The workplace has changed forever, having gone through a revolution similar to the Industrial Revolution. Our workplaces are diverse, complex, and frequently changing.

I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls.

Falls are a serious public health issue that result in tens of thousands of deaths annually while racking up billions of dollars in healthcare costs.

Ultrasound imaging is a safe and noninvasive window into the body’s workings, providing clinicians with live images of a patient’s internal organs.

Work has become an around-the-clock activity, courtesy of the pandemic and technology that makes us reachable anytime, anywhere. Throw in expectations to deliver fast and create faster, and it becomes hard to take a step back.

Drugs don’t always behave exactly as expected.

Physicians often query a patient’s electronic health record for information that helps them make treatment decisions, but the cumbersome nature of these records hampers the process.

Close to 9 million people in India suffer from hepatitis C. If left untreated, the virus leads to cirrhosis or liver damage, which eventually causes death from organ failure or cancer.

Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a specific medical device.

The pharmaceutical industry has seen significant upheaval and disruption during the past several years.