MSI is the single platform for medical device cybersecurity compliance. Tools, data, and expert support to meet FDA requirements and ship on schedule. 100% FDA approval rate, guaranteed.
Free, 5 minutes, no sales call. Prefer a human? Start there instead.
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Three stages. One platform. From first gap check to life after clearance.
Upload what you have. MSI scores your readiness across the domains FDA cares about and shows you the gaps. Green means ready. Red means not.
Have documentation? MSI flags what FDA would catch, in the language FDA uses. Starting fresh? Build it compliant from day one, each output feeding the next.
Approval is the start, not the finish. Automated self-audits, vulnerability monitoring, and alerts when guidance changes, so you never fall out of compliance.
See where you stand in 5 minutes. MSI scores your submission readiness the way an FDA reviewer would, and hands you the gap list. No login wall, no sales call.
Run the free checkBegin with the work that makes your device more secure. Built in your methodology, drafted from the architecture you already have, checked by former FDA reviewers.
Book a threat-model reviewPick the situation that sounds like yours. Each one gets a different first conversation.
Every day of delay costs revenue. Get former FDA reviewers on your response immediately.
Talk to an expert →Find your gaps now, not in a deficiency letter six months from now.
Talk to an expert →Get a portfolio-level readiness picture you can put in front of leadership.
Talk to an expert →Read the state of the union for the first half of the year →
Run the free check or talk to a human. Either way, you'll know where you stand this week.