This diagnostic screens your regulatory and quality readiness for SaMD and SiMD, estimates where the gaps are likely to be, and shows where an engagement should focus. It asks you to name the evidence behind each claim. Answer as you are today. “Unsure” is a valid answer and is never held against you.
The fast first pass. It establishes device nature, target markets, whether the classification holds up, top-level maturity and the biggest gaps. You get a provisional overall maturity level, an early overstatement index and first Expert flags.
The full diagnostic, once your assessment is qualified. It adds every standard dimension with full claim, evidence and confidence capture, mandatory record naming, and the full knowledge-check bank.
Targeted deep dives, opened only for dimensions flagged weak, overstated or high ambition. They refine the effort estimate to 160 or 320 or more hours and settle the Expert engagement profile and the discovery-phase recommendation.
As you answer below, we show which sections your profile unlocks. Nothing here is a score; it only tailors the questions.
Have your QMS, risk file, software lifecycle and submission documents to hand. You will be asked to name the specific record and revision behind each claim.
Where a document does not exist yet, say so. The diagnostic sizes the work ahead rather than grading you, and candour produces a more useful result.
Every answer is saved as you go on this device. Leave and come back; your progress is kept locally so you can pick up where you left off.
Tier 1 is designed for a single respondent, typically the founder or the head of regulatory or quality. The deeper tiers add RA/QA, software and clinical leads, and multi-respondent collaboration opens once your assessment is qualified.