An introduction to Biocompatibility

In House Training

On-Line and Face To Face Training

We can provide in house training to help your safety, regulatory or R&D teams develop their understanding of biocompatibility and biological evaluation of your medical devices. The training can be tailored to your specific requirements but the areas we typically cover include:

  • An introduction to biocompatibility
  • The ISO 10993 series
  • Regulatory standards
  • Impact of MDR and Brexit
  • Gap analysis of existing dataMedical device categorization for biological risk assessment
  • Endpoints to be addressed in a biological risk assessment
  • Contract Lab selection and GLP
  • Physical and Chemical characterisation
  • Extractables and leachables testing
  • Toxicological risk assessment
  • Change Management
  • Use of data sources/literature to provide chemical information
  • International requirements
  • Gas Pathway devices.

Developing the most practical path forward for your product

Biological safety is a continuous process throughout the lifecycle of a medical device.

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