Get exactly what's meant for you
Manufacturers choose which approved documents each operator receives.
MDIS by MedQAIR
Every document your manufacturers release to you, in one place.
Receive, verify, and retain the exact device documents your manufacturers release to you, with a dated record of what your team relied on.
Built for Your Role
Every party in the chain is legally responsible. None of them are looking at the same documents.
Forwarded emails and shared-drive links make it difficult to prove which approved version was checked. MDIS gives distributors a controlled, current record per device and manufacturer.
Verify from what was delivered, not from whatever PDF someone last forwarded.
Open the current device detail
See releases, registrations, documents, partners, and verification context together.
Prove which version you relied on
Keep dated delivery and verification evidence attached to the device record.
Beyond Verification
More than a document inbox
Role-based access
Distributor users see only what each manufacturer released to them.
EUDAMED-linked context
Keep UDI, Basic UDI-DI, class, and visible status attached to the device workspace your team is checking.
Structured document history
Every delivered release, with its documents and date, instead of whoever forwarded the latest file.
In Practice
What happens when a competent authority calls?
Fictional sample data
Without MDIS · ~ 2 Days
You search email for the manufacturer’s last package, discover it is stale, then start a new request cycle while the authority waits. The work turns into a scramble because the device detail, visible documents, and partner permissions all live in different places.
With MDIS · ~ 1 hour
You open the device, see the release delivered to you and its date, and answer from the same record. Documents, UDI and delivery history are on one screen.
One working record
From first search to ongoing compliance
Connect your manufacturers
Invite existing partners or accept their connection.
Review and verify
Check the current released documents and record the verification.
Stay current in the same workspace
New approved releases arrive without rebuilding the file.
Respond with confidence
Open the dated record when a competent authority asks.
Built for You
Built for the way distributors actually work
Built for lean compliance teams
Most distributors do not have large regulatory departments. MDIS is designed to make verification manageable without turning every request into a project.
Manufacturers benefit too
When you invite manufacturers into MDIS, they release once and every partner works from the same delivered version.
Scale without scaling your team
Whether you work with 5 manufacturers or 500, the verification flow stays consistent because the device workspace does not change with every request.
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
Start Trial- 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
Growth
€899/month
For growing portfolios across multiple manufacturers
Start Trial- 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.
Structured Article 11 evidence across represented manufacturer portfolios.
Starter
€199/month
For ARs with a small manufacturer portfolio
Start Trial- Verification workspace per manufacturer
- Article 11 evidence trail across represented manufacturers
- Documentation access and sharing
- EUDAMED-linked context and XML workflow support
- Certificate and expiry tracking
- Manufacturer invitations at no cost
- Guided onboarding
Growth
€899/month
For growing AR portfolios needing operational scale
Start Trial- Everything in Starter
- Bulk device import from EUDAMED
- Bulk portfolio operations
- Read-only API access
- Guided onboarding support
Scale
€2,999/month
For large AR portfolios managing hundreds of manufacturers
Contact Sales- Everything in Growth
- EUDAMED M2M submission
- Advanced bulk onboarding and update tools
- Full API access (read and write)
- Assisted onboarding with data import
- Priority support
Invite represented manufacturers at no cost and manage the portfolio from one workspace.
If a distributor or authorised representative invited you to MDIS, you already have free access. Paid plans are for manufacturers managing their own partner network.
Starter
€199/month
For manufacturers managing their own partner network
Request Invite- Shared compliance workspace
- Publish once to distributors, authorised representatives, and importers
- Document versioning and partner access control
- EUDAMED-linked context
- EUDAMED XML workflow support
- Certificate and expiry tracking
- Automatic partner notifications on updates
- Guided onboarding
Growth
€899/month
For multi-device or multi-market manufacturers
Start Trial- Everything in Starter
- Bulk device and documentation management
- Read-only API access
- Guided onboarding support
Scale
€2,999/month
For large or operationally complex manufacturer portfolios
Contact Sales- Everything in Growth
- Full API access (read and write)
- Advanced bulk onboarding and update tools
- Assisted onboarding with data import
- Priority support
MDIS is free for manufacturers invited by a paying distributor or authorised representative.
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.
Do my manufacturers need to pay to use MDIS?
No. When you invite a manufacturer, they can join at no cost. They only need a paid plan if they want to use MDIS independently.
What if a manufacturer is already on MDIS?
If a manufacturer is already using MDIS with another partner, connecting to them is instant because the shared device workspace is already structured.
What documents can I access?
Declarations of conformity, CE marking status, labeling materials for your region, UDI data, and certificates. Manufacturers control what each partner sees.
How does MDIS handle multiple jurisdictions?
MDIS keeps the visible device workspace and document context organised in one place so your team can review what is relevant without rebuilding the picture from multiple systems.
Is my data secure?
MDIS runs on ISO/IEC 27001 certified infrastructure. Documentation is stored with role based access so distributor teams work from the records made visible to them.
How is this different from asking manufacturers to email documentation?
Email works until it does not. Documents get lost, versions become outdated, and teams stop trusting which file is current. MDIS replaces that with a controlled, traceable device workspace.