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.
Jira is a great project management tool, but it can easily become cluttered. Dive into this eBook to explore how to clean up your Jira instance easily.What You Will Learn Discover the tools that can help you: Remove and merge old or duplicate content Fix broken...
Automotive innovation is moving faster than ever, thanks to the rise of software-defined vehicles, electrification, and automation. Amid this rapid evolution, one constant remains: compliance. Meeting functional safety, cybersecurity, and quality standards is...
Software teams live in a constant tradeoff of building what’s next or fixing what’s already present. If you don’t manage tension with structure, you get chaos. This can look like surprise scope creep, invisible maintenance work, reactive firefighting, or a codebase...
Modern engineering teams depend on CAD tools to design, innovate, and deliver high-quality products. However, even the best design tools can’t perform to their full potential with poor file management. Unorganized CAD files slow workflows, cause version confusion,...