• 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.