Published Date: November 10, 2020
In the evaluation of medical devices for biocompatibility, the assessment of patient safety should be made based on risk rather than on a check-box approach. In this aspect, we will see how to construct a Biological Evaluation Plan as per ISO 10993-1 (2018). The presentation will especially show how understanding patient contact and gathering information is the key in defining an adequate biocompatibility testing program.
Scientific Director, E&L Expert
Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two CROs. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas (US), working on hydrogenated triblock co-polymers. Since 2001, Piet...
