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The MedTech Collective
Community. Curated.
Glossary of Common Terms
Engineering & Manufacturing
Gategory
Related Terms
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Acceptance Criteria
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Agile Development
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Alpha Testing
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Assay Development
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Automated Manufacturing Systems
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Beta Prototype
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Bill of Materials (BOM)
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Biomaterials
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Brainstorming Session
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Cleanroom
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Component Standardization
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Computer-Aided Design (CAD)
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Contract Design and Manufacturing Organization (CDMO)
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Cost of Goods Sold (COGS)
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Design Controls
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Design Input
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Design Review
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Design Transfer
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Design Verification
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Device History Record (DHR)
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Drop Testing
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End-User Training
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Environmental Conditioning
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Environmental Stress Screening (ESS)
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Failure Modes and Effects Analysis (FMEA)
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Full Lifecycle Management
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Functional Safety
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Gap Analysis
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Hydrophilic Coating for Devices
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ISO 62366 (Medical Devices – Application of Usability Engineering to Medical Devices)
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Industrial Design
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Inspection Plan
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Iterative Prototyping
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Lean Manufacturing
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Lifecycle Management
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Manufacturing Execution System (MES)
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Minimum Viable Product (MVP)
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Multi-Cavity Tooling
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Process Validation
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Product Lifecycle Management
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Production Part Approval Process (PPAP)
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Quarantine Procedures in Manufacturing
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Requirements Management
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Serial Number Tracking
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Supply Chain Management
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Technology Readiness Level (TRL)
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Traceability Matrix
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User Requirements
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Version Control
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Vulnerability Management in Cybersecurity
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Workflow Optimization
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Young's Modulus in Materials Testing
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Additive Manufacturing
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Alpha Prototype
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Application Programming Interface (API)
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Assembly Line Optimization
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Batch Manufacturing
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Beta Testing
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Biodesign Process
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Biophotonics
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CNC Machining
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Cloud Computing
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Compression Testing
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Concept Design
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Contract Manufacturing Organization
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Critical Path Initiative (CPI)
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Design History File (DHF)
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Design Output
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Design Thinking
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Design Validation
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Design for Manufacturability (DFM)
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Device Master Record (DMR)
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End-User Requirements
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Engineering Change Order (ECO)
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Environmental Monitoring in Manufacturing
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Extrusion
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First Article Inspection (FAI)
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Functional Requirements
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Fused Deposition Modeling (FDM) in Prototyping
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Human Factors Engineering (HFE)
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ISO 62366 (Medical Devices – Application of Usability Engineering to Medical Devices)
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ISO 9241-210 (Human-Centered Design for Interactive Systems)
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Injection Molding
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Instrument Calibration
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Kinetic Modeling in Drug Delivery
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Life-Cycle Analysis (LCA)
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Logistics in Device Manufacturing
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Manufacturing Validation
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Mock-Up Prototype
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Out-of-Specification (OOS) Events
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Product Development Plan
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Product Roadmap
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Quantitative Data Analysis
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Radio-opaque Materials
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Scale-Up Manufacturing
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Statistical Process Control (SPC)
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Target Product Profile (TPP)
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Tissue Engineering
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Usability Engineering
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Verification & Validation
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Vertical Integration
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Work-in-Progress Inventory
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Yield Improvement in Manufacturing
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Zero-Defect Manufacturing
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