The challenge of ensuring the biological safety of medical devices is becoming more complex. Whether you’re developing next-generation implants, resorbable polymers, or devices with novel materials, regulatory expectations mean the need for expert chemical characterization is greater than ever. 

But what happens when you encounter unknown compounds during testing? What if you’re unsure which ISO 10993 standards apply, or even when they apply? Uncertainties like these will cost you time, money, and in the worst cases, delay approvals. For manufacturers trying to bring vital treatments to market, such risks are unacceptable. 

The comprehensive chemical characterization services ate Eurofins Medical Device Services network of laboratories addresses these challenges.  

As an ISO 17025-accredited laboratory network, our characterization services are built around ISO 10993 guidelines and are designed to ensure regulatory compliance across global markets. 

• ISO 10993-9: Framework for identification and quantification of potential degradation products 
• ISO 10993-12, 18, 19: Chemical characterization of materials 
• ISO 10993-13, 14, 15: Identification and quantification of degradation products 
• ISO 10993-16: Toxicokinetic study design for degradation products and leachables 
• ISO 10993-17: Establishment of allowable limits for leachable substances 
• ISO 10993-7: Ethylene oxide sterilization residuals 
• ISO 10993-19: Physico-chemical, morphological and topographical characterization of materials 

Our laboratories house more than 500 chromatography systems, allowing us to detect and identify a broad range of substances. From extractables and leachables to degradation products and other impurities, our expert chemists apply highly robust analytical methods to characterize what’s present - both intentionally and inadvertently - in your device components.

Medical device manufacturers trust Eurofins Medical Device Services to: 

• Confirm the purity of their raw materials 
• Characterize degradation and dissolution in resorbable devices 
• Assess safety profiles of processing aids and additives 
• Evaluate the impact of supply chain or manufacturing changes 
• Ensure freedom from contaminants such as machining oils or residual solvents 

Every testing program we design is risk-based and tailored to your device, materials, and intended use. We support you in identifying the right sample strategy, avoiding unnecessary repeats, and streamlining your regulatory submissions. Our scientists also advise on toxicological risk assessments, providing clarity where data gaps exist and strengthening your overall biocompatibility package. 

Whether you’re looking for full material characterization, extractables profiling, or validation of changes to sterilization methods, Eurofins Medical Device Services will build a testing pathway that fits your timeline and regulatory plan. 

Build a confident, compliant characterization strategy.