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.
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:...
Developer experience (DX) is more than just a buzzword. It underpins how fast you can build, how well you deliver, and how happy your engineering team remains. When DX is ignored, you see frustrated developers, siloes, bloated toolchains, and slower innovation. ...
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:...
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,...