From estimating risk to developing a backout plan to establishing a timeframe, effective change control requires diligent planning and execution. This ebook outlines the most important aspects of ...

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 ...

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 ...