MDIS by MedQAIR

Release once to every partner who needs it.

MDIS gives manufacturers one technical file per device. Prepare each release, choose what every distributor, importer and authorised representative receives, and let delivery start by itself once the approvals are in.

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Built for Your Role

Your team keeps answering the same request.

Your distributors, authorised representatives, and importers all need documentation to meet their own obligations. Today that often means answering the same request repeatedly through email, portals, and ad hoc follow up whenever a certificate, DoC, or labeling file changes. The real cost is not just the time spent sending files. It is the uncertainty about whether partners are still relying on the right version once the document leaves your hands.

Use one controlled technical file instead of a hundred follow ups.

Keep the technical file in one place

Releases, documents by section and language, registration and UDI identification sit on one device page, the same record your partners receive from.

Tick who receives each document

A grid of documents by partner shows exactly who will receive what before you release. A distributor can get the IFU and certificates while your authorised representative gets the full file.

Every release, as it was delivered

A released version is sealed. When partners or auditors ask what changed, the release history shows what each partner received and when.

What happens when you renew a certificate?

Without MDIS

You receive the renewed certificate, update your internal files, then start emailing the same package to distributors, authorised representatives, and importers. Some ask for additional context, some never confirm receipt, and weeks later you still do not know who is working from the old version.

With MDIS

You add the renewed certificate to a change and release it. Your authorised representative approves, and every partner receives it as soon as the last approval is in. No repeat packaging, no follow-up emails.

When you want more from MDIS

Most manufacturers start with MDIS because a partner invited them. The same record model can then support broader device-data and document workflows without changing how your team works.

eIFU hosting

Publish the IFUs from a release on a public page per device, with a QR code for the label.

EUDAMED-linked device data

Find your company by SRN, import devices from EUDAMED, and check each registration before it is released.

Recorded document history

Every release is sealed and kept, so you never reconstruct what changed from email threads.

Multi-market expansion path

Start with one controlled record model, then extend that same structure into broader market and partner workflows over time.

MDIS device workspace
One working record

See the workflow from invitation to current workspace

  1. Accept the invitation

    Join an operator network at no cost or start your own.

  2. Prepare your first release

    Organise current approved documents and device identifiers.

  3. Choose who receives it

    Assign content to authorised representatives, importers, and distributors.

  4. Release and keep everything current

    Publish once and manage subsequent changes in the same workspace.

Pricing

Pricing that grows with your network

All plans include MedQAIR’s ISO 27001 certified infrastructure, document exchange, version history, and verification evidence.

EUR 199/month can cost less than one failed distributor check. Replace manual verification work across your network.

Your manufacturers can join MDIS at no cost when you invite them to share documentation.

Starter

€199/month

For distributors with a focused manufacturer portfolio

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  • Verification workspace per manufacturer
  • Portfolio overview across all manufacturers
  • Access to declarations, IFUs, labels, certificates, and UDI data
  • Automatic delivery when manufacturers release
  • EUDAMED-linked context
  • Guided onboarding
Most Popular

Growth

€899/month

For growing portfolios across multiple manufacturers

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  • Everything in Starter
  • Bulk portfolio operations
  • Distributor and importer approvals
  • Read-only API access
  • Guided onboarding support

Scale

€2,999/month

For large or operationally complex portfolios

Contact Sales
  • Everything in Growth
  • Advanced bulk onboarding and update tools
  • Full API access (read and write)
  • Priority support
  • Assisted onboarding with data import

Represent unlimited manufacturers. Every manufacturer you invite can join MDIS at no cost.

MDIS is priced to build the network, not to block it.

Small importers can use MDIS at no cost, and manufacturers invited by a paying distributor or authorised representative can join at no cost as well. Paid plans are for organisations running broader partner networks, higher device volumes, and more structured compliance workflows.

Enterprise: For organisations requiring custom integrations, SLAs, or dedicated onboarding Contact Sales ↗

Frequently Asked Questions

Find answers to common questions about our services, compliance processes, and how we can assist your business.

Is MDIS really free for manufacturers?

Yes. When a distributor, authorised representative, or importer invites you, you get a free workspace. You only need a paid plan if you want to use MDIS independently.

What if I want to invite my own partners?

If you want to proactively manage your partner network through MDIS rather than waiting for invitations, you can upgrade to a manufacturer plan that gives you full control.

Can I control which partners see which documents?

Yes. For every release you tick, per document, which partner receives it. New documents start with nobody.

Is my intellectual property safe?

MDIS runs on ISO/IEC 27001 certified infrastructure. Documents are stored with role based access controls so partners only see what your team makes visible.

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See how MDIS works for manufacturers

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