Navigating the Full Biocompatibility Workflow to Ensure Product Safety

Biocompatibility is a critical part of the regulatory approval process for most medical devices. Scientific understanding of biological risks and the tools available to assess them are evolving. Regulatory expectations and guidelines are also changing, adding further complexities to the biocompatibility evaluation process.

In order to avoid delays in the development and approval process, it is important to understand the full biocompatibility workflow needed for each unique device.

During this webinar, our expert will guide you through best practices for performing a biological risk evaluation to current standards, including:

• Developing a Biological Evaluation Plan
• The Importance and Nature of Chemical Characterization
• Toxicological Risk Assessments of chemical characterization data
• Selecting appropriate In vivo and in vitro tests
• The FDA’s new ASCA Program – differences and benefits
• Constructing a Biological Evaluation Report
• Common challenges

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