Description
Aligned Elements is a comprehensive quality management solution specifically designed for medical device manufacturers. It simplifies the complex process of managing design history files (DHF) and technical files, ensuring compliance with stri...
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Use Cases
Key Features
- Task Management
- Status Tracking
- Change Management
- Collaboration Tools
- Document Management
- Traceability
Made For
Industries
- Medical Devices
- Pharmaceuticals
- Biotechnology
Customer Segments
- Small Businesses
- Mid-size Businesses
- Large Enterprises
Supported Platforms
- Web
- Mobile
Pros
- Streamlines DHF and Technical File Management
- Ensures Regulatory Compliance (FDA, ISO 13485, MDR)
- Improves Collaboration and Visibility Across Teams
Cons
- Potential learning curve for users unfamiliar with QMS systems
- Integration with legacy systems may require custom development
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