for Market-Ready Devices
Mechanical testing assesses how materials perform under pressure and physical stress. For teams without in-house expertise or facilities, the challenge of meeting stringent mechanical testing requirements can feel overwhelming. Then there’s the potential of missed deadlines due to component failures or product redesigns, lack of regulatory knowledge and/or increasing costs.
Eurofins Medical Device Services network of laboratories has advanced facilities, deep technical expertise, and a portfolio of mechanical testing services to help device developers overcome complexity and get to market with confidence. We perform testing across a broad range of components and finished devices to ensure device strength, durability, and safety under real-world use conditions. By applying these tests – such as hardness, fatigue, and impact testing – our engineers can identify weaknesses in components that could lead to structural failure.
Services:
We work in accordance with ISO 11608, ISO 11040, ISO 80369, USP 788, and other regulatory standards to ensure your testing programme aligns with FDA and international expectations. Whether you’re preparing for 510(k) submission or pre-market approval (PMA), our specialists guide you through every step with rapid turnaround times (typically 1–2 weeks) and flexible scheduling.