The FDA is allowed to visit your company to perform an inspection. In the course of the visit they may bring some issue to your attention in the form of an observation (aka a 483). This article reviews what a 483 looks like, some of the more common issues flagged in medical device companies, and how to respond.
We invite you to download our paper on the topic of 483 Observations.
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If you work in the software and systems engineering space, you likely understand that managing dependencies across multiple components and requirements is critical for project success. Unfortunately, specifications can be difficult to track, and dependencies hard to...
