Features
Most tools hand you a template. This one knows what goes in it.
Connected, not copy-pasted
Each document draws on the evidence already in the platform, and once generated it becomes evidence the next one can draw on. You are not pasting the same numbers between files and hoping they stayed in step.
A requirements engine, not a blank template
Every document is checked against the IEC 62304 and FDA requirements it has to satisfy, with each section mapped to the requirement it answers. Coverage is built in rather than bolted on at the end.
Reviewer-ready, and checked by reviewers
Documents are structured to drop into the templates a reviewer expects instead of being reformatted the week before you file. Former FDA reviewers built the requirement set they are checked against.
How it runs
Evidence in, compliant draft out, your experts in control.
Three stages, and the last one is not a formality. The platform does the drafting and the requirements checking; the judgment that your name goes on stays with your team.
Draft from what you already have.
Generation pulls from your device registry, your threat model, and the document collections you have already uploaded. There is no new intake form to fill in first. The blank page is the slow part of writing a submission, and it is the part this removes.
Documents
Source documentStatusArchitectureParsedInterfacesParsedData flowsReadingExtracting assets and data-flow diagramDrafted into the template, checked against the requirement.
Submissions, labeling, and executive summaries draft inside templates that already carry the structure each one has to have. As it drafts, every section is checked against the requirement it is there to satisfy, so gaps surface while the document is being written rather than at submission review.
510(k) draft
SectionRequirementCheckISO 13485MetISO 62304MetISO 9001ThinTIR 57GapYour name goes on the submission, so your team signs it off.
Your subject matter experts refine the draft, and every drafted answer carries a confidence rating and cites the source document it came from, so review means checking a citation rather than rewriting a paragraph. Our former FDA reviewers then verify the package holds up to submission standards.
Package review
MDS224 citesHighLabeling and IFU18 citesHigh510(k) cybersecurity31 citesMediumExecutive summary9 citesLowRequest changesSign off
What you get
What lands in your hands.
Submission documents
- 510(k) and PMA drafts built inside compliant templates, generated from your device's own evidence rather than from a generic example.
Labeling and IFU
- Instructions for use, warnings, and labeling drafted against the requirements each one has to meet.
Executive summaries
- Concise, submission-ready summaries of the whole package. It is the first document a reviewer reads and the one that frames everything behind it.
A requirements engine
- A categorized library of IEC 62304 and FDA postmarket requirements with evidence linking, so each document maps to what it has to contain and you can show where a requirement was answered.