Manufacturing and Industrial
Software for Medical Equipment Manufacturing
Device manufacturing with serial traceability, quality documentation and post-market service records.
Medical device manufacturing combines regulated quality documentation with serial-level traceability that continues after the device leaves the factory. Devices carry service and calibration histories, and any quality issue must be traceable to the components and processes that produced it.
What gets in the way
- Serial-level traceability must extend from components through to the installed device
- Quality documentation is required at defined production stages
- Post-market service and calibration histories must be retained per device
- Component sourcing changes need controlled evaluation
- Field complaints must be traceable back to production records
What the software handles
- Serial assignment with component genealogy
- Stage-wise quality checks with documented results
- Device dispatch record linked to customer and installation
- Service, calibration and complaint history against the serial
- Component change control with evaluation records
What changes
- Complaint investigation traced to production records
- Installed-device service history retained centrally
- Component changes controlled rather than informal
Software for your medical equipment manufacturing business
Start from a ready product or have one built around how you work.