Quality Management,
Simplified.
The all-in-one eQMS platform for regulated industries. 130 integrated modules across 13 categories. Full compliance with EU MDR, FDA QMSR, ISO 13485, and EU AI Act — all in one unified platform.
Regulatory Compliance
See it in action
Watch how teams use MoniDoseQMS
Step-by-step video guides — from initial setup to deep dives into every module. Each guide shows exactly how the platform works in a real quality workflow.
Core Capabilities
Everything in one platform
130 modules across 13 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.
From idea to market
One platform for the whole journey
Whether you're a startup taking your first product to market or an established manufacturer consolidating your quality system, MoniDoseQMS grows with you at every stage — from the first idea to post-market surveillance and beyond.
Idea & classification
Figure out your device class and regulatory pathway before you build anything. Use the free Classification Wizard, Regulatory Guide, and Startup Launchpad — no sign-up required.
Try the free toolsBuild your QMS
Stand up an ISO 13485 quality system in minutes. Pick only the modules you need — document control, CAPA, training, and more — with no implementation fee.
See how it worksDesign & develop
Run design controls, risk management (ISO 14971), and software lifecycle (IEC 62304) with built-in traceability from input to verification and validation.
Explore modulesClinical & evidence
Plan clinical evaluations and investigations, document benefit-risk, and build the evidence your notified body or the FDA expects — all linked to your QMS.
Clinical modulesSubmit & go to market
Assemble technical documentation, UDI records, declarations of conformity, and CE marking or FDA submissions — EU MDR, FDA QMSR, and EUDAMED ready.
Compliance coverageScale & stay compliant
Manage manufacturing, suppliers, and training as you grow, and close the loop with post-market surveillance, complaints, vigilance, CAPA, PMCF, and PSUR.
See all modulesStop stitching together spreadsheets and disconnected tools. One validated platform, idea to market — and every audit in between.
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 includes a dedicated EU AI Act module suite for 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 multiple 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.
News & Updates
The latest from MoniDoseQMS
Product updates, new tools, and deep dives into every part of the platform — a fresh spotlight every day.
Ready to simplify your quality management?
Start your 14-day free trial — no credit card required. Full platform access with all 130 modules.