Requirements
Preliminary Indications for Use
A description of the way the solution is intended to be used and indications for when it is to be used.
Preliminary Regulatory Classification
Regulatory body (FDA in the US) classification of your product based on products or services that work in similar ways.
Preliminary Regulatory Pathway
The regulatory pathway you expect will be used to approve your solution.
Preliminary Risk and Hazard Analysis
An initial assessment of the potential risks and hazards associated with the results of using the solution