Description
Key Features and Benefits
- Design Control & Risk Management – Maintains traceability throughout product development.
- Regulatory Compliance – Meets FDA, ISO 13485, and EU MDR requirements with automated documentation.
- Document & Change Management – Centralized control over SOPs, revisions, and design outputs.
- CAPA & Nonconformance Management – Identifies, tracks, and resolves quality issues.
- Audit & Training Management – Streamlines audits, training, and compliance tracking.
- Supplier & Complaint Management – Ensures vendor quality and proper complaint handling.
- Analytics & Reporting – Provides insights into compliance, risk, and quality metrics.
Key Differentiators
- Medical Device-Specific QMS – Tailored exclusively for medtech companies.
- Automated Compliance Tracking – Helps companies adhere to regulatory requirements seamlessly.
- User-Friendly Interface – Simplifies document management and workflow automation.
- Industry-Specific Templates – Reduces setup time with preconfigured compliance tools.
