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Customer Case Study
Custom Gaging & Inspection
A medical OEM passed FDA validation with in-line gaging that kept production moving.
The Problem
A medical device OEM was preparing for FDA submission on a new patient monitoring unit. The parts had tight tolerances on slots, bends, and contact points, and the FDA required full dimensional validation during IQ/OQ/PQ.
The challenge? Their existing inspection setup was too slow and inconsistent. Operators were waiting on CMM checks that took hours, and quality engineers worried about missed features slipping through. They needed a repeatable, FDA-ready inspection method that didn’t choke production.
The Solution
We built inspection into the process itself.
1) Designed and manufactured custom functional gages that simulated the part’s actual fit in the device assembly.
2) Built Go/No-Go fixtures for critical slots and contact points so operators could confirm dimensions in seconds, not hours.
3) Designed dedicated CMM holding fixtures to speed up repeatable measurements when deeper checks were needed.
With these gages in place, inspection became fast, consistent, and traceable — exactly what regulatory auditors want to see.
The Results
The customer passed FDA validation on schedule. Production ran smoothly with in-line checks that operators could handle themselves, and CMM bottlenecks disappeared. Most importantly, their quality engineers had full confidence in the data during submission.
Instead of inspection being the weak link, it became one of their biggest strengths.
Why It Matters
In regulated industries like medical, aerospace, and defense, inspection isn’t optional — it’s the gatekeeper. That’s why Gromax designs custom gaging and fixtures that keep quality locked in at the press, not just in the lab.