On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA ...

Too many leaders focus on the mechanics of change and ignore the most critical factor: people. Change is inevitable, but success isn’t. Don’t believe me? Research shows 70% of change management ...

Change is difficult, and the reluctance to change, often on the part of end-user employees, has been at the heart of countless failures of new technology deployments within businesses. Such failures ...

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 ...