Medical Device Suite
The Medical Device Software Suite streamlines the management of ISO 14971 risks and CEI 62366 usability, offering modular programs that enhance collaboration among Regulatory Affairs and Design teams. It eliminates duplicate entries, ensures audit readiness, and maintains consistency across critical reports, facilitating effective risk analysis and compliance with international standards.
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Top Medical Device Suite Features
- Modular software architecture
- Audit compliance assurance
- Traceability tracking features
- Risk analysis automation
- Usability testing integration
- FMEA process support
- Consistency in data sharing
- Centralized documentation management
- Validation file generation
- Cross-regulatory compliance
- Real-time data updates
- Usability report coherence
- Customizable module selection
- Streamlined design processes
- Multi-regional compliance support
- User-friendly interface
- Data redundancy elimination
- Comprehensive risk management
- Integrated design workflows
- Historical data tracking
