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Capability 02

Ultrasound transducer OEM & medical manufacturing

ALEVA designs and manufactures custom ultrasound probes with nominal center frequencies up to 30 MHz, tailored to customer requirements. Discuss an ultrasound transducer OEM manufacturing scope covering the agreed probe assembly, medical-electronics integration and production-transfer activities. Define the build stage, responsible production site and acceptance evidence before agreeing quantities and delivery.

A manufacturing partner for the companies that build medical devices.

A device is only as good as the day it’s built. We build like it matters — because it does.

ALEVA and iProbe medical-device manufacturing facility exterior
Manufacturing services

From board to finished probe

Define what you need supplied: an acoustic assembly, a cabled and housed probe, or an agreed electronics-and-probe integration scope. Match the quotation to that deliverable, including its design revision, inspection requirements and handover records.

01

Contract manufacturing

Build-to-print and full-service manufacturing for medical devices and imaging hardware, scaled to your program.

02

Medical electronics assembly

PCB assembly and system integration to medical-grade standards, with process control and documentation.

03

Ultrasound probe manufacturing

Transducer and probe assembly — acoustic stacks, cabling and housings built for consistent imaging performance.

04

Quality control & testing

Structured inspection and functional testing at every stage, so only conforming product moves forward.

05

Calibration

Calibration of probes and imaging hardware to keep measurement accuracy and image quality within specification.

06

Supply chain management

Sourcing, component management and logistics — a managed, resilient supply chain behind every build.

Quality & standards

Building toward ISO 13485 compliant production

Quality is engineered into the process, not inspected in at the end. As ALEVA scales, its manufacturing is being developed toward ISO 13485 compliant medical-device production — with the documentation, traceability and process discipline that healthcare partners require.

  • Traceability by design

    Materials, processes and test results tracked through every build.

  • Test & calibration built in

    Functional testing and calibration are part of the line, not an afterthought.

  • Roadmap to certification

    Processes structured now to support formal ISO 13485 compliance as we grow.

iProbe ultrasound probe production line inside a cleanroom

Need a manufacturing partner?

Share your non-confidential assembly scope, design status, prototype or pilot quantity, and expected repeat-order needs. Include your target schedule and required test records so the manufacturing discussion can focus on a defined build.

Define the project

What an ultrasound transducer OEM manufacturing scope should define

Requirements

Separate the acoustic stack, assembled probe and finished imaging device in the quotation. Identify the responsible engineering team and production site, the controlled design revision and the activities assigned to each party. Define the intended host, connector, operating conditions and agreed build stage before comparing price or delivery proposals.

Verification evidence

Use an acceptance record that connects a result to the unit and configuration tested. Our proposed record fields are: unit or lot identifier; hardware revision; host and software revision; test-method revision; fixture and instrument identifiers; calibration status; operating conditions; acceptance limits; measured results; and review disposition. This is a proposed record structure, not a completed ALEVA test report.

For acoustic-field measurements, identify the hydrophone calibration and measurement uncertainty. NPL's public calibration documentation explains frequency-dependent hydrophone sensitivity and traceability; those measurement details belong alongside the reported result. NPL calibration reference

Deliverables and handover

Agree the released drawings, assembly instructions, fixture ownership, test procedures and change-notification process for the next build. Define what happens when a unit does not meet a criterion, including review and retest responsibilities. Record which evidence supports prototype acceptance and which additional evidence is needed for pilot or repeat production.

Discuss a manufacturing scope · Explore pre-production probe engineering

For pre-production engineering, explore custom ultrasound probe design through iProbe. Before selecting a manufacturing route, use the ultrasound transducer OEM manufacturer qualification checklist to compare scope and evidence.

Share non-confidential requirements through our project contact page to discuss the agreed scope.

OEM transducer manufacturing questions

Does a probe design agreement also define production supply?

Not automatically. Define prototype, pilot and repeat-production responsibilities separately, including the manufacturing site, design records, acceptance tests and change control.

Which manufacturing evidence should an OEM request?

Request the proposed test plan, acceptance criteria, calibration and traceability records, revision control and handling of nonconforming units. Verify any certificate against its named entity, site, scope and validity.

What production volumes and lead times are available?

Quantities, minimum orders, lead times and capacity are project-specific. Agree these in the quotation together with tooling, documentation, supply-continuity and warranty responsibilities.