Blood pump testing with proven precision
As cardiovascular innovation intensifies, so too does the pressure to deliver safe, reliable blood pump technologies. While you are tasked with balancing complex performance requirements, stringent regulatory expectations, and accelerated development timelines, you also have to prioritise patient safety. Even minor inconsistencies in flow dynamics or haemocompatibility can have critical consequences, making robust validation not just necessary, but essential.
The Eurofins Medical Device Services network of laboratories supports manufacturers facing these challenges with comprehensive, high-precision testing solutions. From early-stage development through to regulatory submission, we provide the data and insights you need to move forward with confidence.
Our capabilities combine advanced simulation environments with deep scientific expertise to evaluate key performance characteristics. We assess flow dynamics to ensure consistent and efficient circulation, along with detailed haemocompatibility testing to help identify potential risks related to blood interaction. In parallel, thrombogenicity studies enable early detection of clotting risks, and cavitation analysis ensures device durability and long-term reliability under real-world conditions.
Each study is designed with regulatory compliance in mind. Our teams apply established methodologies alongside customised protocols to align with global expectations, helping you avoid delays and reduce the risk of costly redesigns. With access to state-of-the-art facilities and specialised equipment, we generate robust, reproducible data that withstands regulatory scrutiny.
Beyond testing, we act as a strategic partner. Our scientists and project managers work closely with your teams to streamline processes, optimise study design, and accelerate timelines. This integrated approach enables you to progress efficiently from validation to approval, without compromising on quality.
By working with the Eurofins MDS network of laboratories, you gain more than technical capability. You gain a partner with the expertise, infrastructure, and regulatory understanding required to support the successful development of life-sustaining blood pump devices, helping you bring critical innovations to market with certainty.
Blood pump testing methods that support compliance
Assessing blood cell damage is a critical challenge in the development of blood-contacting medical devices. Mechanical stress can lead to haemolysis, increasing the risk of anaemia, organ strain, and further complications for patients. At the same time, manufacturers must generate reliable data to meet stringent regulatory expectations and demonstrate device safety.
The Eurofins Medical Device Services (MDS) network of laboratories delivers precise haemolysis testing, in accordance with ASTM F1841, ISO 18242, and ISO 14708-5. We evaluate red blood cell damage under controlled, physiologically relevant conditions, ensuring accurate and reproducible results.
Our advanced testing systems and analytical expertise provide detailed insights into device performance, supporting optimisation of design elements such as flow dynamics and material surfaces. With clear, compliant reporting, we can streamline regulatory submissions and accelerate time to market.
By partnering with Eurofins MDS, you will be confident that your blood-contacting devices meet global safety standards while maintaining optimal performance.
Cavitation testing
Cavitation presents a critical challenge in the development of blood pumps. Uncontrolled bubble formation and collapse can damage components, reduce efficiency, and cause haemolysis, placing patient safety at risk. Demonstrating reliable performance under real-world conditions is essential, yet identifying cavitation onset and its impact can be complex and time-consuming.
The Eurofins Medical Device Services network of laboratories delivers cavitation testing in accordance with ISO 18242, ensuring robust, standardised evaluation. We replicate physiological flow and pressure conditions tailored to your device requirements, enabling accurate detection of cavitation onset and bubble behaviour. Using advanced instrumentation, including high-resolution flow visualisation and sensor-based bubble counting, we generate precise, actionable data.
Our testing verifies safe operating ranges, supports regulatory submissions, and helps optimise device design. With expert analysis and clear reporting, we enable early identification of risks, reducing costly redesigns and accelerating development timelines.
Thrombogenicity testing
Thrombosis remains one of the most critical risks in blood pump development. Clot formation within or around a device can disrupt flow, impair performance, and lead to severe complications such as embolism or stroke. Demonstrating control over thrombogenicity is essential, however replicating realistic conditions and generating meaningful data can be challenging.
The Eurofins Medical Device Services network of laboratories delivers specialised thrombogenicity testing designed for blood pumps. We simulate physiological flow rates, shear stresses, and pressure conditions to replicate clinical use with accuracy.
Our approach combines quantitative measurement of activated clotting time (ACT) with optical analysis of clot formation, providing clear insight into thrombogenic potential. These data enable targeted design optimisation, supporting improvements in impeller geometry, surface properties, and flow paths.
With advanced test systems and expert analysis, Eurofins MDS provides robust, compliant data to support regulatory submissions and accelerate development timelines.
Hydraulic performance testing
Achieving reliable hydraulic performance is a fundamental challenge in blood pump development. Inconsistent flow or pressure can compromise perfusion, while poor hydraulic design may contribute to haemolysis or thrombosis. Manufacturers must generate robust, clinically relevant data to demonstrate both safety and performance under a wide range of operating conditions.
The Eurofins Medical Device Services network of laboratories provides hydraulic performance testing in full compliance with ISO 18242. We evaluate flow and pressure characteristics across clinically relevant ranges, ensuring precise measurement of pump output and behaviour.
Our capabilities include assessing operational stability under variable preload and afterload conditions, replicating real-world patient scenarios. With advanced instrumentation and expert analysis, we deliver accurate, reproducible data to support design optimisation, from impeller geometry to control systems.
Comprehensive, compliant reporting supports global regulatory submissions, helping to speed up approval timelines. By partnering with us, you gain confidence that your blood pumps deliver consistent, safe, and effective performance.