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Design Change Impact on Biocompatibility and Documentation

Published Date: August 25, 2021

Change Management, especially related to a medical device’s design, is one of the most commonly-cited issues in FDA 483s and Warning Letters. Unfortunately, change is constant in the medical device industry, so it’s imperative to learn how to effectively evaluate change and incorporate findings into biocompatibility testing and documentation.

In this webinar, industry experts from Nelson Labs and Greenlight Guru will teach you how to:

  • Accurately identify change
  • Evaluate change’s impact on biocompatibility and testing
  • Effectively and proactively document changes
  • Remain compliant when changes inevitably occur


  • Thor Rollins, Nelson Labs
  • Jon Speer, Greenlight Guru

Complete the following information to access the webinar.