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A quality system built for audits
ISO 13485:2016 certified and FDA registered, with records designed to be read by your auditors, not just filed.
ISO 13485:2016
Certified quality management system covering machining, molding, assembly, packaging, and engineering.
FDA Registered
Registered establishment operating under FDA quality system requirements for device manufacturers.
ISO Class 7
Cleanroom classified to ISO 14644-1 with continuous particle and pressure monitoring.
Traceability
Electronic device history records linking every lot to material certs, operators, and equipment.
How quality is built in
Four Steps Between Your Drawing and a Released Lot.
Risk first
Process FMEAs drive what we validate and how hard we test it, so protocols stay focused on what can actually go wrong.
Validate
IQ, OQ, and PQ on every production process, with statistical sampling plans justified in writing.
Monitor
SPC on critical dimensions, cavity pressure monitoring on molding, and seal strength testing on packaging lots.
Release
Lots are released against a reviewed device history record, and the record ships with the product.
Inspection
Measured With the Right Tool for the Feature.
- Optical and video measuring systems
- Contact CMM with sub-micron probing
- Surface roughness and form testing
- Seal strength, dye penetration, and bubble testing
- Functional test fixtures built per program
Starting a new program?
Bring Us In Before the Design Freezes. It Costs Less for Everyone.
A tolerance that adds a secondary operation or a material that needs a new supplier is easy to change on paper and expensive to change after verification testing.
How our NPI process worksGet a free design for manufacturability review on your next device.
- Written findings within five business days
- Cost drivers ranked by impact
- No obligation to build with us
Talk to a Program Manager(763) 555-0148