On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA ...

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement ...

At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission ...

Imagine walking onto a job site where you’ve worked for decades and suddenly being told that the tools and workflows you’ve trusted are being completely replaced. The promise is a digital ...

At SNHU, we want to make sure you have the information you need to make decisions about your education and your future—no matter where you choose to go to school. That's why our informational articles ...

Change management is a multibillion-dollar industry built on the fundamental claim that most people dislike change, and that someone needs to manage that resistance. But after decades of ...

To achieve success, organizations of all sizes across industries need to be adaptable to change. While change is constant in almost every organization, managing change is easier said than done.

Whether you’re rolling out a new strategy, implementing AI-driven processes, or restructuring your organization, success hinges on how well you identify, engage, and manage stakeholders. These are the ...