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 ...
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 ...
PCCPs allow device manufacturers to implement preapproved modifications to their devices in lieu of obtaining separate authorizations for each significant change prior to implementation. A PCCP ...
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 The first is a draft guidance outlining categories of clinical decision ...
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...
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 ...
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