Biological Safety

From compilation of your biological evaluation plan to preparation of the evaluation report - we support you.

knoell Biological Safety
  • 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.