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1) Scope & Device Description
2) Equivalence
3) State of the Art (SOTA)
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4) Similar Devices
5) Device Claims
6) Literature Search, Vigilance Search and Appraisal Plan
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7) Clinical Investigation
8) Article 61(10) under MDR
 
9) Stratification of Data & Analysis
10) Benefit / Risk Assessment
 
11) Updates & Other Considerations
12) Evaluator & Competences
