Manufacturers, experts, and notified bodies
under one roof.
MoniDoseQMS unites everyone in the regulatory journey on one platform — the companies bringing medical products to market, the regulatory experts they hire, and (in development) the notified bodies that certify them. One source of truth, full traceability, no fragmented tools — built on a 130+ module eQMS for EU MDR, FDA QMSR, ISO 13485, and the EU AI Act.
Regulatory Compliance
One platform, three sides
The whole regulatory journey, under one roof
Compliance today is split across disconnected tools and disconnected parties. MoniDoseQMS brings the manufacturer, the expert, and the notified body into one connected quality system — so everything is traceable, monitorable, and managed in one place instead of fragmented across a dozen tools.
For companies
Bring your product to market
Startups · Manufacturers · Labs · Health-tech · Medical companies
Run your entire quality system in one place — 130+ integrated modules across document control, risk, CAPA, design, clinical, and post-market, with EU MDR, FDA QMSR, ISO 13485, and EU AI Act built in.
Explore the platformFor experts
Get hired for the work that's needed
Regulatory & quality consultants · RA/QA experts
Get discovered by regulated companies, work inside their real QMS with their consent, and leave advice they can act on — all billed from one workspace. Companies find the expertise they need and pay for the job that needs doing.
Join the expert networkFor notified bodies
Where notified bodies assess and certify
Notified bodies · Conformity assessment bodies
A dedicated workspace where a designated notified body runs its own assessments inside a manufacturer's QMS under recorded consent — raising findings, signing its own certificates, and managing surveillance. MoniDoseQMS provides the software; the notified body holds the authority and makes every decision.
Learn about the workspaceOne system. Full traceability. No fragmented tools. When the manufacturer, the expert, and the notified body all work in the same quality system, nothing falls through the gaps between tools — and every record has one home.
MoniDoseQMS is a software platform, not a notified body or conformity assessment body. It does not perform, review, approve, or issue conformity assessments, certificates, or CE marking. Conformity assessment and certification are carried out solely by the designated notified body and the manufacturer, who hold all authority and responsibility for those decisions. MoniDoseQMS only provides the software that records their work.
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.
Everything in one platform
At the heart of the ecosystem is a full eQMS — 130+ modules across 16 categories that replace disconnected tools with a single, integrated quality management system built for regulated industries.
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.
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 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 CoverageGrowing with the ecosystem
We team up with the organisations that build Finland's health-tech scene — so the companies they support can build quality in from day one.
See all partnerships
Business Tampere
The economic development agency of the Tampere city region — home to one of Finland's strongest health-technology ecosystems.
Together with Business Tampere we run a free pilot programme for health-tech companies in its ecosystem: try the full MoniDoseQMS platform on a real, no-obligation pilot and see how it fits your quality work before spending a euro.
- Under a year old? Your startup gets MoniDoseQMS free for 6 months.
- Established company? You get a free 60-day pilot.
Are you an expert? Grow your practice on MoniDoseQMS
We're the first eQMS with a consulting network built in. Get discovered by regulated companies, work inside their real quality system with their consent, and run every client from a single workspace — advising, tracking hours and invoicing without the busywork.
Browse the expert directoryServe unlimited clients
Run every engagement, across every customer, from one workspace.
Work inside their real QMS
Consent-gated access to your client's live quality system — they choose your level, from read-only to suggesting changes they approve.
Advise & get paid
Leave recommendations, track hours and invoice — all in one place.
Built-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? And why should the experts they hire and the notified bodies that certify them each live in a different system, emailing documents back and forth?
That question led to MoniDoseQMS — a comprehensive eQMS with 130+ integrated modules, grown into a regulatory ecosystem that brings the manufacturer, the expert, and the notified body (in development) under one roof. Today, we help companies achieve compliance with EU MDR, FDA QMSR, ISO 13485, and the EU AI Act.
The latest from MoniDoseQMS
Product updates, new tools, and deep dives into every part of the platform — a fresh spotlight every day.
Ready to bring your quality journey under one roof?
Start your 14-day free trial — no credit card required. Full platform access with all 130+ modules.