Best QMS for Medical Device Design Control and SaMD
SmartEye is your all-in-one Quality Management System (QMS) solution, purpose-built for medical device design control and Software as a Medical Device (SaMD) compliance. Whether you're developing hardware-based devices or standalone medical software, SmartEye helps you streamline your product lifecycle while staying compliant with global regulatory standards.
SmartEye Quality Management Software (QMS) is ready for your next audit inspection, before you even know it’s happening
Why SmartEye for Design Control and SaMD?
Developing a medical device—especially software-based solutions—requires strict adherence to regulations like FDA 21 CFR Part 820, ISO 13485, and IEC 62304. SmartEye centralizes and automates your design control processes, making it easy to manage :
- Design inputs and outputs
- Risk management and hazard analysis
- Design verification and validation (V&V)
- Design reviews and approvals
- Software development life cycle (SDLC) documentation
S-Cube Technologies with its experience in Quality and Regulatory Affairs has proved to know how to keep your company compliant. It has developed an electronic Quality Management System (eQMS) called SmartEye which will guide you to success with its workflows that are already configured to follow all the medical devices standards.
Check the different features that this solution can provide to your company. And don’t hesitate to ask for a demo.
- Transforming Medical Compliance
- Expertise and Innovation
- Cloud-Based Security and Accessibility
- Comprehensive Regulatory Compliance
- Ready-to-Use Templates and Customization
- Global Collaboration and Integration
- Seamless Data Migration
- International Application and Scalability
- Licensing and Accessibility
- Customer-Centric Onboarding and Support
- Continuous Improvements Without Additional Costs
Core Processes of a Medical Device Quality Management System (QMS) - SmartEye eQMS is the All in one Solution for your QMS .
These processes form the foundation of a compliant, effective QMS for medical device companies:
1. Management
These processes ensure strategic alignment, resource allocation, and continuous improvement:
Processes:
2. Product Realization & Lifecycle Control
Focuses on turning ideas into compliant, safe, and effective medical devices:
Processes:
3. Compliance & Documentation
Ensures accurate, controlled documentation and electronic records (if applicable):
Processes:
4. Monitoring & Improvement
Processes focused on identifying, correcting, and preventing problems:
Processes:
5. Support & Compliance Enablement
These supporting processes ensure your QMS is usable, compliant, and scalable:
Processes: