Built for Regulated
Industries
From medical devices and pharmaceuticals to digital health and contract manufacturing — MoniDoseQMS provides industry-specific compliance frameworks for every regulated sector.
Request AccessMedical Devices
Full ISO 13485, EU MDR, and FDA coverage for Class I, II, and III devices. Design controls, risk management, clinical evaluation, and post-market surveillance in one platform.
In Vitro Diagnostics
EU IVDR compliance, performance evaluation studies, clinical performance studies, and common specifications tracking for diagnostic manufacturers.
Pharmaceuticals
GMP/GDP compliance, batch record management, deviation handling, environmental monitoring, and supplier quality management for drug manufacturers.
Biotechnology
R&D documentation, design development, lab sample management, software validation, and clinical investigation support for biotech companies.
Combination Products
Cross-functional document control and integrated risk management for products spanning both drug and device regulatory frameworks.
Digital Health & SaMD
Software as Medical Device lifecycle management, IEC 62304 compliance, cybersecurity assessment, and EU AI Act governance for digital health companies.
AI/ML-Enabled Devices
12 dedicated EU AI Act compliance modules. AI system inventory, risk assessment, data governance, transparency, and post-market monitoring.
Contract Manufacturing
Multi-client quality management, supplier qualification, process validation, equipment calibration, and batch records for CMOs.
Contract Research
Clinical investigation management, regulatory submissions, training records, and document control for multi-study CRO environments.
Laboratory Services
Lab sample tracking, method validation, equipment calibration, environmental monitoring, and competency management for regulated laboratories.
Cosmetics & Personal Care
Product safety assessments, GMP compliance (ISO 22716), complaint handling, and supplier quality for cosmetics and personal care manufacturers.
Food & Beverage
HACCP/FSSC 22000 quality management, supplier audits, non-conformance handling, and training records for food and beverage companies.
Veterinary Devices
Similar regulatory structure to human medical devices with market-specific requirements. Full medical device module set available.