The Purpose and Value of Chemical Characterization and Biological Risk Assessment in Medical Device Development

Release Date
May 23, 2017

To register for the recording of this webinar, please visit the webinar’s registration page.

Medical device organizations that manufacture products that involve patient contact are almost always required to perform biological safety evaluations, per ISO 10993-1, to ensure end-user safety.

On June 16, 2016, the U.S. Food & Drug Administration (FDA) further expanded – and clarified – how device manufacturers seeking U.S. market clearance should comply with this standard as it relates to the evaluation and testing of devices throughout the risk management process. Using a risk-based approach, the FDA guidance includes detailed recommendations for all aspects of biological safety evaluation, including biocompatibility testing.

Join us for our webinar on May, 23, 2017 or May 24, 2017, with NAMSA expert, Amy Hoffmann, to learn about the benefits of the FDA Guidance and ISO 10993-1 standard, and how manufacturers can use chemical characterization and biological risk assessments (BRAs) to demonstrate biological safety for their devices.

Specifically, we will discuss how to:

Time will also be allotted for discussion of real-world case studies and Q&A.

To listen to the recording, please visit our registration page.