Brandwood CKC’s biocompatibility experts bring decades of experience in biological evaluation of medical devices and are directly involved as accredited experts to ISO in the preparation of the ISO 10993 biocompatibility standards (as well as ISO 22442 series on biological origin materials and ISO 18562 biocompatibility of respiratory gas pathways). Through their long standing and active participation they are on the cutting edge of new revisions to the standard, as well as understanding what it will take for companies to comply with these requirements globally.
Success in biocompatibility involves not only understanding the science of the requirements, but how these are interpreted by different regulators. We have extensive experience of regulatory application of biocompatibility. This includes direct negotiations with regulators in North America, Europe and Asia Pacific around testing strategies and use of risk assessments to minimise testing burden and speed up evaluations.
Our experts can support:
- biocompatibility strategy including pre-submission consultations with regulators,
- testing plans (including design of large animal pre-clinical functional studies for devices)
- selecting and working with laboratories and other suppliers/service providers,
- result evaluation, chemical characterisation,
- toxicological risk assessment,
- preparation of complete Biological Evaluation Report.
Our experience covers a very broad range of devices and materials and we are familiar with the different local interpretations of international regulators. Whatever your biocompatibility needs, we will work with you every step of the way.