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Pricing

Transparent Pricing for Regulated Industries

Pay for what you use. Core QMS + per-user pricing + only the module categories you need.

No setup fees
No implementation fees
14-day free trial

Free Trial

Try it free

Explore the full platform risk-free. All modules accessible for 14 days — no credit card required.

Free

14 days

No credit card required

Start Free Trial
  • Up to 3 users
  • All modules accessible
  • 1 GB storage
  • No credit card required
  • Full audit trail
  • Cloud-hosted (EU data center)

Foundation

Perfect for startups

For startups and small teams building their first compliant QMS infrastructure.

€49

/per user / month

+ Core QMS (499/mo) + category add-ons

Get Started
  • Up to 10 users
  • Core QMS included
  • Up to 3 add-on categories
  • 5 GB storage
  • 21 CFR Part 11 e-signatures
  • Email support (business hours)
  • Cloud-hosted (EU data center)
Most Popular

Growth

Best for scaling teams

For expanding companies ready to streamline operations and accelerate regulatory approval.

€79

/per user / month

+ Core QMS (499/mo) + category add-ons

Get Started
  • Up to 50 users
  • Core QMS included
  • Up to 6 add-on categories
  • 25 GB storage
  • Custom workflows
  • Priority email & chat support
  • Self-service validation docs

Enterprise

Full platform access

For established manufacturers needing full platform access and global regulatory coverage.

€129

/per user / month

+ Core QMS (499/mo) + category add-ons

Get Started
  • Unlimited users
  • All 130+ modules across 16 categories
  • 100 GB storage
  • SSO / SAML integration
  • REST API access
  • Dedicated account manager
  • 24/7 phone support (4h SLA)
  • Cloud (dedicated) or on-premise

Simple & Predictable

How pricing works

Three components, one predictable monthly invoice.

1

Choose your plan

Foundation, Growth, or Enterprise based on your team size and needs.

2

Core QMS included

Every paid plan includes the Core QMS platform at €499/mo with 14 essential modules.

3

Add module categories

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

=

Your monthly total

(Per-User × Users) + Core QMS (€499) + Σ Category Prices = Monthly Total

Examples

Real-world scenarios

See how pricing works for teams like yours.

MedTech Startup

Foundation plan

Early-stage device company building first QMS

5 users × €49/mo€245
Core QMS (required)€499
Risk & Safety€199
Design & Development€149
Monthly total€1,092/mo

Competitor range: €2,500–€4,500/mo with competitors

Scaling Manufacturer

Growth plan

Growing company with multi-market ambitions

25 users × €79/mo€1,975
Core QMS (required)€499
Risk & Safety€199
Audit & Compliance€199
Manufacturing & Production€199
Products & Materials€179
Supplier & Distribution€129
Monthly total€3,379/mo

Competitor range: €6,000–€12,000/mo with competitors

Enterprise MedDevice

Enterprise plan

Global manufacturer with full regulatory coverage

100 users × €129/mo€12,900
All 16 categories included€3,384
Monthly total€16,284/mo

Competitor range: €25,000–€50,000/mo with competitors

Add-Ons

Premium add-ons

Extend your platform with dedicated infrastructure, validation, and integrations.

Extra Storage (+50 GB)

Additional cloud storage for documents, records, and attachments

€29/mo

SSO / SAML Integration

Single sign-on with your identity provider (Okta, Azure AD, etc.)

€99/mo

REST API Access

Programmatic access to all platform data and workflows

€79/mo

Automated Backups & DR

Automated disaster recovery with cross-region backup replication

€49/mo

Priority Support

Dedicated support engineer with 4-hour SLA response time

€199/mo

Custom Integration

Tailored integrations with your existing ERP, PLM, or LIMS systems

Contact Us

Standard Features

Included with every plan

All plans include essential capabilities for regulated quality management.

E-Signatures

21 CFR Part 11 compliant electronic signatures on all paid plans

Compliance Frameworks

Pre-configured for EU MDR, FDA QMSR, ISO 13485, and EU AI Act

EU Data Residency

Data hosted in certified EU data centers with full GDPR compliance

Implementation Support

Onboarding, training, and data migration support included

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

FeatureFree TrialFoundationGrowthEnterprise
Core Modules
Document Control
CAPA Management
Audit Management
Training & Competency
Nonconformance Handling
Supplier Quality Management
Add-onAdd-on
Post-Market Surveillance
Add-onAdd-on
Design & Development
Add-onAdd-on
Risk Management (ISO 14971)
Add-onAdd-on
All 130+ Modules14-day access
Compliance
21 CFR Part 11 E-Signatures
Audit Trail
ISO 13485 Framework
EU MDR / FDA QMSR Templates
EU AI Act Module
Add-onAdd-on
Support & Deployment
Email SupportCommunityBusiness hoursPriority24/7
Dedicated Account Manager
REST API Access
SSO / SAML 2.0
Custom Workflows
IQ/OQ/PQ ValidationSelf-serviceIncluded
On-Premise Option

