Arena QMSArena, a PTC Business
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aligned elementsAligned AG
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Related Products
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About
Arena’s product-centric quality management system (QMS) software enables medical device manufacturers to deliver safe and compliant products to market fast. Arena QMS streamlines new product development and introduction (NPDI) by connecting quality and product processes. Arena QMS ensures regulatory compliance to quality standards and regulations including FDA 21 CFR Part 820, Part 11 and ISO 13485. Arena QMS enhances visibility and traceability by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans.
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About
Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity.
The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle.
Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Created for medical device manufacturers developing complex products.
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Audience
Medical Device Manufacturers looking for a design control management solution
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
€1300 per year
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationArena, a PTC Business
Founded: 2000
United States
www.arenasolutions.com/platform/qms/
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Company InformationAligned AG
Founded: 2007
Switzerland
www.aligned.ch/
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Categories |
Categories |
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Quality Management Features
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
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Application Lifecycle Management Features
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Requirements Management Features
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
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Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
Rimsys
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Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
Rimsys
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