Medical Device Class II Diagnostic Device — Sensor Board Requalification
A Class II diagnostic device maker requalified a failing sensor board line without slipping a regulatory-locked launch date.
- Layers
- 8
- Volume
- 18,000 units/year
A Tier-1 automotive supplier moved a body control module from a low-volume prototype vendor to production-scale supply under IATF 16949.
A Tier-1 automotive supplier had validated a body control module design with a prototype-focused vendor but had no path to the automotive-qualified production volume — the vendor's line wasn't IATF 16949 certified and couldn't support the supplier's PPAP documentation requirements for a 240,000 unit/year program.
Copperline's automotive-certified line took over the program starting from PPAP submission, running the existing 6-layer design through DFM review to confirm manufacturability at volume before committing tooling. Process controls, traceability, and defect-rate reporting were structured to IATF 16949 requirements from the first production lot, not retrofitted after a pilot run.
The program passed PPAP on the first submission and has run in continuous production for two full model years, currently at 240,000 units/year with defect rates tracked and reported against the supplier's automotive quality scorecard every quarter.
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Medical Device A Class II diagnostic device maker requalified a failing sensor board line without slipping a regulatory-locked launch date.
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