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 development comes with the occasional challenge, which is why working efficiently is vital. Here are some ways to ensure your organization is achieving success. What You Will Learn In this eBook, you will discover how engineering leaders can effectively...
Introduction If your engineers can't work smoothly from anywhere or your CAD workstations are slowing down releases, then this video is for you. Today we're talking about moving from on premise to cloud-based CAD and what that journey really looks like. my name is...
In regulated engineering environments, maintaining compliance and managing quality controls are non-negotiable. However, navigating compliance documentation, procedures, and quality workflows can feel overwhelming for engineers. That is where Botable comes in. Botable...
Software development comes with the occasional challenge, which is why working efficiently is vital. Here are some ways to ensure your organization is achieving success. What You Will Learn In this eBook, you will discover how engineering leaders can effectively...