Glossary

Adverse Event ReportingThe FDA classifies adverse events not by type but rather by seriousness.

AuditSystematic, independent, and documented process for obtaining evidence and evaluating it objectively

Audit TrailElectronic record showing the chronological sequence of data-related activities.

BenchmarkingBenchmarking involves both evaluating metrics and best practices from other organizations.

BiocompatibilityAssessment of medical device compatibility with biological systems without adverse reactions

CEMarking Symbol indicating conformity with EU regulations for medical devices

Clinical EvaluationCollection and analysis of clinical data to demonstrate safety and performance

Clinical InvestigationStudies involving human subjects to evaluate medical device safety and efficacy

Clinical TrialsStudies to evaluate medical device safety and efficacy in humans before marketing approval

Complaint HandlingProcess for managing complaints related to medical devices

ComplianceAdherence to regulatory standards in medical device manufacturing and distribution

Connected WorkersPeople, systems, and processes truly connected across design, development, quality, safety, and customer lifecycles

Corrective and Preventive Actions (CAPA)Corrective actions are steps taken to address and rectify identified problems, errors, or deficiencies within an organization.

Design ControlManagement of the medical device design and development process

Design DossierIn medical devices, a design dossier is a comprehensive collection of documents that capture the entire design and development process of a specific Class III medical device.

Design Input/OutputRequirements and results of the design and development process

Design ReviewFormal assessment of design and development activities

Design Verification/ValidationConfirmation that design outputs meet inputs and that the device meets user needs

Device ClassificationCategorization of medical devices based on risk

Device History Record (DHR)Documentation of manufacturing processes for each device unit

Device Master Record (DMR)Documents defining device design, manufacturing, and quality requirements.

Digital SOP for Medical DevicesA Digital SOP, or Standard Operating Procedure, is a set of step-by-step instructions presented in an electronic format.

Document ControlProcedures for managing documents related to medical devices

Essential RequirementsFundamental safety and performance requirements for medical devices

EU IVDRIn vitro diagnostics (IVD) and the In Vitro Diagnostic Regulation (IVDR) represent distinct regulatory frameworks for medical devices.

European Medical Device Regulation (MDR)EU regulations for medical device manufacture and distribution

Failure Mode and Effects Analysis (FMEA)Identification and analysis of potential failure modes in products and processes

FDA (Food and Drug Administration)US agency regulating medical device safety and effectiveness.

FDA Warning LetterFDA Form 483 is a document issued by the U.S. Food and Drug Administration (FDA)

Good Manufacturing Practice (GMP)Standards for medical device manufacture ensuring safety and effectiveness

Hazard AnalysisProcess of identifying and evaluating potential device-related hazards

Human Factors EngineeringDiscipline focused on optimizing human-device interaction

In Vitro Diagnostic (IVD)Devices for tests on biological samples

Innovation ManagementProcess of managing ideas and inventions for new product development and improvement

ISO 13485International standard for medical device quality management systems

Just-In-Time (JIT) ManufacturingInventory strategy companies use to boost efficiency and reduce waste by receiving goods only when needed in the production process, which helps lower inventory costs.

Key Performance Indicators (KPIs)Quantifiable measures used to evaluate the success of an organization, employee, etc., in meeting objectives for performance

Labeling RequirementsRegulations for content and format of medical device labels

Lean ManufacturingA systematic method for waste minimization within a manufacturing system without sacrificing productivity

Management ResponsibilityRoles of top management in quality system effectiveness

Medical Device Regulation (MDR)EU rules for medical device manufacture and sale

Non-Conforming ProductProducts not meeting specified quality criteria

Notified BodyOrganization assessing medical device conformity with regulations

Operational ExcellenceOperational Excellence is a part of organizational leadership that stresses applying various principles, systems, and tools to improve key performance metrics sustainably

Post-Market Surveillance (PMS)Monitoring of medical device performance after-market release

Pre-Market Approval (PMA)FDA process for evaluating medical device safety and effectiveness before marketing

Product Lifecycle ManagementManagement of the entire lifecycle of a product from inception, through engineering design and manufacture, to service and disposal of manufactured products

Product RiskProactive approach to tackling all product-related risks

Project ManagementThe discipline of initiating, planning, executing, controlling, and closing the work of a team to achieve specific goals and meet specific success criteria

Quality AssuranceActivities to ensure devices meet quality requirements

Quality Management System (QMS)Framework for consistent product quality and regulatory compliance

Quality PolicyOrganization's commitment to quality and compliance

Regulatory AffairsDepartment ensuring device regulatory compliance

Risk Management Identifying and mitigating device-related risks

Risk-Benefit AnalysisEvaluating the potential risks and benefits of a medical device

Software as a Medical Device (SaMD)Software serving a medical purpose without being part of the hardware

SterilizationProcess to eliminate microbial contamination on medical devices

Supplier ManagementProcess for evaluating and monitoring device component suppliers

Technical FileDocumentation on device design, manufacturing, and performance

TraceabilityAbility to trace a device's history, use, and location

Training and DevelopmentOrganizational activity aimed at enhancing the skills, knowledge, and competencies of an individual or group

Unique Device Identification (UDI)System for tracking medical devices

Usability TestingEvaluating device ease of use with representative users

ValidationEstablishing evidence that a process or system meets requirements

VerificationConfirming that a product meets its specifications

Work InstructionA detailed breakdown of instructions required to carry out one or more steps or tasks in a procedure

X-efficiencyThe efficiency with which a company uses its resources to produce a product compared to the theoretical minimum amount of resources needed for production.

Yield ManagementA strategy related to quality QMS in the shop floor.

Zero DefectsA quality management philosophy that aims for no defects in the manufacturing process and emphasizes the responsibility of all employees to prevent defects.