Upcoming changes to the general guidance for biocompatibility testing will soon dictate a new approach to biological risk assessment for all types of medical devices. Regulatory agencies will require a more rigorous Chemical Characterization as a prerequisite for biological risk assessment, followed by Toxicological Risk Assessments, to elucidate the need for further testing.
During this webinar, our experts will provide the framework for this new approach to biological evaluation, including:
- Regulatory guidance, including anticipated changes to ISO 10993 series of standards
- How to design appropriate Chemical Characterization studies
- Typical outputs for Chemical Characterization Testing
- A basic framework for toxicological evaluations
- Techniques used to reduce dependence on animal testing
Who should attend?
Managers, directors, engineers and scientists responsible for research and development, product development, quality assurance and regulatory compliance.