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 ...

Today’s medical devices are very sophisticated, with more providers serving applications in software as well as hardware. These devices are becoming more intelligent and can be tailored to be ...

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 ...

STAMFORD, Conn.--(BUSINESS WIRE)-- U.S. medical device companies are adopting digital-first and patient-centric operating models to accelerate innovation while meeting rising compliance and ...

In recent years, pharmaceutical companies have broadened their horizons, moving beyond drug development to enter the medical device market. This strategic shift allows pharma to offer integrated ...