I’m a dragon wrangler. Although that might sound like something straight out of Harry Potter or Game of Thrones, this isn’t fantasy—it’s serious science.

Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.

Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.