I t wasn’t that long ago that GM ran commercials advertising that its Oldsmobile division didn’t just produce cars for your grandfather, but also for everyone else. It was an attempt to reinvent the brand’s staid image—and it didn’t work.

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.

ISO 9001:2015, Clause 4.2—“Understanding the needs and expectations of interested parties” requires the organization to determine the “requirements of these interested parties that are relevant to the quality management system.” When customers block an organiz

The tragic shooting in Orlando brought dozens of victims to emergency rooms. Even now, several of those people are still clinging to life. Many across the nation are praying for them and the other victims.

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.

What does the eyesight of a homeless person have in common with complications from dental anesthesia? Or with reducing side-effects from cancer? Or monitoring artificial hip implants?