Pricing
Transparent Pricing for Regulated Industries
Pay for what you use. Core QMS + per-user pricing + only the module categories you need.
Free Trial
Try it free
Explore the full platform risk-free. All modules accessible for 14 days — no credit card required.
Free
14 daysNo credit card required
- 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
- 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)
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
- 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
- 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.
Choose your plan
Foundation, Growth, or Enterprise based on your team size and needs.
Core QMS included
Every paid plan includes the Core QMS platform at €499/mo with 14 essential modules.
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
Competitor range: €2,500–€4,500/mo with competitors
Scaling Manufacturer
Growth plan
Growing company with multi-market ambitions
Competitor range: €6,000–€12,000/mo with competitors
Enterprise MedDevice
Enterprise plan
Global manufacturer with full regulatory coverage
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 GuidePlan Details
Feature comparison
See exactly what's included in each plan
| Feature | Free Trial | Foundation | Growth | Enterprise |
|---|---|---|---|---|
| Core Modules | ||||
| Document Control | ||||
| CAPA Management | ||||
| Audit Management | ||||
| Training & Competency | ||||
| Nonconformance Handling | ||||
| Supplier Quality Management | Add-on | Add-on | ||
| Post-Market Surveillance | Add-on | Add-on | ||
| Design & Development | Add-on | Add-on | ||
| Risk Management (ISO 14971) | Add-on | Add-on | ||
| All 130+ Modules | 14-day access | |||
| Compliance | ||||
| 21 CFR Part 11 E-Signatures | ||||
| Audit Trail | ||||
| ISO 13485 Framework | ||||
| EU MDR / FDA QMSR Templates | ||||
| EU AI Act Module | Add-on | Add-on | ||
| Support & Deployment | ||||
| Email Support | Community | Business hours | Priority | 24/7 |
| Dedicated Account Manager | ||||
| REST API Access | ||||
| SSO / SAML 2.0 | ||||
| Custom Workflows | ||||
| IQ/OQ/PQ Validation | Self-service | Included | ||
| 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.