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, the regulatory expectation is clear: chemical characterisation is no longer optional. 

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 characterisation services ate Eurofins Medical Device Services  network of laboratories addresses these challenges.  

As an ISO 17025-accredited laboratory network, our characterisation 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 characterisation 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 sterilisation residuals 
• ISO 10993-19: Physico-chemical, morphological and topographical characterisation 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 impurities and degradation products, our expert chemists apply high-resolution analytical methods to characterise what’s present—both intentionally and inadvertently—in your device components. 

Medical device manufacturers partner with trust Eurofins Medical Device Services to: 

• Confirm the purity of their raw materials 
• Characterise 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 programme 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 characterisation, extractables profiling, or validation of changes to sterilisation methods, we will build a testing pathway that fits your timeline and regulatory plan. 

With Eurofins Medical Device Services, your devices are characterised thoroughly and accurately, so that regulators can approve them with confidence, and patients can benefit from them sooner.