Angel and seed investors run lighter diligence than a Series B fund — but they probe the same fault lines, and they decide fast. A founder who walks in having already answered the questions below converts skepticism into conviction. Here's the pre-raise checklist, drawn from what actually gets asked.
1 Regulatory: pathway, predicate, and timeline
Know your class, your pathway (510(k)/De Novo/PMA/SaMD), your predicate, and a realistic timeline. "We think it's a 510(k)" is not an answer.
Have ready
Pathway + predicate (with K-/P-number) + the equivalence or evidence basis.
2 Clinical: claims tied to evidence
Every claim should map to the study that supports it. Registered trials and their status are public on ClinicalTrials.gov.
Have ready
Your evidence ladder: what you have, what the next readout proves, and when.
3 Reimbursement & commercial: who pays, and why now
A coding/coverage/payment thesis and a credible first-customer story. (See our reimbursement deep-dive.)
Have ready
Comparable-code reasoning + a named beachhead segment.
4 Team: relevant, named experience
Investors check prior-company history. Name the experience that's relevant; if there's a gap, show the hire/advisor plan filling it.
Have ready
Who has done a version of this before — and the plan for the gaps.
The bottom line
Pre-raise diligence isn't a score — it's a navigation map. Diagnose each fault line, show the path to close it, and arrive having already answered what the investor will ask. That's what gets a fast yes.
Know what an investor will find — first
We'll run a complimentary Signal Brief on your space — a short, fully-cited read drawn entirely from public sources. No cost, no pitch.