Your threat model feeds your risk assessment, which feeds your submission. MSI generates regulatory documents inside connected templates, 510(k)s, PMAs, labeling, executive summaries, with a requirements engine that knows what each one has to contain. Each output becomes the next input, so nothing is written twice and nothing is missed.
Outputs flow from one document to the next. Your threat model populates your risk assessment; your risk assessment shapes your deliverables.
Every document is checked against the IEC 62304 and FDA requirements it has to satisfy, so completeness is built in, not bolted on.
Documents are structured to drop into the templates a reviewer expects, not reformatted at the last minute.
Drafting from your own evidence beats starting cold every time. The first pass is the slow part, and that is the part MSI takes off your plate.
Fixing documents at submission time is the expensive way to do this. Build them right once and the corrections don't pile up.
Connected workflows mean your numbers, claims, and controls match across every document, the inconsistencies a reviewer loves to find never appear.
Pull from your device registry, threat model, and existing collections. The documents draft from what you already have.
MSI drafts submissions, labeling, and executive summaries, with each output feeding the next in the chain.
Your SMEs refine the draft; former FDA reviewers verify it holds up to submission standards.
510(k) and PMA drafts built inside compliant templates, generated from your device's own evidence.
Instructions for use, warnings, and labeling generated to the requirements each one has to meet.
Concise, submission-ready summaries produced through the HELM service, the document that frames the whole package.
A categorized library of IEC 62304 and FDA postmarket requirements with evidence linking, so each document maps to exactly what it must contain.
Most generators produce a document and call it done. MSI builds yours against how the regulation is actually enforced, informed by proprietary data on what FDA is catching and requiring, by a team that includes former FDA CDRH reviewers and authors of the guidance itself. Automation for the draft, reviewers for the judgment.
Former FDA CDRH reviewers · 510(k) / De Novo / PMA · IFU & labeling · IEC 62304 · HELM executive summaries · Connected workflows
One session on a real deliverable. Your evidence in, a compliant draft out, your experts in control.
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