One Platform.
Total Control.
Enterprise-grade QMS covering the complete medical device lifecycle. Full compliance with EU MDR, FDA 21 CFR 820, ISO 13485, and EU AI Act—all in one unified platform.
Regulatory Compliance
Unified Quality Management
Everything in One Platform
Document control, risk management, CAPA, training, and post-market surveillance—unified under a single system of record.
Document Control
Centralized document management with version control, e-signatures, and audit trails
Design Control
End-to-end design lifecycle with traceability from inputs to validation
Risk Management
ISO 14971 compliant hazard analysis, risk matrices, and control tracking
CAPA
Streamlined corrective actions with root cause analysis and effectiveness checks
Supplier Quality
Vendor qualification, audits, scorecards, and quality agreement management
Training
Skills matrix, competency tracking, and automated training compliance
Audit Management
Internal and external audit planning with findings and closure tracking
Post-Market
Complaints, vigilance reporting, PMS plans, and PSUR generation
One connected platform. Zero integration headaches.
Explore All FeaturesBuilt-In Compliance
Regulatory Requirements. Automated.
Pre-configured frameworks for EU MDR, FDA 21 CFR 820, ISO 13485, and more. Maintain continuous audit readiness without manual tracking or compliance spreadsheets.
Additional Standards Supported
Plus support for IEC 60601, ISO 10993, MDSAP, and more.
Complete Integration
One Source of Truth.
Eliminate data silos and manual handoffs. Every module connects natively—sharing data, triggering workflows, and maintaining full traceability across your quality system.
Document & Design
8 modules
Risk & Quality
7 modules
Regulatory & Clinical
7 modules
Post-Market
7 modules
Unified Platform
One Platform, Complete Coverage
Managing quality with multiple disconnected tools creates inefficiencies and compliance risks. MoniDoseQMS consolidates everything into one integrated platform.
See How MoniDoseQMS Can Help
Every organization has unique needs. Contact us for a personalized assessment of how MoniDoseQMS can streamline your quality operations and reduce costs.
One Platform.
Total Control.
Replace your fragmented quality tools with a unified platform. Single source of truth for your entire quality management system.
MoniDoseQMS
Enterprise Quality Platform