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.
Many engineering teams rely on multiple CAD systems across teams. The issue withusing multiple CAD tools is that it can lead to delays and innefficiencies. This white paper explores the benefits of consolidating onto one CAD platform.What You Will Learn In this white...
Many engineering teams rely on multiple CAD systems across teams. The issue withusing multiple CAD tools is that it can lead to delays and innefficiencies. This white paper explores the benefits of consolidating onto one CAD platform.What You Will Learn In this white...
Gen-AI is making its way into nearly all of our tools, and the Atlassian toolkit is no exception. This eBook explores use cases for Atlassian’s AI agent, Rovo. What You Will Learn In this eBook, you will discover how Rovo can help: Engineers ITSM Teams Business...
It’s very rare that an engineering team operates on a single system in today's product development environment. Instead, requirements management, PLM, ALM, DevOps, QA, and ITSM platforms are all part of a sophisticated ecosystem. While each of these instruments...