Biocompatibility and Toxicology Evaluation of Medical Devices and Combination Products

Biocompatibility Evaluation includes a large variety of services to advise you on the tests necessary to ensure the safety and efficiency of your medical device or combination product.

Our team of experts has the expertise necessary to help you address challenges that may arise with Biocompatibility Testing and Toxicological Risk Assessment. They can offer insights and direction for challenging in vitro/in vivo biocompatibility tests and/or chemical characterisation test results.

Our team of experienced toxicologists is adept at identifying potential issues pertaining to your device and helping to provide strategies to address these prior to regulatory submission. We can scale consulting services to meet each device, whether it is a single project, or regular ongoing support.

We can first create a Biological Evaluation Plan (BEP) based on ISO 10993-1:2018 to detail the strategy that has to be used to address biological risk or biocompatibility at any stage of development. More precisely, the BEP examines:

• Configuration
• Material composition
• Manufacturing
• Intended use
• Testing information and the clinical history
• Potential biocompatibility gaps

A Biological Evaluation Report is then written to summarise all the data and new tests made to fill the potential biocompatibility gaps.

Our expert team can then perform:

• Biological risk assessment according to ISO 10993-1
• Chemical characterisation plan (incl. AET) according to ISO 10993-18
• Toxicological risk assessment according to ISO 10993-17
• Risk assessment of carcinogenic, mutagenic and reprotoxic chemicals (CMR) and endocrine disruptors
• Biological safety of gas pathway devices according to ISO 18562.

Choose Eurofins Medical Device Consulting to help you:

• Leverage our knowledge of biocompatibility through our global network of laboratories.
• Analyse your device’s test results to identify any gaps or concerns.
• Reduce risk through early identification of potential issues.
• Develop strategies to address identified challenges.
• Provide supporting documents for submission to regulators.

Beyond those services, we also offer regulatory support, literature review of the constituents, validity of studies, risk plan review and advice, expert recommendations, test summary reports, and management of unexpected data.