Advanced oxygenator testing solutions
Patient outcomes rely on the precise performance of life-sustaining devices. Oxygenators are at the heart of extracorporeal circulation systems, where even minor inefficiencies in gas exchange can compromise safety, surgical success, and recovery. With manufacturers facing increasing regulatory scrutiny, compressed development timelines, and constant pressure to demonstrate robust, repeatable performance, navigating these challenges requires more than data. It demands certainty.
The Eurofins Medical Device Services (MDS) network of laboratories supports medical device innovators with comprehensive oxygenator testing designed to reduce risk and speed up development. By combining advanced instrumentation, proven methodologies, and deep scientific expertise, our team helps ensure your devices meet the highest standards of safety and performance ahead of clinical approval.
The approach we’ve developed is built on precision and compliance at every stage. We deliver detailed performance evaluations to assess gas exchange efficiency, pressure drop characteristics, and overall device reliability under clinically relevant conditions. Each study is conducted in accordance with international standards, ensuring your data stands up to regulatory review across global markets.
Through our global network, you’ll gain access to highly trained scientists with extensive experience in cardiovascular and extracorporeal device testing. Our teams will work closely with you to design tailored test protocols that simulate real-world use, helping you identify potential issues early and avoid costly delays later in development.
Our facilities are equipped with cutting-edge analytical technologies, enabling accurate, reproducible results across a wide range of oxygenator designs. From early-stage feasibility through to final validation, Eurofins MDS provides the insight needed to optimise performance and support submission-ready documentation.
With structured project management, clear communication, and regulatory insight, we help streamline your pathway to approval. The result is not just compliance, but the confidence that your oxygenator will perform as intended when it matters most.
By working with the Eurofins MDS network of laboratories, you’ll be teaming up with a trusted ally, one committed to helping you bring safe, effective, life-saving technologies to market with speed and certainty.
Oxygenator testing solutions that reduce risk
In the development of oxygenators, maintaining blood integrity under real-world conditions is critical. Blood cell damage, including haemolysis and platelet activation, can lead to serious clinical risks, impact device performance, and delay regulatory approval. Without robust, standardised testing, demonstrating safety and reliability becomes a significant challenge for manufacturers.
The Eurofins Medical Device Services (MDS) network of laboratories provides comprehensive blood cell damage testing in accordance with ISO 7199 and FDA guidance. Our capabilities include haemolysis assessment through precise quantification of red blood cell destruction, alongside evaluation of free plasma haemoglobin using optical measurement techniques.
Our team simulates clinical use conditions to replicate cardiopulmonary bypass and ECMO environments, ensuring accurate and relevant performance data. Our structured approach delivers clear, compliant regulatory documentation to support global submissions.
By combining advanced analytical systems with proven methodologies, Eurofins MDS will enable you to demonstrate haemocompatibility, optimise device performance, and fast-track your path to market with confidence.
Gas exchange performance testing
Achieving reliable gas exchange is essential to sustaining life during critical procedures. Inconsistent oxygen transfer or inadequate carbon dioxide removal can compromise patient safety, impact clinical outcomes, and delay regulatory approval. As a result, demonstrating consistent performance under realistic conditions has become a key challenge for manufacturers.
The Eurofins Medical Device Services (MDS) network of laboratories delivers gas exchange performance testing in full compliance with ISO 7199 and FDA guidance. Our experts measure oxygen transfer efficiency across a range of blood flow rates, in tandem with precise quantification of carbon dioxide removal to confirm effective respiratory support.
Our testing replicates physiological conditions, including controlled temperature, blood parameters, and gas flow parameters, ensuring clinically relevant and reliable data. We also assess long-term performance stability to evaluate consistency during extended operation.
Supported by comprehensive regulatory documentation, the Eurofins MDS approach enables you to validate device performance, optimise design, and obtain faster access to global markets.
Pressure drop testing
Maintaining stable blood flow is as critical in oxygenator development as achieving effective gas exchange. Excessive pressure drop can place strain on pumps, disrupt perfusion, and increase the risk of haemolysis or clot formation. Proving controlled hydraulic performance under realistic conditions is essential to ensuring patient safety and regulatory compliance.
The Eurofins Medical Device Services (MDS) network of laboratories delivers pressure drop testing in compliance with ISO 7199 and FDA standards. We quantify hydraulic resistance across oxygenators at varying blood flow rates, providing precise insight into device performance.
Our testing is conducted under physiologically relevant conditions, including controlled haemoglobin, viscosity, and temperature, to replicate clinical use. Our team also assesses performance stability over extended operation to confirm long-term reliability.
Supported by comprehensive regulatory documentation, the Eurofins MDS approach enables you to validate hydraulic performance, optimise device design, and get to market with increased speed and confidence.
Heat exchanger performance testing
In cardiopulmonary bypass and extracorporeal life support, maintaining precise blood temperature is crucial. Inconsistent thermal control can lead to hypothermia, arrhythmia, or tissue damage, placing patient safety at risk and creating challenges for device approval. Manufacturers need to be able to demonstrate both thermal efficiency and regulatory compliance without delaying time to market.
The Eurofins Medical Device Services (MDS) network of laboratories provides comprehensive heat exchanger performance testing to ISO 7199 and FDA standards.
Our team can evaluate thermal transfer efficiency across a range of flow conditions, ensuring accurate heat exchange performance. Temperature stability assessments confirm consistent operation over extended periods, while pressure drop analysis verifies stable circulation within the device.
The clinical testing methods our experts use simulate real-world surgical environments, generating meaningful, application-relevant data. In addition, our detailed regulatory documentation supports FDA, CE, and global submissions.
By combining advanced instrumentation with expert analysis, Eurofins MDS helps optimise design, ensure compliance, and support safe, effective oxygenator performance.