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 ...
To protect both the user and patient, medical device developers must pay strict attention to the safety of a device's software. Risk-mitigated software design is crucial. Timothy Cuff and Steven ...
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The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
Generative artificial intelligence powered features such as chatting about what is in pictures, telling children bedtime stories, and imitating podcasters continue to roll out despite fears the ...
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Propel Software, creator of the first product value management (PVM) platform that transforms how businesses create, market, sell, and service products, has ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
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