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:...
Software delivery success relies on two main aspects: speed and security. However, a survey of senior IT and security leaders across North America reveals a sobering truth: 62% of organizations knowingly release insecure code just to meet delivery deadlines. Despite...
In modern software development, visibility drives velocity. Engineering leaders can’t improve what they can’t see. When delivery pipelines span dozens of tools and teams, measuring progress becomes even harder. That’s why the best organizations rely on actionable,...