The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...
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, ...
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 ...
Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding ...
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 ...
How to Prepare for New Pricing Rules and Consolidation in China's Medical Device Distribution System
Multinational medical device companies have a long history of driving growth through patented products, strong brands, and direct sales force in the United States and Europe. In China, however, ...
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.
Agreement comes on the heels of Company inking an exclusive distribution agreement with Gulf Medical for Saudi ArabiaCreates ...
Zylox-Tonbridge Medical Technology Co., Ltd. ("Zylox-Tonbridge", HKEX: 2190) is a medical technology company dedicated to the innovative research and development, manufacturing and commercialization ...
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increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...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 Master of Engineering (M.Eng.) in Medical Device Development is a cutting-edge program that promises to accelerate the career development of aspiring engineers in all disciplines who wish to pivot ...
MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its ...
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