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.
With large scale migrations, large user bases, multiple Atlassian tools, plenty of apps, and lots of data, moving to Atlassian Cloud may feel like a steep mountain to climb. But, it doesn't have to be. In fact, we've already helped many customers make the move. Plus,...
Choosing the right issue and feature tracking tools to manage your software development lifecycle is important. It can be the difference between speed to market, budget savings and even boosting DevOps team morale. Whilst there are plenty of tools in the market, in...
DevOps World 2022 was originally set to take place in Orlando, FL on Wednesday 28th September and Thursday 29th September. Unfortunately, Hurricane Ian had other plans and the DevOps World in-person component was canceled. Instead, a virtual conference was launched....
Data is the most valuable commodity in the modern age. Any good IT business knows that. And customers know it too. They want to ensure the businesses they are providing their data to, know how to keep it safe. That's why cybersecurity, and understanding cybersecurity...
