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.
GitLab’s Duo Agent Platform is a new tool enabling government agencies to securely harness AI capabilities. Explore how teams are using it to drive operational efficiency across different deployment scenarios. What You Will Learn In this eBook, you will explore:...
GitLab’s Duo Agent Platform is a new tool enabling government agencies to securely harness AI capabilities. Explore how teams are using it to drive operational efficiency across different deployment scenarios. What You Will Learn In this eBook, you will explore:...
When it comes to AI, balancing safety and security with innovation is vital for peak efficiency. This eBook explores how to achieve success with AI governance.What You Will Learn In this eBook, you will discover: Why AI governance matters The role of AI governance...
Complex product development involves multi-disciplinary teams, with systems engineers or requirements analysts producing the requirements, and other disciplines creating designs and tests based on those requirements. Serious problems can arise if all teams do not have...