Introduction
Does your company properly manage Design Outputs? The FDA routinely examines this area as part of an audit process. In this article we review what it means to have your design outputs in order as well as present some recent warning letter examples.
We invite you to download our paper on this topic.
Learn more about IT FDA requirements and compliance training best practices to help your business gain the competitive market advantage.
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...
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...
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...