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...
Deploying software can feel like a gamble due to all the strategies and solutions on the market, but it doesn’t have to be. Discovering which software deployment strategy works best for your organization is a great place to start. This strategy, combined with a modern...
If you work in the software and systems engineering space, you likely understand that managing dependencies across multiple components and requirements is critical for project success. Unfortunately, specifications can be difficult to track, and dependencies hard to...
Is your software delivery process outdated? Modernizing your software delivery workflows does not have to be difficult. Explore this eBook to discover how GitLab can help you modernize your software delivery pipelines. What You...
