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 ...
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Medical device manufacturers are increasingly implementing integrated mobile software and device applications to automate the inventory management process. By doing so, companies can better track ...
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD).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 ...
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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