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Products
Aligned Elements

Aligned eQMS
Aligned Elements
Intelligent Design Control Management for medical device companies, driving correct, consistent, and compliant Technical File and DHF creation.
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Requirement Management
Capture and control requirements with a complete, chronological audit trail of all events.

Risk Management
ISO 14971 risk assessments. Identify, evaluate, mitigate, implement and verify all risks.

Test Management
Plan, execute, monitor and document hardware and software Verification and Validation activities.

Traceability Management
Let the traceability drive your design quality. Consistent and connected end-to-end tracing.

Document Management
Streamline document creation and approvals with electronic signatures and document routing.

Consistency and Completeness
Find and fix inconsistencies in seconds. Spot gaps before audits do.

Regulatory Compliance
Built for medical compliance to always be complete, correct and audit-ready.

Integrations
Connect Aligned Elements to your existing ecosystem of applications for a unified workflow.

Aligned eQMS
Unite medical device quality, regulatory and development teams and ensure compliant quality, maximizing efficiency with minimal administration.
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Document Control Management
Easy-to-use, secure and compliant document management.

Training Management
Ensure and document employee competence. Demonstrate compliance at any time.

Change Management
Change happens. Change drives you forward. You are prepared.

Quality Event Management
Feedback, Complaints, Nonconformities, CAPAs and Vigilance reporting.

Supplier Management
Select, approve, manage and monitor suppliers in a single location.

Audit Management
Confidently demonstrate compliance with organized, traceable audit planning.

Equipment Management
Track maintenance, calibrations, controls and repairs for all your important equipment.

Computer Software Validation Management
Assess, control and manage CSV data for full compliance.
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Discover real-world solutions to medtech challenges

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Support Documentation
User Manuals and Guides that give you control

Common Questions
Quickly find answers to frequently asked questions

Download Setups
Access and download installation executable for On-premise deployment

Release Notes
Discover what’s new and learn about recent features

System Requirements
Minimum and Recommended Server and Client Requirements

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Word Support FAQ

How can I import existing requirements/specifications from a Word Document?

See AE User Manual section 4.10 for details.

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