All ecosystems
Ecosystem
Manufacturing & Supply
Process validation, design transfer, contract manufacturers, sterilization, UDI, and the supply-chain controls that keep finished devices flowing.
29 terms
Regulatory1
Quality & Risk1
Standards4
Manufacturing22
- Bill of Materials(BOM)
- Bioburden
- Cleanroom Classes (ISO 14644)
- Container Closure Integrity(CCI)
- Counterfeit Parts and Suspect Components
- Design Transfer
- Device History Record(DHR)
- Device Master Record(DMR)
- Endotoxin Testing (LAL)
- Engineering Change Order / Notice(ECO / ECN)
- Lot Traceability
- MRP and ERP Systems(MRP / ERP)
- Pre-Approval Inspection(PAI)
- Process Capability (Cp/Cpk) and SPC
- Process Capability and Cpk
- Process Validation
- Scrap Rate and Yield
- Stability Testing
- Sterilization
- Supplier Controls
- Technology Transfer (Manufacturing)
- UDI-DI vs. UDI-PI