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.
GitLab’s Duo Agent Platform is a new tool enabling government agencies to securely harness AI capabilities. Explore how teams are using it to drive operational efficiency across different deployment scenarios. What You Will Learn In this eBook, you will explore:...
Modern products are becoming increasingly more complex, combining mechanical engineering, embedded software, electronics, cloud connectivity, and regulatory requirements into a single development lifecycle. As that complexity grows, so does the importance of...
Standing on the stage during my breakout session at Atlassian Team ’26 in Anaheim (or even as I entered the main stage where Mike Cannon-Brookes gave his keynote), I looked out at a room full of engineering leaders, IT directors, and others who all seemed to be asking...
Modern access governance depends on automation, but many organizations run into the same problem: not every application has a clean API, SCIM support, or enterprise-ready identity integration. As teams scale, this creates a gap between the applications they need to...