OEM ultrasound design & manufacturing
ALEVA is a turnkey OEM partner for ultrasound. As an engineering organization — not an equipment reseller — we take a medical-imaging product from industrial design through acoustics, FPGA beamforming, signal processing, software and production — and our QA team prepares the ISO 13485, FDA 510(k) and CE/MDR technical documentation your company needs to license the product under your own brand.
We are the engineering team behind other companies’ products.Backed, warrantied, and fast
Full-stack engineering
Industrial design, acoustics, FPGA beamformer, signal processing, software and manufacturing — under one roof.
Licensing documentation
Our QA team prepares the ISO 13485, FDA 510(k) and CE/MDR technical documentation your company needs to license the product — a major advantage for our partners.
Fast, professional service
Handled in the minimum time possible, with rush options for urgent cases.
24-hour response
We answer every inquiry within 24 hours.
Last updated: July 2026. Discuss your project with our engineering team.
What we build for you
- Industrial & mechanical design — enclosure, ergonomics, and probe housing.
- Acoustics & transducer design — array/stack design, matching layers, lens and backing for your target frequency and application.
- FPGA beamformer boards — parallel receive processing, designed, built and supplied for your systems.
- Signal & image processing — front-end to image-chain engineering.
- Embedded software & applications — control, imaging modes and interfaces.
- Manufacturing & production — electronics and probe manufacturing, from pilot runs to volume.
Regulatory documentation for licensing
The slowest part of bringing a medical-imaging product to market is usually regulatory approval. If your company asks us to develop an ultrasound device under your own brand, we take on the full technical build — housing and mechanical design, tooling and molds, electronic boards, and software — and, over the course of the project, our QA team prepares the technical documentation aligned with ISO 13485 (quality management), FDA 510(k) (US clearance) and CE marking under EU MDR that your company needs to obtain the product's license. You receive a market-ready product and a complete documentation package to license it under your brand — a significant advantage for our partners. (ALEVA already holds FDA and CE for its own products.)
From concept to a licensed product
- Discovery — requirements, target specs (frequency, footprint, application) and regulatory pathway.
- Design & simulation — acoustic, electronic and mechanical design with modeling.
- Prototype & validation — functional prototypes, bench testing and image validation.
- Production & documentation — scaled manufacturing plus the ISO/FDA/CE technical documentation handed to you to support licensing.
Related: read about our FPGA + GPU beamformer, the iProbe probe line, and our manufacturing capability.
Frequently asked questions
Do you offer full OEM ultrasound design and manufacturing?
Yes. ALEVA is a turnkey OEM partner — we handle industrial design, acoustics and transducer design, FPGA beamformer boards, signal processing, software and manufacturing from prototype to volume production.
Do you provide the regulatory documentation (ISO, FDA, CE)?
Yes. When we develop a device under your brand, our QA team prepares the technical documentation aligned with ISO 13485, FDA 510(k) and CE/EU MDR that your company needs to license the product. ALEVA also holds FDA and CE for its own products. Talk to us about the exact regulatory scope for your device.
Can you design a custom ultrasound probe or beamformer?
Yes. We design custom transducers and probes (linear, curved, phased-array, endocavity, 4D/volume, TEE) and FPGA beamformer boards with parallel receive processing, built and supplied for your systems.
How fast can you move from prototype to production?
We move from prototype to production in the minimum time possible and respond to every inquiry within 24 hours. Timelines depend on the device and regulatory pathway.
Have a product in mind?
Tell us about your device, target application and volumes, and we'll scope a design-build-and-document path.