Quality, Regulation and Compliance
MoniDose is being developed as a Class I medical device under EU MDR 2017/745. We manage quality through our MoniDoseQMS platform, putting patient safety first.
EU Medical Device Regulation (MDR)
MoniDose is being developed as a Class I medical device (with software) under EU MDR 2017/745. As a Class I device, MoniDose follows the self-declaration route in accordance with MDR Article 52(7) — no Notified Body is required. The manufacturer prepares the technical documentation, declares conformity, and registers the device with the competent authority. MoniDose is not yet registered; registration with Fimea is planned as part of our regulatory roadmap.
Key Facts
EU MDR 2017/745
Class I (with software)
Self-declaration in accordance with MDR Article 52(7) — No notified body
Not yet registered — registration planned with Fimea
Regulatory Strategy
Our regulatory strategy covers the key pillars required for Class I MDR compliance
Technical Documentation
Complete design dossier including device description, intended purpose, design and manufacturing information, and verification & validation evidence per MDR Annex II/III.
Risk Management (ISO 14971)
Systematic hazard identification, risk estimation, risk control, and residual risk evaluation throughout the entire product lifecycle.
Post-Market Surveillance & UDI
PMS plan, vigilance reporting, periodic safety update reports, and Unique Device Identification (UDI) assignment per MDR requirements.
Standards and Certifications
MoniDose is developed in alignment with these internationally recognized standards for medical device quality and safety
ISO 13485:2016
Quality management system for medical devices
Framework for establishing and maintaining a QMS specific to medical device design, development, and production.
ISO 14971:2019
Risk management for medical devices
Standard for identifying hazards, estimating and evaluating risks, controlling risks, and monitoring effectiveness.
IEC 62304:2006+A1:2015
Medical device software lifecycle
Standard for software development lifecycle processes including planning, requirements, architecture, and maintenance.
EU MDR 2017/745
European Medical Device Regulation
The EU regulation governing safety, performance, and market access for all medical devices sold in Europe.
We Use MoniDoseQMS
MoniDoseQMS is our electronic quality management system. We use it to manage quality processes, maintain MDR compliance, and keep everything organized in one place
Document Management
Version control, approval workflows, and controlled distribution of quality documents and SOPs.
CAPA
Corrective and Preventive Actions tracking with root cause analysis and effectiveness verification.
Risk Management
Risk register with ISO 14971 integration, hazard analysis, and residual risk evaluation.
Nonconformance Handling
NC reporting, investigation workflows, disposition decisions, and trend analysis.
Why Compliance Matters
Every regulation and standard exists to protect the patient. Our commitment to compliance is driven by a responsibility to deliver safe medical technology
Safe by Design
Risk management is integrated into every stage of development, ensuring hazards are identified and controlled from the start.
Full Traceability
Every design decision, change, and test result is documented, providing a complete audit trail from concept to market.
Continuous Improvement
Post-market surveillance and CAPA processes drive ongoing improvements throughout the product lifecycle.
OWASP Security Audited
This website has been audited against the OWASP Top 10 (2021) security framework — the global standard for web application security. As a medical device company, we hold our digital infrastructure to the same rigorous standards as our physical products.
Input Protection
All user inputs are validated and sanitized before processing.
Security Headers
Industry-standard security headers enforced on all responses.
Access Control
Multi-layered request validation and threat detection.
Encryption
Industry-standard encryption for all sensitive data. HTTPS enforced.
Dependency Security
Continuous monitoring and regular patching of all dependencies.
Data Integrity
Server-side validation on all form submissions. No unverified third-party resources.
Last audited: March 2026 · OWASP Top 10 (2021) · 18 security controls verified
Explore the MoniDoseQMS Platform
Discover how MoniDoseQMS supports MDR compliance, quality management, and continuous improvement — all in one cloud-based platform.