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.
Modern organizations need the latest solutions to keep up with competitors. Explore how integrated ALM tools like Codebeamer can lead to greater ROI.What You Will Learn In this eBook, you will learn: The technical benefits of ALM How to calculate the ROI of your ALM...
Artificial intelligence is rapidly transforming how software teams work. Early AI tools focused on code suggestions and chat-based assistance. Today, the next evolution is underway: intelligent agents that actively participate in development workflows. GitLab’s new...
Medical device companies are facing unprecedented pressure. Regulatory expectations continue to rise, product and software complexity are accelerating, and embedded software is now central to nearly every device. At the same time, patients and providers demand faster...
The speed of software delivery has accelerated dramatically. Between Agile practices, CI/CD automation, and the explosion of GenAI coding assistants, developers can now generate and ship hundreds of lines of code in seconds. However, there is a massive problem no one...