Taking a Class II medical wearable from prototype to ISO 13485 production
Structuring EVT, DVT and PVT for a regulated product, and building the documentation trail auditors expect.
How we moved a connected sensor product to a new contract manufacturer, with no line-down events and a lower unit cost.
The client’s wireless vibration sensor was selling well, but their original contract manufacturer could not keep up. Lead times had grown to 16 weeks, first-pass yield was under 90%, and each new purchase order came with a price increase. They needed a new manufacturing partner without putting existing customer deliveries at risk.
We started with a two-week audit of the design package, BOM and test process. We found:
Together with the client’s engineering team we qualified alternates for seven of the nine single-sourced parts. For the RF module, where no drop-in alternate existed, we put a last-time-buy plan and buffer stock in place.
We sent a normalized RFQ package to five pre-qualified EMS providers across two regions, audited the two shortlisted sites in person, and negotiated a contract with clear yield, lead-time and price-review terms.
We designed a pogo-pin functional test fixture that covers 94% of nets, wrote the work instructions, and ran a 200-unit pilot build before releasing to volume.
“Apthea Labs gave us a manufacturing team overnight. The transfer was the smoothest one we have ever done.” — VP Engineering
The new line shipped its first volume order 14 weeks after kickoff. There were no gaps in customer deliveries, unit cost dropped by 18%, and first-pass yield settled above 99%.
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