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 ...

Why is it necessary to develop human resources for developing medical devices? Muragaki: Medical devices tend to be over-imported, with data for 2021 showing a trade deficit of 1.8 trillion yen. In ...

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 ...

In medical device development, packaging is often treated as a finishing step. Once a sterile barrier passes seal strength testing, aging, and simulated distribution, it is generally considered ...

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

This workshop is designed to help regulatory and product development teams successfully bring AI/ML-enabled medical devices to market. You will learn global reg. perspectives from the US FDA, EU MDR ...

A rendering of Aggie Square, the UC Davis science, innovation and learning hub in Sacramento. The UC Davis Department of Biomedical Engineering is launching a new nine-month master’s degree program in ...

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, ...

As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial ...