Medical Device Assembly Solution

## Compliance is the first constraint The biggest difference from ordinary assembly: compliance outranks cycle time. Equipment must support IQ/OQ/PQ validation, electronic batch records and audit trails. We frame the validation documentation during design, not after the machine is built — back-filling documents often takes longer than building the machine. ## Typical configuration - Cleanroom assembly stations (Class 7/8) - 100% vision/force-position monitoring on critical steps - Electronic batch records with MES traceability - Medical-grade materials on contact parts ## State the cycle-time trade-off To achieve 100% critical-step traceability, per-unit cycle runs 15–25% slower than comparable industrial assembly, because every step is captured and recorded. That's the price of compliance; whether it's worth it depends on regulatory class — usually mandatory for Class III, relaxable for Class I. ## Don't underestimate validation From equipment arrival to PQ sign-off often takes 2–4 months. We advise customers to build that into the launch plan rather than discovering it after installation. Named references available on request. ## Technical Specifications | Item | Range | |---|---| | Capacity | 30-600 ppm depending on device | | Environment | ISO Class 7/8 cleanroom compatible | | Processes | Ultrasonic/laser welding, gluing+UV cure, leak test | | Compliance | ISO 13485 QMS, IQ/OQ/PQ validation, 21 CFR Part 11 | | Traceability | Unit-level UDI marking and data capture | ## Typical Line Configuration Vibratory/tray feeding, precision assembly stations, ultrasonic welder, dispensing + UV cure, leak/function test, UDI laser marking, vision QC. ## Case Study A syringe manufacturer validated a 300 ppm assembly line with 100% leak testing and unit-level UDI in 5 months from PO to PQ. ## FAQ **Q: Which cleanroom class do assembly machines require?** A: Most disposable device assembly runs in ISO Class 7 or 8. Machines use low-particle actuators, stainless frames and FDA-compliant contact materials. **Q: What validation support is included?** A: URS review, DQ, FAT with your protocols, and on-site IQ/OQ support; PQ is run jointly with your quality team. **Q: Can the line capture data for UDI compliance?** A: Yes - laser marking plus vision verification, with unit records exported to your MES/UDI database.