR)
Failure of a product, process, or system to meet specified requirements.
Post-Production Information (Risk)
ISO 14971 requirement to feed real-world post-market data back into the risk management process.
Process FMEA vs Design FMEA(PFMEA / DFMEA)
Two FMEA flavors: DFMEA analyzes design failure modes; PFMEA analyzes manufacturing process failure modes.
Production and Process Controls
21 CFR 820.70 / ISO 13485 §7.5 requirements that production processes be planned, controlled, monitored, and validated where needed.
Quality Management System(QMS)
The organizational structure, processes, and resources a manufacturer implements to consistently design, manufacture, and support devices meeting regulatory and quality requirements.