Bioexcel supports medical device manufacturers with toxicological and biocompatibility documentation aligned with ISO 10993 biological evaluation and EU MDR expectations.
We help translate chemical characterization and material information into clear, regulator-ready toxicological justifications that support technical documentation and clinical evaluation.
What We Deliver (Capabilities)
Core Toxicology Capabilities (Medical Devices)
- ISO 10993 Biological Evaluation Support
- Biological evaluation planning and documentation alignment to device contact type and duration
- Toxicological Risk Assessment (TRA)
- Toxicological evaluation of identified substances from chemical characterization and materials
- Chemical Characterization Interpretation
- Support to interpret ISO 10993-18 outputs and present regulator-ready conclusions
- Extractables & Leachables (E&L) Interpretation (Medical Devices)
- Toxicological interpretation of extractables/leachables and risk justification in device context
- Evaluation support for polymers, additives, residues, and processing-related substances
- Material & Process Toxicology Support
- Evaluation support for polymers, additives, residues, and processing-related substances
- EU MDR Technical Documentation Support
- Integration of toxicology outputs into technical documentation and risk management
Services
Frequently Asked Questions (FAQ)
ANSWER – ISO 10993 biological evaluation is applied based on
device contact type and duration. The evaluation approach is justified through a biological evaluation plan.
Answer-Bioexcel supports planning, interpretation, and
documentation. Testing is performed by qualified laboratories; we support selecting appropriate tests and
presenting results.
ANSWER – A TRA evaluates the toxicological
risk of substances identified from materials and chemical characterization, supporting safety justification.
ANSWER – Yes. Toxicology and biocompatibility documentation forms part of the technical documentation and supports NB review.
