In FY2017, FDA inspectors tallied up over 1,000 inspectional observations for medical device organizations. Of those observations, over 400 alone related to design controls—very nearly half of all documented citations. What does that mean for your organization?
In our latest eBook, “FDA Form 483s and Design Controls: The Importance of Managing and Mitigating Inspectional Observations Related to Design Controls,” we dive into the basics of 483s and how they can impact your organization when related to design controls. As well, the paper explores what recent data says about the most commonly cited design controls observations and ways to address them from a holistic perspective.
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