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Software Design
Alignment with clinical
guidelines and ensuring that
there are no contradictions
Pre-Market
Validation
Back-end testing of
software success rate and
safety, and demonstration
that clinical diagnosis is at
least as good as the
standard of care
Real-word data collection beyond the initial intended-use patient population, also including "similar indications''
Real-world data
processing and
providing decision
support for clinical
diagnosis
Post-Market Phase
A secured process protected by patient privacy rules
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