Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.

This story was originally published by Knowable Magazine.

This story was originally published by MIT News.

During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate.

Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.” Reimbursements that take months to process.

Here’s an unfortunate truth: The story of the Covid-19 pandemic is one of epic quality failures in almost every area imaginable.

Ending the pandemic depends on achieving herd immunity, estimated at 70 percent or

Artificial intelligence holds great promise for improving human health by helping doctors make accurate diagnoses and treatment decisions. It can also lead to discrimination that can harm minorities, women, and economically disadvantaged people.

Recent surveys point to increasing frustration and, frankly, exha

More than 50 million Americans have received at least one dose of either the Pfizer or Moderna Covid-19 vaccine.