Quality Management System

Product-Centric QMS Speeds Commercialization

SEE WHY ARENA QUALITY MANAGEMENT SYSTEM IS TOP RATED

Arena’s product-centric quality management system (QMS) connects quality and product designs into a single, secure system. This helps you introduce new products to market while ensuring regulatory compliance.

Arena’s QMS solution is the clear choice for medical device manufacturers.

Graphic-G2 Spring 2025 Leader “Arena, great to use fortraining and QMS.”

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The Challenge to Get Safe Products to Market

For highly regulated companies with dispersed teams, it’s difficult to design and deliver high-quality products on time.

You must be able to comply with ISO standards, FDA regulations, and more to drive commercialization success.

Without a single source of truth, it’s difficult to keep everyone on the same page. Watch our short two-minute Arena QMS video to learn how you can meet these demands and drive continuous improvement.

HOW WE HELP

Arena Quality Management System (QMS) software connects quality records directly to the product design in a single system. We help you document and track closed-loop quality processes for device master records (DMRs), design history files (DHFs), training records, and corrective and preventive actions (CAPAs) in context to the entire product record and bill of materials (BOM).

Produces Safe,
HIgh-Quality
Products

Simplifies compliance, improves design control, and reduces your audit risks
Fosters continuous improvement with traceable quality processes
Enhances visibility and traceability by managing quality processes throughout the entire product lifecycle

Creates a
Single System
of Truth

Leverages a single quality management system connected to the product design
Manages critical documents for training, SOPs, DMRs, DHFs, and CAPAs
Leverages closed-loop quality processes to speed resolution of issues

Drives Compliant Development Processes

Avoids confusion throughout new product development and introduction
Ensures employees and partners are trained with proven competence
Unifies your quality management process to reduce FDA and ISO compliance risks

Why Product-Centric QMS is Better

Managing disconnected quality and product systems creates confusion and delays commercialization efforts. With Arena’s product-centric QMS software, everyone can stay on the same page throughout the new product development and new product introduction process.

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WHY ARENA’S CLOUD PLATFORM IS BETTER

You need to get products designed and developed quickly to capture market share. Arena’s cloud-based quality management system software speeds product launches while ensuring regulatory compliance with the lowest total cost of ownership (TCO).

Scalable

Arena’s multi-tenant platform is designed to maximize performance, reduce cost, and automate recovery while allowing us to deliver regular enhancements to ensure maximum usability and scalability.

Collaborative

We provide a modern cloud experience, designed to simplify collaboration between you and your partners. You and your partners have controlled, role-based access anytime and anywhere.

Affordable

Our configurable solutions and proven, best-practice implementation methodology eliminate risky science projects and costly coding to provide the lowest TCO.

HOW ARENA QMS MEETS YOUR TEAM GOALS

Arena QMS brings quality and related product development teams together to speed commercialization efforts, simplify regulatory compliance, and drive continuous improvement.

Arena QMS helps everyone work together and provides significant value for these teams:

QUALITY

QMS FOR QUALITY

OPERATIONS

QMS FOR OPERATIONS

ENGINEERING

QMS FOR ENGINEERING

ENSURE COMPLIANCE AND EXCEED QUALITY GOALS

Arena QMS streamlines product realization processes by connecting quality and product records. Our product-centric quality management system improves control of SOPs, DMRs, DHFs, BOMs, documents, training records, and more to simplify compliance.

QUALITY
MANAGEMENT

DESIGN CONTROLS
& REVIEW

SUPPLIER collaboration

training
MANAGEMENT

requirements
MANAGEMENT

ISSUE
MANAGEMENT

PRODUCT
DEVELOPMENT

SOFTWARE
VALIDATION

PRODUCT RECORD CONTROL

Learn more about Arena’s product-centric QMS solution.

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Hidden Costs of Quality Mistakes: How Much Can You Save?

Bringing a product from concept to commercialization is hard. It’s often difficult to see the impact and costs of a quality mistake. A single mistake can be a learning experience or delay your next product launch and cost millions.

We’ve leveraged real-world cost impact information, validated by our customers, to help you quickly determine how much you can save by avoiding common quality process mistakes.

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INDUSTRIES WE SERVE

If you design complex medical devices, you need to manage the full development process while meeting FDA and ISO regulatory standards. Learn how Arena’s enterprise QMS platform addresses medical device and biotechnology industry challenges.

INDUSTRIES