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Device-grade assembly, compliant to ISO 13485.
PCBA and harness assembly for medical device OEMs, built under documented, traceable process control compliant to ISO 13485.
How We Serve Medical
Medical device manufacturing lives on documentation and traceability — exactly the disciplines SEI built its reputation on. Our processes are compliant to ISO 13485 for medical-device assemblies, with lot-level material traceability, controlled processes, and the configuration management to support regulated submissions. Device OEMs get a partner who treats their DHF-supporting records as seriously as the hardware.
ISO 13485 COMPLIANT
LOT TRACEABILITY
DOCUMENTED PROCESS
- PCBAPrinted circuit board assemblySMT and through-hole to IPC-A-610 / J-STD-001 Class 2 & 3
- CABLECable & wire harnessDiscrete to multi-branch, IPC/WHMA-A-620 Class 2 & 3
- BOX BUILDElectromechanical integrationSmall units to full cabinets, turnkey through drop-ship
- PANELSControl panelsBuild-to-print panel assembly, wired and verified