Built for the QMSR era.
The FDA's Quality Management System Regulation raised the bar for supplier controls and outsourced processes. We built for that bar from the start — because in a regulated device, the paperwork is part of the product.
ISO 13485-aligned quality system · IPC-A-610 workmanship standards · RoHS-compliant, lead-free processes · Designed and built in Silicon Valley, USA
Quality system
Quality processes and documentation aligned to ISO 13485 and structured for FDA QMSR expectations — device history records, process validation, and controlled change management.
Standards support
IEC 60601-family compliance support for medical electrical equipment, engineered into the design phase rather than bolted on before submission.
Traceability
Unit-level serialization and full genealogy — from component lot and reel to the shipped device — with labeling and records built for audit.
Inspection stack
AOI, X-ray, functional test, calibration, and automated burn-in on every build, with documented workflows and retained records.
Failure analysis
In-house semiconductor-grade test and FA lab. Root cause happens on site, in days — not in a queue overseas.
Supply chain
Supplier sourcing, BOM optimization, and incoming controls managed from Milpitas — with the supply-chain proximity that reshoring is supposed to deliver.
Audit us.
Bring your quality team to the floor. We'd rather be audited early than discovered late.