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.
Gen-AI is making its way into nearly all of our tools, and the Atlassian toolkit is no exception. This eBook explores use cases for Atlassian’s AI agent, Rovo. What You Will Learn In this eBook, you will discover how Rovo can help: Engineers ITSM Teams Business...
The future of Atlassian is here! Leap into the future with Atlassian cloud and unlock speed, scale, and AI-powered teamwork. Atlassian has announced the sunset of Data Center products by March 2029, marking a pivotal shift to a cloud-first future. From Data Center to...
As organizations look to simplify their DevOps toolchain, improve cost predictability, and strengthen security, many are making the shift from GitHub Actions to GitLab CI. This eBook provides a step-by-step migration checklist to help engineering teams transition...
Gen-AI is making its way into nearly all of our tools, and the Atlassian toolkit is no exception. This eBook explores use cases for Atlassian’s AI agent, Rovo. What You Will Learn In this eBook, you will discover how Rovo can help: Engineers ITSM Teams Business...