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Pricing

Transparent Pricing for Regulated Industries

A flat plan fee, the required Core QMS, and only the module bundles you need. Real prices, published up front. The smallest paid setup is €548 per month.

From €548/month
Flat plan fee, users included
14-day trial on request

Prices exclude VAT. Your final price is confirmed in your quote.

Organizations: unlock 2 months free with a partner code

Request a partner code

14-Day Trial

Request a trial

Try the Core QMS with your own team for 14 days. No credit card. We activate your workspace after a short review.

Free

14 days, on request

No credit card. Activated after a short review.

Request a 14-day trial
  • Up to 3 users
  • Core QMS modules
  • 1 GB storage
  • No credit card required
  • Full audit trail
  • EU-hosted

Foundation

Good for startups

For startups and small teams building their first QMS. Plan fee plus the required Core QMS (€499/mo): from €548/mo.

€49

/per month, flat · up to 10 users

+ required Core QMS (€499/mo) + bundles. From €548/mo.

Talk to us about Foundation
  • Up to 10 users included
  • Core QMS required (€499/mo)
  • Up to 3 add-on bundles
  • 5 GB storage
  • Part 11-ready e-signatures
  • Email support
  • EU-hosted
Most Popular

Growth

For scaling teams

For growing companies with more users and more modules. Plan fee plus the required Core QMS (€499/mo): from €578/mo.

€79

/per month, flat · up to 50 users

+ required Core QMS (€499/mo) + bundles. From €578/mo.

Talk to us about Growth
  • Up to 50 users included
  • Core QMS required (€499/mo)
  • Up to 6 add-on bundles
  • 25 GB storage
  • REST API, SSO and Priority Support available as add-ons
  • Email support
  • Customer Validation Guide with IQ/OQ/PQ templates (under NDA)

Enterprise

All bundles

For established manufacturers who want every bundle, including EU AI Act. Plan fee plus the required Core QMS (€499/mo): from €628/mo.

€129

/per month, flat · unlimited users

+ required Core QMS (€499/mo) + bundles. From €628/mo.

Talk to us about Enterprise
  • Unlimited users
  • All 14 bundles, 130+ modules
  • 100 GB storage
  • EU AI Act bundle available (Enterprise)
  • REST API, SSO (OpenID Connect) and Priority Support available as add-ons
  • Email support
  • EU-hosted and operated by MoniDose

Estimate your cost

See exactly what you'll pay

One simple formula: plan fee (flat, users included) + Core QMS + the bundles you choose. Set yours below and watch the total update.

Quick start:

How many users?

users

Choose your module categories

Core QMS is required on every paid plan. Add only the bundles you need.

Core QMS — Document Control & Quality
Required · 16 modules
€499/mo
Recommended planFoundation

Up to 10 users · up to 3 add-on bundles

Foundation plan (flat, up to 10 users)€49
Core QMS (required)€499
Risk & Vigilance€199
Design & Development€149
€896
per month
€10,752/yr
26 modules

2 add-on bundles selected.

Request a 14-day trial

Estimate only. Prices exclude VAT. Your final price is confirmed in your quote.

See how it works

See how you assemble your QMS

Watch how a quality system is assembled from only the modules you need.

1:25 · Build your own QMSWatch all guides

Simple & Predictable

How pricing works

Three components, one predictable monthly invoice.

1

Choose your plan

Foundation (up to 10 users), Growth (up to 50) or Enterprise (unlimited), at a flat monthly fee.

2

Core QMS required

Every paid plan requires the Core QMS base at €499/mo, with 16 essential modules.

3

Add module bundles

Pick only the bundles you need. Each one adds a set of specialized modules (€79–€349/mo each).

=

Your monthly total

Plan fee (flat, users included) + Core QMS (€499) + Σ bundle prices = monthly total, excl. VAT

Add-Ons

Service add-ons

Add storage, single sign-on, API access, backup and disaster recovery, and priority support as you need them.

