Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

During an April 7 session of the Biopharma Congress, Janet Woodcock, MD, former acting FDA Commissioner and former principal deputy commissioner of food and drugs, called the recent FDA staff cuts a ...

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.

The recent, rapid advancement of the development of artificial intelligence and machine learning (AI) has revolutionized various industries. It is unsurprising then, that at this year’s South by ...

Much of the conversation about medical device cybersecurity focuses on the new Food and Drug Administration’s (FDA) revised rules for premarket submissions. These regulations changed how devices are ...

In this episode, we are joined by Doug Folsom, President, Clinical Engineering, Cyber Security & Chief Technology Officer at TRIMEDX to discuss how to better understand the growing challenges of ...

The use of smartphones in healthcare is old news. Despite the decade-old trend, many challenges still exist with utilizing a patient’s smartphone, especially with optimizing both safety and patient ...