IMSQ · Institute of MedTech Software Quality
§ 00 — Section 1 · Foundational · free · no login

Is IMSQ a fit? Start with Section 1.

Section 1 is the foundational opening of our SaMD/SiMD Readiness Diagnostic. A handful of questions about your product confirm whether IMSQ is built for you — and show where a full assessment would focus. No login, nothing committed.

§ 01 — Company & product profileA few questions · ~2 minutes

Section 1 — Company and product profile

Q01What best describes your product?

This determines whether IMSQ is the right fit — and how the rest of the assessment branches.

Q02Where is the product in its lifecycle?
Q03Which technologies are in scope?(optional · select all)

Select all that apply — these unlock the relevant assessment sections.

Q04Which markets are you targeting?
Q05What is your highest regulatory ambition for this product?
Q06How would you describe your internal regulatory & quality function?
(answer every required question to continue)

What happens with your answers.

Nothing is shared until you choose a next step. See your fit on screen first. When you send your Section 1 for review or continue into the full diagnostic, your responses go to our programme team so they can tailor your starting point.

This is a fit check, not regulatory advice. It commits you to nothing and is not a substitute for a Capability Gap Assessment.