Quality Control
Quality held to medical standards
Because a wearable touches skin around the clock, every unit passes a multi-gate quality system with 100% functional testing.
Quality control
Quality gates at every stage
01
Incoming (IQC)
Components inspected and verified on arrival.
02
In-process (IPQC)
AOI and checks at each assembly step.
03
Functional test
100% of units tested for sensors, battery and BLE.
04
Reliability (ORT)
Ongoing drop, life and waterproof sampling.
05
Outgoing (OQC)
Final audit before shipment release.
Standards
Certified, audited, traceable
Our quality management system is held to medical-device standards, with full traceability from raw material to finished unit.
- ISO 9001 & ISO 13485 QMS
- 100% functional testing
- Full lot traceability
- Third-party audit support
- RoHS / REACH material control
Certifications
Compliance you can rely on
ISO 9001
ISO 13485
CE
FCC
RoHS
REACH
BQB
IP68
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