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For a limited time, book a one-hour session to discuss YOUR SPECIFIC product and challenges, and find solutions.

Early product design decisions have
lasting testing consequences

Every year, thousands of medical devices move from concept into manufacturing. Today, the FDA classifies more than 7,000 unique medical device categories, each presenting its own manufacturing, validation, and testing challenges. CTS can help you navigate these testing challenges and set yourself up for success—from the beginning!

It all starts with a simple, no-obligation informal engineering discussion.

Let’s talk through your product, your questions, and the kinds of issues we commonly see before products reach production—and set you up for success!

 

Common Challenges Facing Medical Manufacturers

CTS has helped hundreds of medical device teams work through R&D and test design challenges. With over 40 years’ experience, CTS is a top provider of leak and flow test solutions. We offer a broad portfolio of technology to get our customers the highest levels of quality control within their processes—and have the extensive experience to tackle any challenge.

One of the most common challenges we see in medical manufacturing is that leak and functional testing aren't discussed until a product is nearly ready for production handoff. By then, many of the design decisions that determine how a product will be tested have already been made. The result can be longer validation timelines, more complex fixtures, slower cycle times, and manufacturing teams trying to solve problems that could have been addressed much earlier.

Let’s change that! By recognizing these challenges early, your team can make informed decisions that support a practical, repeatable, and scalable manufacturing test strategy. Book an engineer discussion today to get started!

 

High Precision Testing for Medical Devices

Part of what sets CTS apart is our extensive knowledge of regulations and industry-accepted equipment testing guidelines for medical device testing, including applications, process validation, data collection and storage, calibration, and test specifications. Because every customer is different, we provide reliable medical device leak testers that can be configured based on your exact needs. 

We work confidentially with partners ranging from global corporations to small, specialized startup ventures. Our team has extensive experience in testing equipment and will work with you to develop a medical leak testing solution that is specifically tailored to your unique needs.

Trusted Leak and Blockage Testing for Medical Devices

The trend toward personalized medical care has also driven a demand for precision medical devices. No longer a one-size-fits-most industry, many types of medical devices now come in a wide range of sizes and features, along with complex geometries like as tubes, balloons, bags, and other components that can make testing more challenging. Variables like flexibility and elasticity of common polymer-based disposable medical device materials can have a significant impact test repeatability. 

To address these complexities, medical device leak testers must provide effective sealing and understand how to deliver and measure the pressure with adequate sensitivity to produce accurate test results. Part of this includes selecting the optimum medical leak testing method and equipment. With years of experience in the medical device industry, CTS’s team of application experts will work with you to identify the best leak testing solution for your specific needs. 

Leak Testers, Seals and Turnkey Systems for Medical Device Manufacturing Quality

CTS Sentinel Blackbelt and Blackbelt Pro instruments feature technology that provide greater measurement precision and accuracy—up to 6x more compared to other systems. We also offer  automated, turnkey leak and flow benchtop system for medical devices. When superior sealing is required, particularly for catheters and small valve assemblies, we provide Luer connectors for a durable seal.

Early product design decisions have
lasting testing consequences

Every year, thousands of medical devices move from concept into manufacturing. Today, the FDA classifies more than 7,000 unique medical device categories, each presenting its own manufacturing, validation, and testing challenges. CTS can help you navigate these testing challenges and set yourself up for success—from the beginning!

It all starts with a simple, no-obligation informal engineering discussion.

Let’s talk through your product, your questions, and the kinds of issues we commonly see before products reach production—and set you up for success!

 

On-demand Webinar: Intro to Leak & Blockage Testing of Medical Devices

Learn the fundamentals of leak testing and the most common methods used for medical devices.

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To Discuss Your Leak Detection System Requirements

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Contact Cincinnati Test Systems to learn more about our leak detection equipment

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