Quality Management,
Simplified.
The all-in-one eQMS platform for regulated industries. 130+ integrated modules across 16 categories. Full compliance with EU MDR, FDA QMSR, ISO 13485, and EU AI Act — all in one unified platform.
Regulatory Compliance
Core Capabilities
Everything in one platform
130+ modules across 16 categories — replace disconnected tools with a single, integrated quality management system built for regulated industries.
How It Works
Up and running in days, not months
Get started quickly with a guided setup that adapts to your regulatory requirements and existing processes.
Configure
Set up your quality system in minutes. Import existing documents, configure workflows, and define your regulatory scope. No coding required.
Operate
Your team manages documents, CAPAs, audits, and training in one place. Automated notifications keep everyone aligned and on schedule.
Comply
Generate audit-ready reports instantly. Demonstrate compliance to ISO 13485, EU MDR, FDA QMSR, and more with full traceability.
Why Trust Us
Why trust a newer platform with your compliance data?
Regulated industries demand evidence, not promises. Here is what makes MoniDoseQMS different.
Built by Quality Professionals
Founded by professionals who have lived through regulatory audits. Every workflow is designed to pass scrutiny.
Regulatory-First Design
Every feature built against actual requirements from ISO 13485, FDA 21 CFR Part 11, EU MDR, and more.
EU Data Residency
Data hosted in the EU on enterprise-grade infrastructure. Full GDPR compliance with data processing agreements.
European Origin
Founded and operated from Finland. EU company, EU data residency, EU regulatory focus.
Full Data Portability
Export your data at any time, in standard formats. No vendor lock-in, no multi-year contracts required.
Validation Documentation
Computer System Validation (IQ/OQ/PQ) documentation available. Risk-based CSV approach for regulated environments.
EU AI Act Compliance Modules
MoniDoseQMS is the only eQMS platform with dedicated modules for EU AI Act compliance as it applies to medical devices. As AI-embedded medical devices face new regulatory obligations, quality teams need purpose-built tools to manage conformity assessments, risk management, and post-market monitoring for AI/ML components.
Learn About Our Compliance CoverageBuilt-In Compliance
Regulatory compliance, automated
Pre-configured frameworks for every major medical device regulation. Maintain continuous audit readiness without compliance spreadsheets.
Additional Standards
Plus support for ISO 10993, ISO 11607, ISO 11135, and country-specific requirements for 30+ markets.
Built from Real Experience
MoniDoseQMS was born from firsthand experience with the challenges of medical device quality management. Our founders, having worked in the medical device industry, understood the pain of managing multiple disconnected tools, struggling with compliance documentation, and spending countless hours on administrative tasks.
We asked ourselves: why should medical device companies need 14+ separate software tools to manage their QMS? Why can't there be one integrated platform that handles everything from document control to post-market surveillance?
That question led to the creation of MoniDoseQMS — a comprehensive platform with 130+ integrated modules designed specifically for regulated industries. Today, we help companies achieve compliance with EU MDR, FDA QMSR, ISO 13485, and the EU AI Act.
Ready to simplify your quality management?
Start your 14-day free trial — no credit card required. Full platform access with all 130+ modules.