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.
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...
In many organizations, systems operate independently, creating a large visibility problem. A digital thread addresses this by creating a connected flow of product information across the lifecycle. This playbook explains why engineering visibility matters, and how...
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