From compilation of your biological evaluation plan to preparation of the evaluation report - we support you.
- Customised regulatory consulting for biological safety of medical devices and strategic support, according to the ISO 10993 series and other relevant regulatory requirements
- Data gap analyses and development of chemical and toxicological/biocompatibility testing strategies including preparation of the biological evaluation plan
- Interaction with contract research organizations (CROs) during study management and monitoring
- Scientific literature searches and data evaluation with regards to reliability and applicability for biological evaluation
- Toxicological characterization of raw materials and/or extractables and leachables
- Alternative evaluation approaches, e.g. in silico modelling (Quantitative Structure Activity Relationship - QSAR), read-across, etc.…
- Hazard and exposure assessment as well as risk benefit evaluation for medical devices
- Overall biological safety assessment, and compilation of a biological evaluation report
- Toxicological expert statements, e.g. regarding Carcinogenic/Mutagenic/Reprotoxic (CMR) properties, particle toxicity, etc.…
- Communication with authorities and notified bodies
Specific topics include
Evaluation of zoonosis risks for material of animal origin including annual updates.