USON - Verdict Medical Devices
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Leak Testing Equipment and Medical Device Leak Testing Systems

8640 N. Eldridge Parkway,
Houston, TX 77041,
United States of America

8640 N. Eldridge Parkway,
Houston, TX 77041,
United States of America

USON leak testing equipment is used around the world by manufacturers of all kinds of medical devices, medical equipment and medical supplies that have specifications for leak rates – catheters, drug-eluting stents, laparoscopic surgical instruments, medical check valves, ocular surgical kits, wound care supplies, sealed device packaging and more.

Leak testing of medical devices and medical device components

When quality and patient safety require reliable leak testing of medical device components, sub-assemblies and/or fully assembled medical devices, equipment and technology, leading medical device manufacturers look to USON and its deep bench of leak testing applications engineering expertise.

USON leak testing equipment has cradle-to-grave support, from validation to re-configuration for testing new device designs. Always ‘on-call’, USON has designed more medical device leak test solutions than any other company in the world.

A detailed no-cost evaluation of best-match leak testing equipment for your medical device requirements will typically be returned to you within 48 hours by USON’s leak testing applications engineers. Similarly, a detailed proposal for semi- or fully-automated leak test assemblies will typically be returned to you within two weeks, or sooner. At your request, and also at no charge, video conference consultations are also available to discuss your leak test challenges.

Leak and flow tester for medical devices

The unique Optima vT multi-sensor design can leak test two parts with four chambers needing different leak test or other test specifications or simultaneously test one medical device with eight compartments that need to function differently. If you want to do sequential multiple leak or other tests on each part with a throughput of more than a million parts per year this is the world’s best-match leak detector.

Optima vT was designed to not only handle leak and flow testing of the medical device designs you have today; it can be easily re-configured for medical device designs of the future.

Features that make Optima vT so versatile include: a highly intuitive and large easy-to-read operating display built both for operators and engineers programming leak test and other test sequences; ability to do any combination of flow tests, pressure decay leak tests, differential pressure decay, vacuum leak tests, occlusion or burst and cracking pressure tests, force decay leak tests and more (combining for over a half billion possible permutations on test sequences); totally customizable pneumatic configurations; built-in automated calculators; and multiple options for data handing and data storage.

Leak detector for small-volume medical device production

Sprint IQ is the leak detector used and validated for FDA compliance by the greatest number of medical device manufacturers in the world. Sprint IQ is the ideal leak tester for small-volume medical device component leak testing at the fastest throughputs. It has up to 13 different leak test modes – pressure decay, mass flow, vacuum, occlusion / burst, etc. – with the capability to run up to four tests concurrently.

Leak tester for high-volume medical device production lines

The Vector leak tester has up to ten independent leak test channels (up to two sensors, i.e. 20 independent leak tests) making it the best-in-class leak detector for high-volume medical device production lines. Any medical device that requires multiple types tests performed asynchronously – up to 20 leak and flow test types in any combination – can harness Vector, the world’s leak testing equipment ‘powerhouse’. Windows®-based, extensive I/O programming, easy integration into automated assemblies and more – Vector is designed for leak testing any size part, or for medical devices in high volumes.

Leak testing equipment for medium-volume leak testing

Qualitek MR leak testing equipment features USON’s proprietary and most sensitive differential pressure decay sensor and a wide array of other leak tests to select from, up to 32 I/O step programming, easy integration into automated assemblies, ready-to-use pneumatics and electronics. This is the best match leak detector for medium volume (up to 4l) single channel leak testing.

Non-destructive leak testing

Flexible packaging of medical devices can be non-destructively tested under vacuum for leaks with real-time monitoring during production with Qualipak, unique leak testing equipment that totally eliminates human error or requirements for highly trained operators needed for other types of package leak testers.

Semi-automated and fully automated medical device leak testing

USON Innovative Systems (UIS) provides world-class turnkey solutions for semi-automated and fully automated medical device leak testing.

UIS delivers accelerated time-to-market with a validation-centered approach, industry-leading engineering talent with a concentration on solving leak testing challenges, efficient automated systems with high reliability USON leak testers, and elimination of risks inherent with less sophisticated systems or lower quality leak testing equipment.

Leak Testing Considerations for Medical Devices

Automatic leak detection is now a common occurrence and part of the quality control process for many companies. There is a wide choice of equipment available and techniques from which to choose.

The Relationship Between Pressure Decay and Leak Rate

Most pressure decay panels measure pressure changes in mbar, Pascal, mbar/sec or Pascal/sec. This presents a challenge because leak specifications are usually specified in volumetric units such as cc/sec or cc/min.

Customized RFID Tags Introduced by Uson to Speed Throughput of Medical Device Leak Testing

Global medical device manufacturers seeking the highest standards of lean manufacturing for leak-proof medical devices by using RFID tags for parts identification and information tracking can now use a unique electronic label system built by Uson with both standard and custom components tailored to application requirements. The custom elements of Uson RFID tags streamline parts processing and help manage test data while cutting overall production cost.

Uson Launches New Turnkey Service for Medical Device Leak Testing Automation and Validation

Global medical device manufacturers seeking to eliminate the risk of releasing defective products to market that do not adhere to the device's leak rate specifications can now rely on Uson-Innovative Systems (UIS), a newly created joint venture between Uson's best-in-class leak testers and Innovative Products and Equipment's automation systems expertise.

Uson Announces Demonstrations of Maths-Powered Leak Test Optimisation for Medical Device Industry

Manufacturers of medical devices requiring leak testing, who are seeking continuous quality improvements and/or faster leak test cycle times while maintaining Gage R and R, can now schedule customised videoconference demonstrations of the of mathematical functions built into USON's recently-unveiled Optima vT leak and flow tester. These one-on-one no-cost video consultations will include application-specific demonstration of how Optima's built-in mathematical tools could improve yields and quality.

Uson Announces Appointment of Charles D Foran Jr as Company President

Uson, pioneer of automated leak detection equipment for the automotive, industrial, medical device and packaging industries, announces the appointment of an award-winning veteran of the automated instrumentation industry, Charles D Foran Jr (Dave), as USON President.

Uson Announces Medical Device and Biotech Pressure Decay Leak Testing Automated Calculator

Medical device and biotechnology product manufacturers can now obtain the USON Pressure Decay Leak Test Calculator-- the first in a family of automated Uson NDT test calculators - to generate nearly instantaneous answers to 'What If' modeling of pressure decay leak testing variables and exact returns-on-investment from new eight-sensor concurrent leak testing technology

Uson Announces Videoconferencing for Custom Leak Detection Systems for Medical Device Development

Medical device design, manufacturing and quality engineers seeking best match leak test solutions can now rely on Uson's no-cost videoconferencing consultations to facilitate discussions and visual inspection of leak-proof medical device components and products for which the appropriate leak detection equipment, fixturing and all other leak test specifications are required.


8640 N. Eldridge Parkway

Houston, TX 77041

United States of America

Uson UK – Europe

Western Way

Bury St Edmunds

Suffolk, IP33 3SP

United Kingdom

Detroit Office

31471 Utica Rd

Fraser, MI 48026

United States of America

Uson China

Room 1701 Suncome Liauw’s Plaza

No. 738 Shangcheng Road

Pudong, Shanghai 200120