For any medical device contacting a patient, a biocompatibility evaluation is required before the device can be cleared for the market. This evaluation is usually the last step in device development and is performed per ISO 10993-1. While biocompatibility should be assessed using the final version of the device, it should not be an afterthought; rather, biocompatibility should be an important consideration during the design process. This webinar provides an overview of biocompatibility and the various aspects of a biological evaluation.
About the presenter:
Helin Räägel, PhD
Biocompatibility Expert
Dr. Räägel is a globally recognized expert in medical device biocompatibility. She has extensive expertise in writing biological evaluations and assessments for regulatory submissions. These documents focus on using a risk-based approach in defining the path to evaluating medical devices, with US FDA and EU regulatory bodies as the primary audience.
