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.
IBM DOORS has remained a consistent tool for managing software requirements. However, it has not kept up with the modern landscape. Explore options such as DOORS NG and other next-generation ALM tools in this eBook.What You Will Learn In this eBook, you will discover:...
Improving Efficiency with the Resources You Have Michael Roberts:Hello everyone. My name is Michael Roberts, Vice President of Sales and Marketing here at SPK and Associates. Welcome to today’s vlog, “Solving the ‘Not Enough People or Time’ Challenge with Atlassian...
When companies develop software, speed and scalability are everything. Yet, as organizations grow, complexity creeps in. Microservices multiply, ownership becomes unclear, and development slows. Atlassian Compass is changing that. Designed to bring visibility,...
Modern software teams may be faster than ever, but they can only release with confidence if they have strong testing practices in place. As distributed teams, hybrid QA models, and rapid DevOps cycles increase, test management tools have become the backbone of...