Compliance Built In, Not Bolted On
Every module maps to specific regulatory requirements. Audit trails, electronic signatures, and tenant isolation are the foundation everything is built on — not added on top.
Below you will find detailed information about our regulatory coverage, validation approach, and data integrity assurance.
Regulatory Frameworks
Primary Regulations Supported
Purpose-built modules for each major regulatory framework, with specific workflows tailored to each requirement.
European Union
EU MDR 2017/745
Full support for Medical Device Regulation requirements including technical documentation (Annex II/III), post-market surveillance (Articles 83-86), vigilance reporting (Articles 87-92), and UDI management.
Key Modules
United States
FDA QMSR
Aligned with the new Quality Management System Regulation harmonizing FDA requirements with ISO 13485. Covers design controls, production controls, CAPA, and management responsibility.
Key Modules
International
ISO 13485:2016
Complete quality management system aligned with every clause of ISO 13485. From management responsibility through resource management, product realization, and measurement analysis.
Key Modules
European Union
EU AI Act
The only eQMS platform with dedicated modules for EU AI Act compliance as it applies to medical devices. Manage conformity assessments, risk management, and post-market monitoring for AI/ML components.
Key Modules
United States
21 CFR Part 11
Full compliance with FDA requirements for electronic records and electronic signatures. Audit trails, access controls, signature manifestations, and system validation support.
Key Modules
International
MDSAP
Support for the Medical Device Single Audit Program covering requirements from the US, Canada, Brazil, Australia, and Japan in a single audit framework.
Key Modules
Validation & Data Integrity
Validated for Regulated Environments
Has this software been validated for use in a regulated environment? Here is our approach.
Computer System Validation (CSV)
Risk-based CSV approach aligned with GAMP 5. We provide validation documentation covering Installation Qualification, Operational Qualification, and Performance Qualification. Our approach defines clear boundaries between vendor responsibility (software validation) and customer responsibility (process validation in your environment).
21 CFR Part 11 Compliance
Every requirement addressed: unique user identification, electronic signatures with meaning manifestations, authority checks, audit trails capturing all CRUD operations, record protection against unauthorized modification, system access controls with session management, and closed system controls.
ALCOA+ Data Integrity
All records are Attributable (linked to a user), Legible (clearly displayed), Contemporaneous (timestamped at creation), Original (source record maintained), and Accurate (validated input). Plus: Complete (no gaps), Consistent (sequenced), Enduring (durable storage), and Available (retrievable on demand).
IQ/OQ/PQ Documentation
Installation Qualification confirms correct deployment. Operational Qualification verifies features work as specified. Performance Qualification confirms the system performs in your operational environment. Documentation packages available for all plans, with dedicated validation support for Enterprise customers.
Standards Coverage
Applicable Standards
Comprehensive coverage of international standards for medical device quality management.
Our Compliance Philosophy
Compliance is not a feature — it is the foundation. Every record in MoniDoseQMS is automatically audit-trailed. Every approval captures an electronic signature. Every module cross-references related records for full traceability. We do not offer a “compliance add-on” because compliance cannot be bolted on after the fact.