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.
Modern developers are either upgrading their technology or falling behind. Discover how new CAD technologies and other product design tools are altering the engineering space.What You Will Learn Discover how technologies like Creo and Creo+ from PTC are helping...
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