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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Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves ...
On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support ...
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD).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 ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
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 ...
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