This webinar will go over the information needed and the important points that should be included in the report.
The three main steps in developing a Biological Safety Evaluation (BSE) are:
1) Biological Evaluation Plan (BEP)
2) Perform Testing and Written Risk Assessments
3) Biological Evaluation Report (BER)
This webinar will also include discussion of how to assess the biocompatibility of device and process changes. Composed of a 50-minute presentation followed by a Q&A session, the webinar will cover the broad scope of developing a biological safety evaluation. This webinar will be based on ISO 10993-1 and the FDA Guidance document on ISO 10093-1 (effective September 2016).