Extra Storage (+50 GB)

Additional cloud storage for documents, records and attachments (per 50 GB block)

€29/mo

Single Sign-On (OpenID Connect)

Sign in with your OpenID Connect identity provider; two-factor rules still apply. Growth and Enterprise. SAML 2.0 is not available yet.

€99/mo

REST API Access

REST API (v1) with company-scoped API keys and signed webhooks for key events. Growth and Enterprise.

€79/mo

Automated Backups & DR

Encrypted database backups every 6 hours to separate off-site storage, nightly encrypted file backups and weekly automated restore tests

€49/mo

Priority Support

Dedicated support engineer, 4-hour response target, priority bug fixes and monthly check-in calls. Growth and Enterprise.

€199/mo

Custom Integration

Custom integration work on our REST API: tell us what you need to connect

Contact us

Standard Features

Included with every plan

All plans include essential capabilities for regulated quality management.

E-Signatures

Part 11-ready electronic signatures: password re-authentication, signature meaning, reason, timestamp, IP and file hash

Built for your frameworks

Built around ISO 13485, EU MDR and FDA QMSR. EU AI Act modules are available as an Enterprise bundle.

EU Data Residency

Hosted in the EU and operated by MoniDose. We act as your GDPR processor; a data processing agreement is available on request.

Guided onboarding

Guided onboarding and data import tools. Larger migrations are quoted up front.

Find Your Regulatory Requirements

Tell us about your product and target markets. We'll identify the regulations, standards, and modules your organization needs.

Open Regulatory Guide

Plan Details

Feature comparison

See exactly what's included in each plan. Prices exclude VAT. Your final price is confirmed in your quote.

Feature14-Day TrialFoundationGrowthEnterprise
Core QMS (required, €499/mo)
Document Control
CAPA Management
Change Control, Deviations, Non-conformances
Electronic Signatures
SOP Template Library
Add-on bundles
Add-on bundles included in planNoneUp to 3Up to 6All
Audits & QMS GovernanceAdd-onAdd-onAdd-on
Risk & VigilanceAdd-onAdd-onAdd-on
Design & DevelopmentAdd-onAdd-onAdd-on
Suppliers & PurchasingAdd-onAdd-onAdd-on
Clinical & Post-MarketAdd-onAdd-onAdd-on
EU AI Act ComplianceAdd-on
Compliance
Part 11-ready e-signatures
Tamper-evident audit trail
ISO 13485 SOP templates
Customer Validation Guide (IQ/OQ/PQ templates, under NDA)
Configurable approval workflows (2, 3 or 4 signatures)
Support & Access
Email support
Priority Support (4-hour response)Add-on €199Add-on €199
REST APIAdd-on €79Add-on €79
Single sign-on (OpenID Connect)Add-on €99Add-on €99

FAQ

Common questions

Everything you need to know about our pricing and plans

Your monthly total is a flat plan fee plus the required Core QMS base plus the module bundles you choose. Plan fees are EUR 49 (Foundation, up to 10 users included), EUR 79 (Growth, up to 50 users) and EUR 129 (Enterprise, unlimited users). The Core QMS is EUR 499 per month and is required on every paid plan. You then add only the bundles you need, from EUR 79 to EUR 349 per month each, across 130+ modules in 14 bundles. The smallest paid setup is therefore EUR 548 per month. Prices exclude VAT. Your final price is confirmed in your quote.

The 14-day trial gives you the Core QMS for up to 3 users with 1 GB of storage. No credit card is needed. Want to evaluate a specific bundle, such as Risk or Regulatory Affairs? Tell us in your request. When you choose a plan, your trial workspace becomes your live workspace, so nothing has to be re-entered.

Send a short trial request at /contact. We confirm your email, review the request, activate your workspace and send your login, usually within one business day. No credit card and no obligation. If you prefer a guided look first, book a 30-minute demo at /demo.

Yes. Organizations that come to MoniDoseQMS through one of our partner organizations can get 2 months of free use with a partner code, entered when you set up your account. If you think your organization qualifies, contact us at info@monidoseqms.com to request a partner code.

You can start working in the Core QMS as soon as your workspace is active. Plan a few weeks for a full rollout with data import, roles, workflows and training, depending on scope. Adding a bundle later does not require a migration.

