This diagnostic scores your maturity against the standards that govern your submission — and shows where an engagement should focus. It asks you to name the evidence behind each claim. Answer as you are today; “Unsure” is an honest, valid answer and is never held against you.
Fast lead qualifier. Establishes device nature, target markets, classification sanity, top-level maturity and the biggest gaps. Produces a provisional overall maturity level, an early overstatement index and initial SME flags.
Full diagnostic for qualified opportunities. Adds all standard dimensions with full Claim-Evidence-Confidence capture and mandatory artifact naming, plus the full interleaved knowledge-check bank.
Targeted deep dives, triggered only on dimensions flagged weak / overstated / high-ambition. Refines effort to 160/320+ and finalises the SME engagement profile and discovery-phase recommendation.
Tier 1 is designed for a single respondent — typically the founder or head of regulatory or quality. The deeper tiers add RA/QA, software and clinical leads; multi-respondent collaboration is available once your assessment is qualified.