Ask for an answer, the supporting evidence, the confidence level, the owner and the date the remaining gap will be resolved. “In progress” without those elements is not a diligence answer.
Questions 1–5
Product definition and claims
- Which exact product version, accessories, software and packaging are included in the investment case?
- What is the documented intended purpose, target user and use environment?
- Do the pitch deck, website, packaging and instructions make the same claims?
- Which planned claims could change the applicable route or evidence burden?
- What product, supplier or software changes are expected before launch?
Questions 6–10
Route, classification and operators
- Which EU frameworks are likely to apply, and what is the reasoning for each?
- Which classification or borderline questions could materially change cost or time?
- Who will act as manufacturer, importer, authorised representative or other required operator?
- Which registrations, notifications or third-party conformity steps are expected?
- Which route assumptions have been validated by an appropriately qualified expert?
Questions 11–15
Evidence and technical control
- Which test reports, declarations and supplier documents exist for the exact finished-product version?
- Which documents cover only a component, older version or different configuration?
- Who owns and controls access to the technical evidence needed after investment?
- What material evidence is missing, outdated or dependent on an uncommitted supplier?
- How are claims, design changes, software releases and supplier substitutions controlled?
Questions 16–20
Budget, timeline and financing
- What is the low–high Regulatory Entry Budget, and which items are still unpriced?
- Which cost items are one-off, recurring, quote-backed or estimated?
- What corrective-work and re-test contingency is included?
- What is the dependency-based critical path from product freeze to market placement?
- Does current runway reach a legally supportable launch and the next financing milestone?
Questions 21–25
Ownership, post-market and deal conditions
- Which executive owns the route, evidence, budget and launch decision?
- How will complaints, incidents, corrective actions and post-market obligations be handled?
- Which open questions must be resolved before close because they could change the thesis?
- Which regulatory milestones should become 30-, 60- and 90-day board commitments?
- What event would trigger a pause, redesign, additional financing or specialist escalation?
Interpretation
How should investors interpret the diligence answers?
Investors should interpret the checklist by testing consistency between the product, claims, route, evidence, budget and financing plan—not by expecting a perfect folder. Early-stage companies will have open work. The material issue is whether management knows what is open, understands the consequence, has budgeted it and controls the next decision. Contradictions between the product, claims, evidence and financial model deserve deeper review.
Proceed
The route is sufficiently supported, exposure is funded and remaining gaps have credible owners.
Proceed with conditions
The route looks manageable, but material assumptions need evidence, budget or post-close governance.
Pause and deepen
A classification, claim, evidence or financing question can still change the investment case.
For a worked example, see the fictional investment memo.
This checklist is general information, not legal, regulatory, financial or investment advice. The right diligence scope depends on the product, claims, markets, company stage and transaction.