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 teams struggle with delays due to inefficient processes. This eBook will explore how automation and proper security practices can streamline Jira management.What You Will Learn In this eBook, you will explore: Common access mistakes How to streamline access...
Many teams struggle with delays due to inefficient processes. This eBook will explore how automation and proper security practices can streamline Jira management.What You Will Learn In this eBook, you will explore: Common access mistakes How to streamline access...
AI appears to be integrated into everything now, but it is essential to ensure that the AI tools your organization utilizes are both secure and efficient. Dive into this eBook to explore why Atlassian Rovo is a trusted AI assistant.What You Will Learn In this eBook,...
As cyber attackers find new ways to infiltrate, it is essential to stay up-to-date with security-related compliance requirements. This eBook explores how to simplify compliance in the software development space.What You Will Learn In this eBook, you will explore:...