The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device ...

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 ...

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...

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.

The workplace is becoming more and more volatile, leading to rapid adjustments just to keep up. About 85% of executive leadership agree that the number of change management projects has risen recently ...