Moving an industrial IoT sensor to a new EMS partner in 14 weeks
How we moved a connected sensor product to a new contract manufacturer, with no line-down events and a lower unit cost.
Industrial IoT
← All insights
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.
- 3Build phases, all passed on schedule
- 0Major non-conformities at audit
- 6 moPrototype to pilot production
The challenge
A funded medtech start-up had a working wearable prototype and a regulatory submission date. They had no manufacturing partner, no design history file structure and no internal operations staff.
Our approach
We split the programme into three gated build phases:
| Phase | Quantity | Focus |
|---|---|---|
| EVT | 50 | Design verification, DFM feedback |
| DVT | 300 | Reliability, biocompatibility, test validation |
| PVT | 1,000 | Process validation (IQ/OQ/PQ), line capability |
At each gate, the go/no-go decision was based on agreed exit criteria. Yield, test coverage and open CAPA items were all tracked on one shared dashboard.
Choosing a partner that fits a regulated product
We only shortlisted EMS providers with an active ISO 13485 certification and a track record of FDA and MDR audits. We checked traceability down to reel and lot level during the site audits.
Test strategy
Every unit goes through a combined boundary-scan and functional test. The results are logged against the device serial number, so the device history record is generated automatically.
Outcome
The client moved from prototype to pilot production in six months, and passed their notified body audit with no major non-conformities.