Medical devices · Levaris Platform
Cleanroom manufacturing for medical devices — inside a quality system built for them.
ISO 13485 is the quality standard for medical devices, and our quality management system is aligned with it. Pair that with ISO 7 and ISO 8 cleanroom space and an experienced team, and device companies can move into controlled production without building their own.
What your product needs
How the platform delivers for medical devices.
| Your requirement | What the platform provides |
|---|---|
| Clean assembly and packaging | 2,600 ft² of modular ISO 7 / ISO 8 cleanroom space. |
| Quality system | A quality management system aligned with ISO 13485. |
| Environmental control | Continuous environmental monitoring and contamination-control practices. |
| Development support | R&D and QC lab space for development and testing support. |
| Market access | Sales, authorized distribution and customer-support teams. |
Products we support
Built for programs like yours.
Every program starts with a technical and quality assessment, so we confirm fit before you commit.
- Biologic-based and combination products
- Wound-care and dressing products
- Single-use devices that require cleanroom assembly
The facility
5,200 ft² in Salt Lake City, under one quality system.
ISO 7 and ISO 8 cleanrooms, ISO 5 processing, QC and R&D labs, and production-scale lyophilization — with research, quality and manufacturing under one roof.
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.
Your path onto the platform
Which describes your company?
Other industries
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.