Biological risk and the biocompatibility of medical devices and their materials are coming under increasing scrutiny from regulatory agencies, which carries an increased risk of both recalls and litigation. This presentation will help guide those working in the life sciences arena in mitigating risks during material selection and biological assessment of their products, as well as understanding how biocompatibility can impact product liability risk.
In this webinar, viewers can expect to learn:
- A brief overview of how biocompatibility is assessed;
- The history of biological safety evaluation from the lens of international guidances and standards; and
- Recent FDA activities pertaining to material safety research.
Kevin Ong | Principal Engineer | Exponent
Dr. Ong is a registered professional engineer. Prior to joining Exponent, Dr. Ong was a research assistant in the Department of Mechanical and Aerospace Engineering at Cornell University, in the Cornell University-Hospital for Special Surgery Program in Biomedical Mechanics. He can be reached at email@example.com or 215-594-8874.