FAQ

Common questions

Everything you need to know about our pricing and plans

MoniDoseQMS uses transparent, modular pricing with no hidden fees. Your monthly total is calculated as: (Per-User Price × Number of Users) + Core QMS (€499/mo) + Selected Category Add-Ons. Per-user rates are €49/mo for Foundation, €79/mo for Growth, and €129/mo for Enterprise. You only pay for the module categories you need — choose from 16 categories with 130+ modules total, priced between €79 and €349 per month per category. There are no setup fees and no implementation fees.

The 14-day free trial gives you full platform access with up to 3 users and 1 GB of storage — no credit card required. You get access to the complete Core QMS and can explore all 16 module categories to see exactly how MoniDoseQMS fits your workflow. At the end of the trial, simply choose a plan and your data carries over seamlessly.

Start your 14-day free trial directly from our website — no credit card, no sales call required. Within minutes you'll have access to the full platform with up to 3 users. Explore Core QMS and all module categories at your own pace. When you're ready to go live, pick the plan that fits your team size and add the categories you need.

Most teams are up and running within days, not months. Since MoniDoseQMS is cloud-based with no setup or implementation fees, you can start using Core QMS immediately. Adding module categories is instant. Full rollouts including data migration, user training, and process configuration typically take 2–6 weeks depending on scope — our implementation team guides you through every step at no extra cost.

Yes, you can upgrade at any time. Move from Foundation to Growth or Enterprise seamlessly — your data, configurations, and complete audit trails transfer automatically with zero downtime. You can also add module categories or premium add-ons whenever your needs evolve. Many customers start with a few categories and expand as they grow.

Core QMS (€499/mo, included in every paid plan) is the foundation of MoniDoseQMS. It provides document control, audit trail, user management, electronic signatures, change control, and the compliance engine that powers everything else. All module categories build on Core QMS, so it ensures a unified, validated quality management system rather than disconnected point solutions.

MoniDoseQMS organizes its 130+ modules into 16 categories such as Risk Management, CAPA, Training, Supplier Quality, Design Controls, and more. Each category is priced between €79 and €349 per month and includes all modules within it. Foundation plans can add up to 3 categories, Growth up to 6, and Enterprise gets access to all 16. This lets you build a QMS tailored exactly to your regulatory and operational needs.

Yes. MoniDoseQMS is designed and validated for ISO 13485:2016, EU MDR 2017/745, FDA QMSR, 21 CFR Part 11, IEC 62304, IEC 62366-1, and EU AI Act compliance requirements. Validation documentation, IQ/OQ/PQ protocols, and compliance mapping are included at no additional cost. The platform maintains a complete audit trail and enforces electronic signature requirements automatically.

Foundation includes email support with a 24-hour response time and access to our knowledge base. Growth adds priority email and chat support with an 8-hour SLA, plus onboarding assistance. Enterprise includes dedicated account management, 24/7 phone support with a 4-hour SLA, and custom training. All plans include implementation guidance and access to platform documentation.

API access and SSO are available as premium add-ons: API Access at €79/mo and SSO at €99/mo. Growth and Enterprise plans can add these directly. Additional premium add-ons include Extra Storage (+50 GB) at €29/mo, Automated Backups at €49/mo, and Priority Support at €199/mo. Enterprise plans include SSO and API access by default.

All data is encrypted at rest (AES-256) and in transit (TLS 1.3). Data is hosted in certified EU data centers with full GDPR compliance, tenant isolation, and regular third-party security assessments. Every plan includes a complete audit trail with tamper-proof logging. Enterprise plans add advanced security features including SSO, automated backups, and dedicated infrastructure options.

Our interactive calculator helps you estimate your monthly cost and potential savings. Enter your team size, select the module categories you need, and choose any premium add-ons. The calculator applies the pricing formula — (Per-User Price × Users) + Core QMS (€499/mo) + Selected Categories + Add-Ons — and shows your total monthly investment alongside estimated savings from consolidating multiple point solutions into one platform.

Get Started

Start your 14-day free trial

No credit card required. Explore the full platform with your team and see why regulated companies choose MoniDoseQMS.