Day Four – 19 June 2025Thursday, 19 June 2025 - CEST Time Zone

• Identifying the intersection of toxicology and biocompatibility

  • When does 1 feed into the other?

• Best practices for identifying the needs of your device

  • When does a device need a toxicological risk assessment?

  • Are there any exceptions?

• Toxicological risk assessment of chemical constituents of medical devices: application of ISO 10993-17

• Hazard identification and implementation of toxicological screening limit

• Biological risk estimation within the risk management framework

• What is cytotoxicity testing?
• Cytotoxicity testing – why does it fail so often?
• Points to consider when Cytotoxicity testing fails
• Case studies

• Working with challenging devices (case examples)
• Handling failing testing
• The importance of feasibility studies

• Review of published literature on the mechanism of Electropolishing
• Review of extractables data from ZB devices to show that Electropolishing can effectively reduce/remove mfg materials used prior
• Application of Electropolishing on future risk assessments
• Similar manufacturing steps (such as anodization and passivation) that provide similar advantages in risk assessments performed per ISO 10993

• With the rise in AI, how are companies applying this to ease biocompatibility workload and analysis?

  • Can generative-AI be used in documentation completion and submission?

• Are notified bodies and regulators accepting of AI use?

  • How is this being regulated?

  • Can we expect further guidance on using AI for biocompatibility?

• Biocompatibility beyond check boxes:

• How to source and analyze post-market data for Biological Evaluations

• Steps to integrate this data and the role of Risk Management

• Discussing real-world examples to demonstrate the process

Following on from yesterday’s morning session, our experts take the time to answer your most asked questions, comments and concerns, as well as answer any left over burning questions!