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, ...

OrthoPediatrics Corp. has announced its partnership with the Crossroads Pediatric Device Consortium (CPDC) to enhance the development of innovative pediatric medical devices. This multi-institutional ...

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 ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

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 ...

U.S. medical device companies are adopting digital-first and patient-centric operating models to accelerate innovation while meeting rising compliance and cybersecurity requirements, according to 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 Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Kalorama Information, a market research firm based in Rockville, Md., released a report detailing 10 trends that will likely affect the medical device industry in 2017. The trends are based on the ...

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 ...

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increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...