All MedTech Terms
513 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.
Showing 1–22 of 22
Bill of Materials(BOM)
Structured list of every component, sub-assembly, and quantity needed to manufacture a device.
Bioburden
Quantification of viable microorganisms on or in a product before sterilization.
Cleanroom Classes (ISO 14644)
ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9).
Container Closure Integrity(CCI)
Demonstration that a sterile package maintains microbial barrier and contents integrity over the labeled shelf life.
Counterfeit Parts and Suspect Components
Risk of unauthorized, fraudulent, or substandard components entering the supply chain.
Design Transfer
Translating design into production specifications.
Device History Record(DHR)
Records demonstrating that a device is manufactured per the DMR.
Device Master Record(DMR)
Compilation of records containing the procedures and specifications for a finished device.
Endotoxin Testing (LAL)
Detection of bacterial endotoxin on devices, typically using Limulus Amebocyte Lysate (LAL) assays.
Engineering Change Order / Notice(ECO / ECN)
Documents that authorize and communicate changes to released designs, BOMs, or manufacturing processes.
Lot Traceability
Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number.
MRP and ERP Systems(MRP / ERP)
Material Requirements Planning and Enterprise Resource Planning systems that orchestrate MedTech production and supply chain.
Pre-Approval Inspection(PAI)
FDA inspection of a manufacturing facility prior to PMA approval.
Process Capability (Cp/Cpk) and SPC
Statistical metrics and methods for monitoring whether a process meets its specifications.
Process Capability and Cpk
Statistical measures (Cp, Cpk, Pp, Ppk) of how well a process output fits within specification limits.
Process Validation
Establishing documented evidence that a process consistently produces conforming output.
Scrap Rate and Yield
Production metrics tracking material loss (scrap) and the proportion of acceptable output (yield).
Stability Testing
Studies that establish how device performance and packaging hold up over time.
Sterilization
Validated process used to render a device free from viable microorganisms.
Supplier Controls
Procedures to ensure purchased products and services conform to requirements.
Technology Transfer (Manufacturing)
Transfer of validated processes and knowledge from development (or one site) to commercial manufacturing.
UDI-DI vs. UDI-PI
Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI.