How to Build Medical-Device Usability Testing and Validation Into Your Quality System
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.
Remote Work Can Be a Lot Better Than This
This story was originally published by Knowable Magazine.
A Method to Assess Covid-19 Transmission Risks in Indoor Settings
This story was originally published by MIT News.
FDA’s Ongoing Use of Inspectional Tools During the Covid-19 Pandemic
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.
The Staggering Costs of Health Insurance ‘Sludge’
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.
Quality Management Can’t Be Optional Anymore
Here’s an unfortunate truth: The story of the Covid-19 pandemic is one of epic quality failures in almost every area imaginable.
Three Ways Employers Could Help Fight Vaccine Skepticism
Ending the pandemic depends on achieving herd immunity, estimated at 70 percent or
Biased AI Can Be Bad for Your Health
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.
Nurses Are Stretched Thinner Than Ever: Are Hospitals Doing All They Can?
Recent surveys point to increasing frustration and, frankly, exha