Biocompatibility Testing for Medical Devices 2019 is a seminar that covers topics such as:
- 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
Biocompatibility Testing for Medical Devices 2019 brings together:
- 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