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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The GitLab Duo Agent Platform is changing the game for software developers by providing a place for AI agents to help with planning, coding, security analysis, and analytics. While help from AI sounds great, ROI often falls short due to teams misusing it or failing to...