Integrated Module Categories
A comprehensive ecosystem of interconnected modules covering every aspect of medical device quality management.
Quality Management Core
Foundation of your quality system with document control, CAPA, audits, and more
Clinical & Post-Market
Clinical evaluation and post-market surveillance capabilities
EU AI Act Compliance
AI/ML regulatory compliance for AI-enabled medical devices
Design & Development
Complete design control for product development
Manufacturing & Production
Manufacturing execution and production control
Supply Chain & Suppliers
Supplier management and supply chain control
Regulatory Affairs
Regulatory submissions and compliance management
Training & Competency
Personnel training and competency management
Risk Management
ISO 14971 risk management throughout product lifecycle
Testing & Inspection
Quality testing and inspection management
Electronic Records
21 CFR Part 11 compliant electronic records
Reporting & Analytics
Business intelligence and reporting
System Administration
System configuration and administration
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