Who we serve
Infrastructure for the products that demand control.
If your product needs a clean, documented, quality-controlled environment — and a route to market — it belongs on the Levaris Platform.
Don’t see your category? If your product benefits from cleanroom processing and a documented quality system, we’d still like to hear about it.
Tell us about your productOne standard for every product
Built to the standard of human tissue products.
Whatever you make, it runs inside the same facility, quality system and discipline we use for our own HCT/Ps.
Explore the facilityISO 13485
Quality management system aligned with ISO 13485, the medical-device quality standard.
ISO 7 / ISO 8
Classified modular cleanrooms with controlled material and personnel flow.
ISO 5
Biosafety cabinets for aseptic, open-product processing.
21 CFR 1271
Processes designed to meet applicable FDA requirements for HCT/Ps.
Tell us what you’re building.
We’ll respond to schedule a confidential discovery call — or an in-person or virtual tour of the Salt Lake City facility.