Chemical characterization is no longer a check box exercise. For today’s medical device developers, extractables and leachables (E&L) testing plays a critical role in risk mitigation, regulatory submission, and avoiding costly setbacks later in development. But for many small to mid-sized manufacturers, this stage is riddled with uncertainty. What testing do you really need?

The Eurofins Medical Device Services network of laboratories provides the clarity, speed, and scientific expertise you need to move forward with confidence. Our ISO 17025-accredited facilities, staffed by 100 dedicated E&L scientists, offer more than 30 years of experience and access to more than 500 advanced HPLC and GC systems. 

Important phases in your product development lifecycle that may require E&L assessments include:

• Changing raw material suppliers 
• Developing new product design concepts 
• Implementing design or manufacturing process changes 
• Performing verification testing for your design history file  

From protocol design to toxicological risk assessment, we support you every step of the way. We will work with you to:

• Conduct simulated-use or leachables testing based on real-world exposure 
• Determine the most appropriate test conditions for your device 
• Identify compounds using our proprietary spectral database of more than 1,500 non-volatile substances 
• Perform exhaustive or exaggerated extractables studies (ISO 10993-18) 
• Perform toxicological risk assessments (ISO 10993-17) with reports ready for regulatory submission
• Select the right solvents and extraction methods 

Our coordinated E&L packages, often delivered in parallel with biocompatibility testing, compress timelines and reduce the risk of late-stage issues. With direct access to our expert toxicologists, your project will benefit from real-time troubleshooting, guided decisions, and clear justifications for regulatory authorities.

• Dedicated project manager and expert point of contact 
• One unified workflow for E&L, toxicology, and biocompatibility 
• Risk assessments aligned with FDA guidance and ISO 10993 standards 
• Support during changes to raw materials, suppliers, or manufacturing processes 

Whether you're launching a new product, submitting a 510(k), or responding to a regulatory query, our goal is to help you uncover any potential issues before they become costly complications.

The responsive, reliable, and accessible teams within Eurofins Medical Device Services ensure your E&L project stays on track, on time, and on budget. 

Partner with our experts

Biocompatibility testing

Biological evaluation plans

Method development & validation

Stability for leachables

Toxicological risk assessments