What is Arena QMS?
Arena's quality management system (QMS) software is designed to help medical device manufacturers efficiently launch safe and compliant products in the marketplace. By integrating quality and product workflows, Arena QMS facilitates a smoother new product development and introduction (NPDI) process. It guarantees adherence to various quality standards and regulatory requirements, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS enhances visibility and traceability by overseeing quality processes in relation to bills of materials (BOMs), device master records (DMRs), standard operating procedures (SOPs), along with specifications, drawings, and training documentation. This holistic approach not only supports regulatory compliance but also fosters a culture of quality throughout the organization.
Integrations
Similar Software to Arena QMS
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Epsilon3 is the leading AI-powered procedure and resource management tool designed for teams building, testing, and operating advanced products and systems.
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Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk.
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Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box.
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Screenshots and Video
Company Facts
Company Name:
Arena, a PTC Business
Date Founded:
2000
Company Location:
United States
Company Website:
www.arenasolutions.com/platform/qms/
Product Details
Deployment
SaaS
Training Options
Documentation Hub
Online Training
Webinars
On-Site Training
Video Library
Support
Standard Support
Web-Based Support
Product Details
Target Company Sizes
11-50
51-200
201-500
501-1000
1001-5000
5001-10000
10001+
Target Organization Types
Mid Size Business
Small Business
Enterprise
Government
Startup
Supported Languages
Chinese (Simplified)
English
French
German
Spanish
Arena QMS Categories and Features
Quality Management Software
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management
ISO Standards Management
Risk Management
Supplier Quality Control
Training Management