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.
As AI becomes more integrated into our business processes, expectations have changed. Navigating these new technologies and expectations can be challenging. This eBook explores how to make the most of this new way of working.What You Will Learn In this eBook, you will...
Implementing successful DevOps workflows for your software developers should lead to faster delivery. However, many organizations find themselves asking a critical question: why does it still feel slow? The answer is often hidden in how time is actually spent across...
As organizations look to simplify their DevOps toolchain, improve cost predictability, and strengthen security, many are making the shift from GitHub Actions to GitLab CI. This eBook provides a step-by-step migration checklist to help engineering teams transition...
For decades, physical CAD workstations have been the backbone of engineering teams. High-performance desktops packed with powerful CPUs and GPUs have long been considered essential for design, simulation, and product development. However, as engineering workflows...