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 ...

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 ...

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increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...

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.

On average, around 4,500 drugs and medical devices are pulled from shelves across the United States each year. 1 This alarming statistic underscores the importance of controlling and mitigating risk ...

This certificate program is designed to prepare biomedical engineers to understand the environment into which their innovations will be placed and the users who will interact with them. Professionals ...

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 ...

WEST LAFAYETTE, Ind.--(BUSINESS WIRE)--MED Institute obtained FDA qualification of their MDDT (Medical Device Development Tool) for virtual MRI safety evaluations, to determine if MRI imaging is safe ...

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, ...