Testing Services
Knowing what needs to be tested, how long it will take, and just what the regulatory requirements are for each type of device demands special expertise.
Work With Us to Navigate Devices
Expert Support to Hit Timelines and Overcome Hurdles
Developing a medical device is never straightforward. Whether you’re a start-up or a global manufacturer, you need to navigate complex regulations, competing priorities, limited prototypes or sample quantities, and ambitious timelines.
That’s why so many developers rely on Eurofins Medical Device Services network of laboratories. Our global reach and scientific depth make us the preferred partner on the path from concept to commercialisation.
Whatever stage of development your device is at, Eurofins Medical Device Services is equipped to support you intelligently, reliably, and on time.
Services
Whether you’re developing a Class I, Class II, or Class III device, Eurofins Medical Device Services verifies and validates your product designs, confirms biocompatibility and efficacy, and ensures regulatory readiness.
Consulting Services
Whether you’re preparing for your first submission or managing post-marketing surveillance, you need a partner who can anticipate challenges, bridge knowledge gaps, and keep your product moving safely, swiftly, and successfully through every phase of its lifecycle.
Our consulting teams bring years of hands-on experience across device classifications, helping manufacturers align with regional and international requirements without losing momentum.
Sterile Packaging Services
With packaging being the final barrier protecting the sterility, integrity, and performance of your medical device, nothing can be left to chance.
It’s vital to understand the challenges of regulatory compliance, cost control, and maintaining patient safety – particularly when sterile barrier systems must be customised for novel technologies. Equipped to support you at every stage of the sterile packaging process, our scientists work closely with your teams to deliver fully compliant packaging systems, optimised for both performance and cost-efficiency.
Dedicated Project Management
You’ll be assigned a single project manager – your dedicated point of contact – who understands your device, development stage, and regulatory expectations.
They’ll coordinate all aspects of device development across our global network, keep you updated, and ensure your strategy aligns with regulatory requirements throughout your device’s lifecycle to meet every milestone.
Comprehensive, Flexible Support
From biological evaluation planning to packaging validation, our services span the full spectrum of medical device services:
- ISO 10993 biological evaluation and biocompatibility testing
- Material characterisation and stability studies
- Sterilisation and reprocessing validations
- Microbiology, toxicology, and shelf-life testing
- Package integrity and transportation simulations
Our methods are scalable, our scheduling responsive, and our experts always on hand to advise on next steps.
Real-Time Insight
You can track your project progress online 24/7 with our secure LabAccess.comSM portal. It enables you to access raw data, analyst notebooks, approved results, certificates, and invoices, providing the transparency and control needed to stay informed and in front.