 Circle Medical
Devices offers our R&D clients complete manufacturing engineering
services and clinical device manufacturing in an FDA registered
facility. Clean room manufacturing and full service device packaging
available.
- Device History Record Generation
- Device
Specifications
- Manufacturing Process Instructions
- BOMs
- Lot Control &
Traceability
- Material Procurement &
Control
- Purchasing/Sourcing
- Receiving and Inspection
- Inventory Management
- Material & Product Storage
- Process Development &
Validation
- Tooling/Fixture Design & Fabrication
- Equipment IQ/OQ/PQ
- DOE
- Protocols/Testing/Reports
- Sterile Package Design, Process & Testing
- Tray/Pouch Specifications & Design
- Tray/Pouch Sealing
Validation
- Package Integrity Testing/Package Conditioning
- Sterilization
Validation, Management, Protocols
& Reports
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