Yes. You can move to a larger plan or add bundles and add-ons at any time. Your data, configuration and audit trail stay in the same workspace.

The Core QMS (EUR 499 per month, required on every paid plan) is the foundation of MoniDoseQMS. It has 16 modules: document management hub, document control, document signing, electronic signatures, SOP template library, change control, deviations, non-conformances, CAPA, preventive actions, notes, record archival, quality KPIs, cost of quality, SPC charts and performance evaluations. Every other bundle builds on it, so all bundles share one document control, CAPA, audit trail and e-signature backbone instead of disconnected point tools.

MoniDoseQMS groups its 130+ modules into 14 bundles: the Core QMS plus 13 add-on bundles such as Risk & Vigilance, Audits & QMS Governance, Design & Development, Device Verification Tests, Process & Operational Validations, Production & Operations and Regulatory Affairs. Each add-on bundle costs between EUR 79 and EUR 349 per month and includes every module in it. Foundation can include up to 3 add-on bundles, Growth up to 6, and Enterprise all of them. The EU AI Act bundle requires the Enterprise plan.

MoniDoseQMS is built to support ISO 13485, EU MDR, FDA QMSR and 21 CFR Part 11 workflows. As with any eQMS, you validate it for your intended use. To support that, paid customers get our Customer Validation Guide under NDA at no extra cost: IQ/OQ/PQ protocol templates and traceability guidance. It is currently a draft edition, and our team answers questions while you execute your validation.

Every plan includes email support from our team and access to the user guide. If you need faster answers, the Priority Support add-on (EUR 199 per month, Growth and Enterprise) adds a dedicated support engineer, a 4-hour response target, priority bug fixes and monthly check-in calls.

REST API access (EUR 79 per month) and single sign-on via OpenID Connect (EUR 99 per month) are add-ons for Growth and Enterprise plans. Other add-ons are Extra Storage (+50 GB) at EUR 29 per month, Automated Backups & DR at EUR 49 per month and Priority Support at EUR 199 per month.

Customer data is hosted in the EU and operated by MoniDose. Connections use TLS 1.2 or higher, database backups are AES-256 encrypted every 6 hours and copied off-site, tenants are separated by PostgreSQL row-level security on 200+ tables, and every change is recorded in a tamper-evident, SHA-256 hash-chained audit trail. MoniDose does not currently hold ISO 27001 or SOC 2 certification. See our Security page, or ask for our controls documentation under NDA.

Yes. Most modules export to CSV, selected reports also export to Excel or PDF, and a full export of your data is available. After termination you have 30 days to export your data. You can cancel at the end of any paid period.

The Data Import wizard brings existing records and documents in. Imported legacy records arrive as drafts and must be re-approved in MoniDoseQMS, so every imported record has a fresh, attributable approval. That is good for ALCOA+ and for your auditors.

By invoice, in EUR, excluding VAT. Monthly and annual billing cost the same, there is no annual discount. We give at least 30 days' notice of any fee change, and a cancellation takes effect at the end of the paid period. Fees for invoiced periods are non-refundable.

Pick your team size and bundles and the estimator shows the plan that fits and your monthly total (plan fee, Core QMS and bundles) excluding VAT. It is an estimate. Your final price is confirmed in your quote.

No. Consultants join through the Expert Network, a separate application from customer plans. Once approved, you get an expert workspace with a directory listing, consent-gated access to the clients who engage you, and built-in time tracking and invoicing, with no per-client seat to purchase. Apply at monidoseqms.com/for-experts/apply.

Are you a regulatory or quality consultant?

Listing in the Expert Network is a separate application — get discovered, work inside clients' live QMS with consent, and serve unlimited clients from one workspace.

Notified body? See the notified body workspace. Early-stage startup? Try the Startup Launchpad.

Get Started

Request your 14-day trial

Try the Core QMS with your own team for 14 days. No credit card and no commitment. We activate your workspace after a short review, usually within one business day.

Have a partner code? Organizations unlock 2 months free — just ask us for one.