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.
Software-defined and electric vehicles are only increasing as automotive technology advances. As these features grow, automakers must adapt. Manufacturing a car is not the same as it was years ago. This eBook explores how AI can be used in the automotive development...
Key Takeaways Late-stage changes get expensive fast: The farther a problem travels through design, testing, and manufacturing, the more time, cost, and rework it creates. Disconnected systems and weak traceability are major causes: When requirements, design, software,...
Key takeaways Faster engineering does not always require more headcount: Disconnected systems, manual handoffs, rework, and poor visibility often create more delays than a lack of engineering capacity. A digital thread can eliminate major sources of wasted time:...
Key takeaways Agentic software development goes beyond AI coding assistants: GitLab Duo Agent Platform gives AI agents context across issues, source code, merge requests, CI/CD pipelines, security findings, and development history. GitLab and Gemini combine lifecycle...