New guidance, updated frameworks, fresh deficiency patterns — staying current is a job by itself. MSI puts FDA guidance, frameworks, and real deficiency letters behind one semantic search, and alerts you when something shifts that affects a device in your portfolio.
Semantic search across FDA guidance and actual deficiency letters, with suggested queries, highlighting, and source attribution on every result.
Changes are flagged against the specific devices they affect, so a guidance update becomes a short to-do list, not a research project.
The FDA Agent answers questions against guidance, vulnerability data, and your own evidence — in conversation, not keyword search.
Missing a change means building to a stale requirement and finding out at submission. Continuous intelligence closes that gap.
What FDA is catching today is what you'll be asked about tomorrow. Reading the deficiency letters is how you get ahead of it.
A searchable, source-attributed knowledge base beats relying on one senior expert's memory — and survives when they're on PTO.
Query guidance, frameworks, and deficiency letters in plain language, or let suggested queries point you at what matters.
Every answer cites its source and is grounded and traceable — no ungrounded claims to second-guess.
Get notified when guidance shifts, mapped to the devices in your portfolio that it touches.
Search across FDA guidance and deficiency letters, with suggested queries, highlighting, and source attribution throughout.
Multi-turn chat over guidance, vulnerability data, and threat intelligence, with conversation history and shared document collections.
Verified, Unverified, and Justified grounding states, plus a tool-call inspector that shows exactly what the agent did to reach an answer.
A searchable knowledge base of FDA guidance and frameworks — plus save-as-skill to turn a useful workflow into a reusable agent skill.
Generic regulatory search returns the text of the rule. MSI surfaces how the rule 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.
Former FDA CDRH reviewers · Authors of the guidance · Deficiency-letter intelligence · Source-attributed answers · Decision Traceability
One look at your portfolio against current guidance. What shifted, which devices it touches, and what to do next.
Search the guidance