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.
Security must always be at the forefront of operations in the financial industry, especially when adopting new techniques and technologies. Explore how GitLab ensures safe, secure AI adoption for financial institutions in this eBook. What You Will Learn In this eBook,...
Managing time and tracking productivity is a universal challenge for any team using Jira. Whether you are part of a marketing department, a human resources team, or a project management office, the struggle to maintain accurate records without drowning in manual data...
It’s 2026, and AI is extremely accessible, but knowing how to apply it within your specific business context can be a challenge. To start, LLMs lack the deep, proprietary context of, for example, product requirements or complex assembly structures. Without this...
Modern business tools are rapidly adopting AI, creating a major shift in how organizations work, collaborate, and innovate. Unlike traditional software, AI systems can learn, generate content, and make recommendations in ways that are not always fully predictable. For...