Confirm your device tolerates the EO cycle before formal validation
A feasibility study gives you early data on whether your device, packaging, and chosen sterilization parameters will work together. We design and execute feasibility protocols that cover biocompatibility, shelf-life stability, and transport simulation.
The result: you enter formal validation with real data, not assumptions. That saves time, money, and regulatory headaches later.
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Four reasons device teams begin with feasibility
Fractional cycles confirm feasibility early
Know your process works before committing to full validation. Avoid costly surprises downstream.
Parallel workstreams save months
Run biocompatibility studies while validation is in progress. Parallel work compresses your overall timeline.
No surprises on capacity
We confirm fit upfront so your production plan stays on track.
Regulatory foundation from day one
ISO 13485 certified and FDA registered throughout. Your data is defensible from the start.
Registered and audited for medical device work
ISO 13485 Certified & FDA Registered
Est. No. 1064858
FDA Innovation Challenge 2 Winner
Recognized for responsible innovation
Environmental Stewardship Award
Small Business recipient
NC Permit Exemption
Exceptionally low emissions