Way back in 2001, MD+DI published an article detailing what the author considered to be The Seven Deadly Sins of Medical Device Development. The author reviewed dozens of device development programs ...

The Atomic Spectroscopy Group at the National Institute of Standards and Technology, which provides definitive measurements integral to developing biomedical instrumentation that helps diagnose health ...

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 ...

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...

Some medical technologies are just plain cool. But tech that’s only cool is never enough. It must solve specific health problems, improve each patient’s quality of care, and be easy to use. To create ...

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.

This online certificate program at Purdue University focuses on regulatory affairs science for medical devices. It equips professionals with knowledge in regulatory processes, quality systems and ...

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access, ...

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 ...

The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation, data ...