Comprehensive
QMS Coverage
Everything you need to manage the complete medical device lifecycle—from design control to post-market surveillance.
Request a DemoQuality Management Core
CAPA, non-conformance, complaints, audits, and change control.
Clinical & Post-Market
Clinical evaluation, PMS, PMCF, PSUR, and vigilance.
EU AI Act Compliance
Complete EU AI Act compliance for AI-enabled medical devices.
Design & Development
Complete design control per FDA and ISO 13485.
Manufacturing & Production
Manufacturing control, batch management, and process validation.
Supply Chain & Suppliers
Supplier quality and inventory management.
Regulatory Affairs
Regulatory submission and documentation management.
Training & Competency
Personnel qualification and training management.
Risk Management
ISO 14971-compliant risk management.
Testing & Inspection
Testing and validation documentation.
Electronic Records
21 CFR Part 11 compliant records and signatures.
Reporting & Analytics
Real-time dashboards and analytics.
System Administration
System configuration and administration.
See the Full Feature Set
Contact us for a detailed walkthrough of our comprehensive QMS platform tailored to your specific regulatory requirements.
Regulatory frameworks supported