Your submission package is going to be reviewed against FDA's requirements, line by line. MSI runs that review first, scanning your design and documentation against the requirements a reviewer actually applies, and producing a findings report that mirrors how a reviewer documents gaps. So you can fix the gaps on your own schedule, before the review clock starts.
Findings are phrased the way a reviewer phrases them, and each one cites the requirement it maps to. No vague "improve your documentation", the actual gap, against the actual rule.
The checks reflect what FDA is actually catching, rejecting, and requiring, not just what the written guidance says. The difference between checking against the regulation and checking against how it's enforced.
The scan reads your threat model, risk assessment, and SBOM as one body of evidence, the same way a reviewer does. Gaps between documents surface, not just gaps within them.
A hold letter costs months. Catching the same gap before you submit costs an afternoon. The scan tells you where you stand against the requirements while you can still do something about it.
Each finding cites the requirement it came from and shows the evidence behind it, verified against your documents, or flagged honestly when the support isn't there. You and your regulators can audit exactly why the platform said what it said.
Run it on every device, not just the one with a deadline. The same scan that pressure-tests one submission keeps your whole portfolio review-ready.
Upload your submission documents, or pull them from your existing collections. No reformatting, no new templates.
MSI compares your design and implementation against FDA expectations and flags the gaps, aligned to the eSTAR structure your submission will actually move through.
Former FDA reviewers (CDRH, the Center for Devices and Radiological Health) help you triage what matters, separate the real risks from the noise, and shape the response.
An AI-driven design and implementation gap analysis that compares your device against your submission documents, every finding mapped to the requirement behind it.
A guided checklist that mirrors the FDA 510(k) and De Novo submission structure, so you always know how close to ready you are.
Identify compliance gaps against the relevant standards and track each one through to closed, progress you can show, not just a list you generated.
Every claim cites its source, and every human reviewer change is captured in an audit log. Built for the clients and regulators who need to audit the audit.
Most tools check your package against the regulation. MSI checks it against how the regulation is actually enforced, built on proprietary data about what FDA is catching, rejecting, and requiring, by a team that includes former FDA CDRH reviewers and authors of the guidance itself. Automation for the scan, reviewers for the judgment.
Former FDA CDRH reviewers · eSTAR-aligned · 510(k) / De Novo / PMA · Section 524B aligned · Enforcement Intelligence · Lifecycle maintained
One scan on your real package. The gaps a reviewer would flag, while you still have time to fix them.
Scan your submission package