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.