New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety

Title:  New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety

Speaker: Matt Jorgensen, Nelson Labs

Date: 12/04/2018

Brief Description:
This presentation will provide a snapshot of a shifting regulatory landscape that is evolving with the new release of ISO 10993-1, the MDRs, and draft ISO 10993-18. An overview of the strategic options available for the evaluation of medical device biocompatibility will be provided, including the use of chemistry and biological risk assessments to save time, money, and spare animal life.

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