Even small adjustments in design, materials, suppliers, or manufacturing processes can significantly influence how a medical device performs. Shifts in mechanical behavior, durability, flow characteristics, or structural stability can compromise patient safety, delay regulatory clearance, or disrupt market entry. When devices are used in clinical environments, every detail matters. Manufacturers must demonstrate that each component performs safely, consistently, and in line with international standards and guidelines.
Eurofins Medical Device Services provides comprehensive performance testing across a wide range of medical technologies. Based on the specialized expertise of ac.biomed - now part of the Eurofins network - we offer validated methods, custom test development, and deep engineering know-how for devices such as heart valves, stents, cannulas, blood pumps, oxygenators, arterial filters, cardiotomy reservoirs, and vascular prostheses.
Our laboratories are ISO/IEC 17025 accredited and operate under ISO 9001 certified quality systems.
Accelerated wear, calcification, computational flow field assessment, dynamic failure mode, hydrodynamic performance, particle image velocimetry (PIV), steady backflow leakage, steady forward flow, thrombogenicity
Integral water permeability testing, water entry pressure, kink diameter/radius, pressurized burst strength
Blood cell damage, gas exchange performance, heat exchanger performance, pressure drop, integrity
Chronic outward force, radial resistive force
Blood cell damage, integrity testing, kink resistance, pressure drop, recirculation testing
Blood cell damage, air handling capacity, defoaming characteristics
Blood cell damage, air handling capability, filter flow rate, filtration efficiency
Blood cell damage, thrombogenicity, cavitation, hydraulic performance
Blood cell damage, thrombogenicity, cavitation, hydraulic performance
Blood cell damage
Chronic outward force, radia resistive force
Verification of device behavior under physiological and challenging conditions, aligned with the standards relevant to each device type.
Long‑term mechanical endurance and accelerated wear testing.
Testing of flow resistance, pressure gradients, regurgitation, air handling, and blood‑contact behavior.
Mechanical robustness, burst pressure, integrity and failure mode analysis.
Tailored protocols and bespoke test rigs and methods for innovative devices or technologies without established standards - an established strength of ac.biomed’s engineering team.
Comprehensive data packages supporting FDA, EU MDR, and international submissions, aligned with the standards guidelines as listed above.
Eurofins Medical Device Services partners with manufacturers developing Class I, II, and III devices, combination products, and emerging technologies. Our multidisciplinary engineering and scientific teams help reduce development risk, validate design decisions, and build a strong evidence base for global market access. Whether your priority is rapid time‑to‑market or deep technical insight, our performance testing programs support your device from concept to clinical use.
