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This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...
Kimberlee Leonard has 22 years of experience as a freelance writer. Her work has been featured on US News and World Report, Business.com and Fit Small Business. She brings practical experience as a ...
In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...
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