High-performance stent testing solutions
Designing and manufacturing vascular stents means balancing constant innovation with absolute reliability. Every variable, from radial strength to long-term fatigue, must be proven under realistic conditions. Regulatory expectations continue to evolve, while timelines tighten and scrutiny increases. Any uncertainty during testing can delay approvals, impact patient safety, and compromise confidence in your device.
The Eurofins Medical Device Services (MDS) network of laboratories understands these challenges. We work alongside manufacturers to deliver robust, data-driven testing that supports both compliance and innovation. Our approach is built on precision, consistency, and deep technical expertise, ensuring your stent performs as intended in complex physiological environments.
Our comprehensive stent testing capabilities are designed to evaluate every critical attribute of device performance. Mechanical testing programmes measure radial force, recoil, flexibility, and expansion using simulated physiological conditions. These studies provide the detailed insights required to optimise design and confirm durability under continuous mechanical loading.
Regulatory alignment is embedded into every stage of our process. Testing protocols are structured in accordance with ISO 25539, ISO 10993, ASTM standards, and FDA guidance. This ensures that the data generated is not only accurate, but also ready to support global submissions. By integrating compliance into testing from the outset, we help reduce risk and avoid costly delays.
Our laboratories combine advanced instrumentation with experienced scientific teams who understand both the technical and regulatory landscape. This enables us to generate meaningful, reproducible data that supports decision-making throughout development. Whether refining early-stage designs or preparing for regulatory submission, we provide clarity at every step.
Partnering with Eurofins MDS means placing patient safety at the centre of your development process.
Stent testing procedures you can rely on
Maintaining vessel patency over time requires more than initial deployment success. If chronic outward force is too low, vessels may recoil. If it’s too high, the risk of tissue damage or restenosis increases. Striking this balance impacts both patient outcomes and regulatory confidence. Robust, dependable data is essential to guide safe and effective stent design decisions.
The Eurofins Medical Device Services (MDS) network of laboratories delivers comprehensive chronic outward force testing in line with ASTM F3067, ISO 255392, and FDA guidance. We quantify radial forces under controlled conditions, supported by physiological simulations that reflect real-world vessel interaction. Our teams evaluate stent geometry, material composition, and surface treatments to determine their effect on sustained performance.
Through structured methodologies and clear reporting, we enable confident regulatory submissions and informed product development. Working with the Eurofins MDS network of laboratories ensures you gain precise insight to refine designs, support compliance, and protect patient safety over the long term.
Radial resistive force testing
In vascular stents, insufficient radial resistive force (RRF) can lead to vessel collapse, while excessive force risks damaging surrounding tissue. These performance uncertainties can impact patient safety, delay regulatory approval, and limit confidence in device design. Clear, accurate RRF data is essential to move forward with conviction.
The Eurofins Medical Device Services (MDS) network of laboratories provides comprehensive radial resistive force testing aligned with ASTM F3067, ISO 255392, and FDA expectations. Our scientists run precise radial compression testing under controlled conditions, alongside physiological simulations that replicate in vivo vessel behaviour. They also assess material properties, stent geometry, and surface treatments to understand their influence on performance.
Through robust methodologies and detailed reporting, Eurofins MDS supports regulatory submissions and design optimisation, giving you the insights to enhance device reliability, accelerate market access, and safeguard patient outcomes.