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, ...

In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...

To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission ...

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increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...

Imagine a world where hackers can easily hijack the software controlling a ventilator or breach patient data. The ...

Medical device development is complex, costly, and time-intensive. This buyer’s guide shows how leading OEMs use 3D printing to streamline design, prototyping, and production. Learn how to cut up to ...

Successful new medical devices hinge on the designer’s understanding of the specific requirements of the procedures they support, including factors like usage frequency and duration. This is ...

In recent years, pharmaceutical companies have broadened their horizons, moving beyond drug development to enter the medical device market. This strategic shift allows pharma to offer integrated ...

Objective Medical devices account for approximately 6–10% of national health systems’ carbon footprints. The global use of single-use devices has increased, with implications for health systems’ ...

FORT DETRICK, Md. -- Sustainment experts at U.S. Army Medical Logistics Command have developed new maintenance handbooks aimed at improving resource management practices and overall readiness for ...