Opportunities lie in offering comprehensive training on global human factors and usability regulations for medical devices, focusing on user-centered design and post-market surveillance. This ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

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 ...

Medical device development has moved to a model where regulatory compliance functions as a primary technical constraint. Engineering teams must treat global frameworks as specifications that dictate ...

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.

ISG has launched a study examining service providers that help medical device companies adopt new technologies and enhance their products.

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, ...

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 ...

PITTSBURGH, Jan. 29, 2026 /PRNewswire/ - MolecuLight today announced that its MolecuLightDX® wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device ...

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has appointed Aaron Pavkov as Chief ...