Why Should You Attend:
All medical devices that have direct or indirect contact with the human body require an assessment of the biocompatibility of the materials used to manufacture the device, with the test schedule depending on the nature and duration of body contact. Domestic and international regulatory bodies are encouraging the use of risk-based approaches to assess biocompatibility rather than strictly following the specified testing matrix.
The objective of the Webinar is to teach participants how to use ISO 10993-1 and FDA standards to establish a biological safety evaluation plan, including how to document and implement their plan. Participants will not only learn how to assess their device for biological risks but also understand when testing is not necessary.
Areas Covered in the Webinar:
- Risk-based approach to Biocompatibility evaluation strategy
- Overview of ISO 10993-1
- Biocompatibility testing guidelines, costs, and turnaround times
- Leachables and extractables (L&E) testing as an alternative to costly
- Time-consuming long-term animal testing
Medical Device Consultant,
Syntilla Medical LLC