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Webinar: The Purpose & Value of Chemical Characterization & Biological Risk Assessment in Medical Device Development

May 23 @ 11:00 am - 12:00 pm

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 NAMSA for a webinar on May, 23, 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.

Venue

Webinar
Online Event, OH United States

Organizer

NAMSA
Phone:
(419) 666-9455
Website:
https://www.namsa.com/