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.
