130+ Modules, 16 Categories
Every module is connected. Full traceability between records, audit trails on every action, and electronic signatures built in from day one.
Request Module DetailsQuality 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
Products & Materials
Product master data, bills of materials, inventory, and material safety documentation
Reporting & Analytics
Business intelligence and reporting
System Administration
System configuration and administration