Before you build anything, find out how ready your submission actually is. MSI scores you across the domains FDA cares about and hands you the gap report. No login wall, no sales call.
Used by teams at 140+ medical device manufacturers, including 13 of the Top 50.
Finished documents, half-finished documents, or just knowledge of your device. The check meets you where you are.
The workflow mirrors the eStar process your submission will actually go through, scored across the domains FDA reviews.
A domain-by-domain readiness score with your gaps ranked. Green means ready. Red means not. Either way, you'll know.
One number for leadership, with the domain-level detail behind it for your team.
The specific domains where your submission would draw questions, and why.
Gaps ranked by submission impact, so two people can work like ten.
If you want help closing the gaps, MSI picks up exactly where the report leaves off. If not, the report is yours either way.
Five minutes now beats five months later.
