In medical devices, dimensional stability and material integrity aren’t optional—they’re regulatory requirements. If forming or plating distorts thin parts, or tolerance drift causes leaks, seizure, or bad readings, compliance is at risk and launches stall.
Gromax designs, builds, stamps, and inspects under one roof, keeping every step traceable and verified. Our DFM, tooling, stamping, and gaging teams work together so parts stay stable through forming, plating, sterilization, and assembly—precision you can validate and prove to any auditor.
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PPAP/FAI, lot-level certs, GR&R ≤10% on CTQs, and controlled special processes tied to part numbers.
Materials/finishes proven for EtO, gamma, and autoclave (passivation, electropolish, Ni/Pd-Ni/Au, Sn) without drift or discoloration.
±0.0015″ features, tight true-position, and ≤0.10 mm coplanarity; coined flats and downset control for shields and leadframes.
BeCu/bronze springs with tuned normal force, selective Au/Pd-Ni on wipe, and burr direction managed away from mating.
Carriers engineered for insert/overmold transfer, pick-and-place features, in-reel orientation, and clean break tabs to cut scrap.
Glove handling, low-lint packs, RoHS-compliant chemistries, surface roughness control, and plating microsections for release.
Small, tight-tolerance parts used in connectors, clips, brackets, shields, springs, and cartridge assemblies are strong fits—especially when the design depends on repeatable geometry, burr control, and stable fit in molded housings.
We focus on CTQs tied to actual device performance, not just print dimensions. That includes gaging to functional datums, monitoring tool wear, and controlling burrs, springback, and formed features over long runs.
Key items are housing stack-up, edge condition, spring-force consistency, cosmetic surfaces, and inspection repeatability. These often drive device performance more than a single dimension on the print.
Look for repeatable process control, traceability, documented inspection, burr and cosmetic control, and experience supporting high-spec parts used in regulated devices.
Depending on the program, support can include FAI or FAIR, inspection reports, SPC, PPAP when required, and MSA or Gage R&R.
Yes. Supplier transitions are often a good fit when a program needs tool transfer, repair, requalification, and tighter control without risking fit, function, or inspection consistency.
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