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.
Developing products can lead to environmental costs based on the materials used and how they are handled pre- and post-production. Let’s explore how Creo helps drive sustainable product development practices.What You Will Learn In this eBook, you will discover how to:...
Protecting documentation inside project tools like Jira Cloud can be a challenge in regulated environments. Whether you're managing technical files, contracts, or quality compliance records, attachments are often scattered and exposed to unnecessary users....
Tariffs have long been a tool of economic strategy, but recent escalations are impacting U.S. manufacturers, especially in the medical device industry. From 10% baseline tariffs to 245% duties on Chinese imports, companies now face inflated costs and disrupted global...
Modern software is assembled from a complex web of components, contributors, and tools, both internal and external. While this modularity accelerates development, it also expands the attack surface. For executives, a single breach in the software supply chain can...