MSI answers the three questions every device team asks: Where do I stand? How do I fix it? How do I stay ready? Tools, data, and former FDA reviewers in one place.
Upload whatever you have. MSI scores your readiness across the domains FDA cares about, in a workflow that mirrors the eStar process your submission will actually go through. You get a gap report you can act on the same day. Green means ready. Red means not.
Two paths, depending on where you are today.
You already have documentation. MSI audits your submission package against FDA requirements and produces a findings report that reads like the one FDA would send, with every finding citing the actual requirement. See it now, not six months from now.
You're starting from scratch. Don't build bad documents and fix them later. Build compliant documents from the start in connected workflows: your threat model feeds your risk assessment, which feeds your deliverables. Each output becomes the next input.
Approval is the start, not the finish. MSI keeps monitoring after clearance: automated self-audits replace the slow internal kind, vulnerability monitoring watches your SBOM, and regulatory intelligence alerts you when guidance changes or a customer audit lands. One dashboard, every device, always current.
Every capability maps to a stage of your journey. No separate products to buy, integrate, or explain to procurement.
Drafted from your architecture, in your methodology, checked by former FDA reviewers.
Scan submission packages against requirements and flag what a reviewer would catch.
Structured response support with priority access to reviewer expertise.
Compliant documents built in connected templates, requirements engine included.
Helm keeps your software supply chain visible and your postmarket obligations met.
Encryption, key management, and device identity for connected devices in the field.
Yearly internal audits without the internal resource drain.
Alerts when guidance shifts, mapped to the devices it affects.
Every check, audit, and template in MSI runs on proprietary data about what FDA is actually catching, rejecting, and requiring, built by a team that includes former FDA reviewers and authors of the guidance itself. It's the difference between checking your work against the regulation and checking it against how the regulation is actually enforced.
Starting at $35,000 per product line.
Every tier includes advisory hours and expert submission reviews from a team of former FDA CDRH reviewers and standards authors. The software does the heavy lifting. The humans make the judgment calls.
Check your readiness for free, or talk through your situation with an expert.
