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Medical & lab devices

Medical and lab device engineering that passes test the first time.

Mechanical design, test fixtures and verification builds for medical device and lab equipment companies in New Jersey, New York and across the US, from engineers who learned design controls at Stryker.

3D printed oxygen mask prototypes, medical device engineering
What we build

Hardware for labs and clinical teams.

Lab instrumentsCentrifuges, shakers, baths and benchtop devices with motion, heat or fluid handling.
Test fixturesCustom fixtures and rigs for verification, reliability and production testing.
Enclosures & mechanismsHousings, latches and moving assemblies designed for molding, machining or sheet metal.
Verification buildsPrototype units built and tested in our lab, with protocols and reports.
Documentation

Paperwork your quality team can use.

Every phase ends with documents structured to drop into your design history file. We support your regulatory team; we do not replace it.

  • 01Requirements and risk list traced to design features
  • 02Drawings with GD&T, tolerance stack-ups and BOM
  • 03Test protocols and reports from our lab builds
  • 04DFM reviews and a production handoff package
A typical engagement

Phases with a cap on each.

POC · FeasibilitySpec check, architecture, bench tests, go/no-go.
EVT · DesignFull CAD, first engineering units, design review.
DVT · VerificationTest protocols, reliability runs, revisions.
PVT · HandoffDFM-final CAD, documentation, contract manufacturer.
Questions

Before you reach out.

Do you sign NDAs?

Yes. Check the NDA box on the estimate form and we sign before reading anything confidential.

Do you handle FDA submissions?

No. We provide the engineering, testing and documentation your regulatory team or consultant needs.

Can you build units for testing?

Yes. Engineering and verification units are built and tested in our Kearny lab.

What does a project usually cost?

It depends on the device and the phase. Your free estimate gives a range per phase within 3 business days.

Tell us about your device.

Get an estimateBook a call