Items Tagged with 'FDA regulations'

In 2025, medical device manufacturers are grappling with heightened regulatory uncertainty, leading to slower reviews and communication difficulties with the FDA. This situation drives them to reassess operations for compliance and risk management, with a strong emphasis on maintaining product quality, which is vital for patient safety.

Quality is honored to name Attrayee Chakraborty as our 2025 Quality Rookie of the Year. Discover how she earned the award through her groundbreaking work in medical device quality and AI integration.

Michelle Bangert, who is the managing editor of Quality, has a chat with Greg Weaver from Weaver NDT about additive manufacturing inspection.

With the ever-increasing complexity involved with the provision of products and services, the demand for competent workers will undoubtedly increase.

We review essential software specifications and cover how those attributes can be leveraged when considering computer-controlled physical product testing equipment in the lab or on the shop floor.

Medical devices can present unique challenges for manufacturers. Consequences for malfunctioning equipment can be dire. Because of this, medical device manufacturers must work hard to ensure that their products never fail.

The medical industry stands out from other aspects of manufacturing. The inspection rates are often higher, quality is paramount, and the products could be implanted into the human body.

Which is more important to you: complying with industry and federal regulations, or improving the efficiency and profitability of your operations?

For medical device manufacturers, having a product that functions as designed is critical, as a person’s health—or even their life—could be at risk. It’s one thing if my Alexa won’t respond to a voice command to remind me of a task, but it may be life threatening if my asthma inhaler won’t give me the medication I need when I’m struggling to breathe.