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 aerospace industry is facing a slowdown in development timelines and higher quality costs. A digital thread resolves these issues by creating a unified, intelligent product lifecycle that connects design, manufacturing, and service.What You Will Learn In this...
As AI rapidly changes software development, many organizations are asking the same question:How do we invest in GitLab Duo, AI agents, and new DevSecOps capabilities without constantly going back through procurement?For years, GitLab licensing has largely been...
Introduction Michael Roberts: Hello, and welcome to another SPK and Associates vlog. As we probably are already well aware, if you're watching this video, artificial intelligence is evolving at a remarkable pace, and the conversations around AI are quickly shifting...
Modern software delivery in regulated industries requires more than just a place to store code. It requires a robust, automated engine that can handle the rigors of CI/CD while maintaining strict compliance and security standards. In the GitLab ecosystem, this engine...