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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.
Cardiovascular Devices
CTS offers many testing options for cardiovascular devices, including leak test devices for balloon catheters, multi-lumen catheters, and vascular access sheaths.
Diagnostic Sets
In diagnostic applications, such as microfluidic chips or reagent cartridges, CTS leak testers reliably detect leaks and blockage.
Solution, Drug & Blood Management
CTS has extensive experience in leak testing products used to manage liquids, such as bags, cannula and flow regulation devices, check valves, and tubing sets.
Respiratory Devices
Mass flow testing is often used to address the numerous configurations of respiratory devices, such as breathing circuits, humidification chambers, nasal cannula and more.
Endoscopic Devices
CTS has the expertise to ensure accurate and reliable leak and blockage testing of disposable laparoscopic/endoscopic devices, which require precise testing processes to accommodate complex device structures and multi-seal systems.
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.
Sentinel Blackbelt
The world’s most versatile single-channel pressure decay and mass flow testing instrument. A high-precision benchtop instrument, it provides unmatched flexibility in a proven, standard platform.
Sentinel Blackbelt Pro
Multi-channel leak, flow, pressure, and vacuum instrument available in wall mount and benchtop configurations. 21 CFR Part 11 & EU Annex 11 friendly, it provides up to four individual testing channels with one fully integrated instrument.
Turnkey Leak and Flow Benchtop Test Systems for Medical Devices
Automate your leak testing with a turnkey test solution fully controlled by a Sentinel Blackbelt instrument.
CTS Connect with Luer Connectors
Our CTS Connect product line offers luer-style connection fittings for use in the medical industry and a range of other options to seal parts during test.
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.
Contact CTS
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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