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.

Populated circuit board from a medical diagnostic device, showing precision SMT assembly
Industry
Medical Device
Layer Count
8
Production Volume
18,000 units/year

Challenge

A Class II diagnostic device manufacturer was six weeks from a regulatory-locked launch date when their existing sensor board vendor's yield dropped below 80% on an 8-layer board with tight impedance-controlled traces. Every day spent requalifying threatened the launch window, and any design change risked reopening part of the regulatory submission.

Approach

Copperline's applications team reviewed the existing Gerbers and impedance stack-up without requesting a redesign, identifying a lamination-sequence mismatch between the specified core/prepreg pairing and the vendor's actual production stack as the likely yield driver. A corrected stack-up was proposed that held the same electrical characteristics and required no changes to the submitted design files, then validated with a small pilot panel before committing to full volume.

Outcome

Pilot yield came back above 96%, and full production ramped in time to hold the original launch date. The board now runs at 18,000 units/year with IPC-A-610 Class 3 acceptance criteria and full AOI/X-ray documentation retained per lot, per the manufacturer's quality system requirements.

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