If I were to ask you, as business leaders, what keeps you up at night, chances are high that managing change would be at the top of your list. According to a study published in Harvard Business Review ...
It’s rare to hear the private sector applauding a regulatory agency, but the FDA’s Predetermined Change Control Plan (PCCP) deserves recognition. This initiative could be one of the most ...
The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...
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 ...
The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...
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 ...
As companies introduce AI in the workplace, many leaders say they’re shifting their organizational structure, developing a change management strategy and implementing employee communication plans, ...
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.