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FDA De Novo Classification Strategy
How E&E Medicals Helped an AI-Powered Medical Technology Company Establish a New Regulatory Classification and Accelerate Market Entry
· Clinical usability
· Workflow integration
· User comprehension
· Diagnostic consistency
· Clinical efficiency
· Safety monitoring
· Human factors
· Real-world usability
Study endpoints were selected to provide meaningful evidence supporting the proposed intended use while avoiding unnecessary complexity.
Risk Management
Risk management activities extended throughout the software development lifecycle.
Potential hazards included:
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