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Medical device stamping on servo presses requires a higher level of process control and documentation than typical industrial applications. FDA 21 CFR Part 820 and ISO 13485 requirements drive specific practices.
## Why Servo Press for Medical Devices
Medical device components ??surgical instrument blanks, implant components, catheter fittings ??require:
- Dimensional tolerances of ?0.01-0.05mm
- 100% traceability of process parameters
- Validated and locked processes (no unauthorized changes)
- Statistical process control (SPC) data
Servo presses provide advantages over mechanical presses for these requirements:
- Programmable motion profiles allow precise control of forming speed and dwell
- Tonnage monitoring provides 100% in-process inspection
- Data logging capability for traceability
- Repeatable process from lot to lot
## Process Validation Requirements
Under IQ/OQ/PQ validation protocol:
**Installation Qualification (IQ):**
- Verify press specifications match purchase order
- Confirm calibration certificates for tonnage monitor and position encoder
- Document software version and parameter settings
**Operational Qualification (OQ):**
- Run press at 3 speed settings (min, nominal, max)
- Verify tonnage monitor accuracy against load cell reference
- Confirm position repeatability: ?0.01mm over 100 strokes
**Performance Qualification (PQ):**
- Run 3 production lots at nominal conditions
- Measure critical dimensions on 30 parts per lot
- Confirm Cpk ??1.33 for all critical dimensions
## Data Logging Setup
Configure press data logging to capture per-stroke:
- Peak tonnage
- BDC position
- Forming speed at BDC
- Timestamp
Most modern servo presses support CSV export or OPC-UA connection to MES systems.
## Change Control
Any change to press parameters requires re-validation:
- Motion profile changes ??OQ re-run
- Tooling changes ??PQ re-run
- Press relocation ??Full IQ/OQ/PQ