Three slides in your pitch deck should answer: (1) what is the regulatory pathway and why, (2) what is the expected timeline with risk-tiered scenarios, and (3) who is on your team and what is their track record.
Avoid weasel words. ‘Class II device pursuing a 510(k)’ is fine. ‘Working with a regulatory advisor’ is not. Name the advisor, summarise their track record, and reference at least one comparable clearance.
Risk-tiered timelines should show base, optimistic and pessimistic scenarios with a clear delta between each.