Biocompatibility Testing for Medical Devices 2019

Topics

• Overview of collateral standards, i.e., 10993-X
• History of ISO 19993-1
• Review of ISO 14971 Risk management file
• Risk based approach (for Biocompatibility)
• Endpoint assessment vs. testing
• Biocompatibility evaluation endpoints
• Chemical testing: Extractables and Leachables
• Endpoint consideration: Test specific
• Toxicology assessment

Who should Attend

• Technical advisors
• Consultants
• Laboratory Managers
• Product Managers
• Research, Design and Manufacturing Engineers
• Process Development and System Engineers
• Microbiologists and Chemists involved in the evaluation of Medical Devices
• Regulatory Affairs and Quality Assurance Professionals