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.
Adopting cloud technologies can lead to benefits such as enhanced collaboration or expedited decision-making. Explore how the collaboration between Atlassian and AWS achieves these results.What You Will Learn In this eBook, you will discover: Key benefits of cloud...
Whether moving to the cloud, shifting to another hypervisor, or refreshing your hardware, your team needs a proper strategy. Dive into this eBook to guide you through VMware modernization.What You Will Learn In this guide, you will discover: Reasons for migrating to...
Key Takeaways AI pilots often struggle in production because real enterprise environments are complex. Legacy systems, fragmented data, security requirements, and compliance constraints can quickly expose the limits of a successful demo. Forward Deployed Engineers...
Key Takeaways: AI is changing simulation from a late-stage validation step into a continuous part of product development, helping teams explore more designs, automate setup, and support predictive digital twins. AI-driven simulation still depends on high-performance...