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.
The service industry is only becoming more competitive as the years pass, making efficient delivery vital to success. Development and Operations teams need to work together to deliver aid and Jira Service Management can help achieve this. Explore the future of Jira...
Engineering students across the globe often get their first exposure to 3D CAD tools in college. For many, the default software is Solidworks, thanks to its long-standing presence in educational programs. But what happens when these students graduate and enter...
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As new threats emerge, it is becoming vital for security to be integrated into code development processes. Vulnerabilities in code often lead to delays as teams try to balance addressing security concerns with delivering new features. Fortunately, GitLab Duo, GitLab’s...
