Training

An introduction to Biocompatibility

Partner with Training Providers

On-Line and Face To Face Training

We partner with a number of training providers to deliver public training course both on-line and in face to face classroom settings. We can also provide tailored in house training courses on all aspects of biological safety assessment of medical devices, GLP compliance and study design.

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.
  • 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.

For further details please refer to one of our key training providers - Educo - Medical Device Training

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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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