Many devices.
If your portfolio has ten or more device families, each with its own IFU, manual entry adds up to weeks of regulatory affairs time.
MDIS by MedQAIR
Your document archive in MDIS in days, not quarters.
Manufacturers with hundreds of IFUs, multi-language variants, and years of superseded versions don’t upload them one by one. They run a coding agent against the MDIS API, have it propose the metadata, and let their regulatory team review the diff before anything publishes. Run the agent yourself, or have us run it with you.
Built for Your Role
Built for manufacturers with a real archive
If you have a handful of devices, import them from EUDAMED or a spreadsheet in minutes. This page is for teams moving a real catalogue.
Many languages.
If each IFU exists in five or more languages and supersession rules differ by market, keeping each version correctly mapped is where mistakes creep in.
Years of history.
If you have a document archive stretching back to your first CE mark, migrating that history into a structured system is a project, not an afternoon.
A scripted migration, with your team in the loop
The agent reads the archive
Extract device, document, language, and revision structure from the source collection.
The agent matches against EUDAMED
Compare device identifiers and registration context.
The regulatory team reviews the diff
Experts resolve uncertain mappings instead of guessing.
The agent publishes via the MDIS API
Create reviewed structures and records efficiently.
Run it yourself, or run it with us
Run your own agent
Your engineering or regulatory operations team runs Claude Code, Codex, or a comparable tool against your archive. We provide the MDIS API, schema documentation, and example patterns. You provision a scoped access token for your agent and revoke it when the migration finishes. We do not access your systems.
Run it with us
We work with you to scope the migration, run the agent against a sample of your archive, and hand your regulatory team the same structured diff for review. You sign off on every proposal before it publishes. The script we write is yours at the end.
Nothing publishes without your sign-off
The coding agent reads documents and proposes metadata. It does not decide what is true. Every proposed mapping is reviewed by your regulatory affairs team as a structured diff before it becomes a record in MDIS.
The first migration is the hard one
After the initial migration, your team owns the MDIS API integration and the migration script. Most ongoing document updates happen through your regular QMS workflow. When a large batch lands, the same script runs against the new folder. The script lives in your repository, under your change control.