Quality Management System

Product-Centric QMS Speeds Commercialization

The Challenge to Get Safe Products to Market

Global Compliance Regulations

For medical device and biotechnology companies with dispersed teams, it’s difficult to design and deliver high-quality products on time and ahead of the competition.

Addressing regulatory compliance challenges for ISO 13485, ISO 14971, Premarket Approvals (PMA), 510k, and FDA Title 21 CFR Part 820, and Part 11 is critical to market and commercialization success.

Without a single source of truth, your teams and suppliers struggle to stay on the same page. To meet stringent quality demands and drive continuous improvement, it’s critical to bring quality records and teams together so you can deliver safe and effective devices fast.

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

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

Drives Compliant Development Processes

  • Avoids confusion throughout new product development and introduction
  • Ensures employees and partners are trained with proven competence

Watch our 2-minute Arena Quality Management System video.

Why Product-Centric
QMS is Better

Managing disconnected quality and product systems creates confusion and delays commercialization efforts. WIth Arena’s product-centric quality management system, your internal teams and suppliers can stay on the same page throughout new product development (NPD) and new product introduction (NPI).

ARENA QMS BENEFITS

Ensures Compliance

Ensures Compliance

Unifies your quality management process to reduce FDA and ISO compliance risks and ensure the delivery of safe medical devices.

ADVANCES QUALITY

Enhances visibility and traceability by managing quality processes across all products in a single, connected QMS solution.

Advances Quality
Drives Innovation

Drives Innovation

Leverages closed-loop quality processes to drive continuous improvement and meet your market goals.

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

Improves product quality and drives continuous improvement with closed-loop processes.

Requirements Management

Drives connected requirements through product launch to align teams and eliminate errors.

Training
MANAGEMENT

Simplifies training management and ensures corporate, quality, and regulatory compliance.

Design
Controls

Establishes effective design controls to simplify FDA compliance, so you pass audits.

Design
Reviews

Improves design review processes to identify, evaluate, and resolve problems fast.

Issue
MANAGEMENT

Provides issue management for software, hardware, and electrical design and development.

SUPPLIER
MANAGEMENT

Helps identify, qualify, and procure compliant, competitively priced parts and assemblies.

Product
Development

Brings people, processes, and product information together to speed NPD and NPI.

Software
Validation

Simplifies and accelerates software validation to meet FDA regulations for each release.

Supply Chain Collaboration

Connects internal and external teams to drive fast, collaborative product development.

Product Record Control

Creates a single, controlled version of items, BOMs, AML, SOPs, and documentation.

DOWNLOAD THE QMS BRIEF

Read the full solution overview.

COMPARE
QMS SOLUTIONS

See why Arena’s product-centric QMS is better.

Single System with Lowest Total Cost of Ownership (TCO)

You need to get products designed and developed quickly to capture market share. Arena’s product-centric quality management system software speeds product launches while ensuring regulatory compliance with the lowest 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 CLOUD SOLUTIONS ACCELERATE RETURN ON INVESTMENT (ROI)

Dollar In Circle

CFOs and executives want to reduce long-term capital expenses and lengthy software implementations. Arena QMS provides a pay-as-you-go subscription model and best practices methodology to improve change efficiency, speed supply chain collaboration, and reduce costs.

Read our ebook to explore the benefits of cloud software systems aimed to help companies design, produce, and deliver high-quality products in this global environment.

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.

See why medical device companies rely on Arena Solutions to ensure compliance and get high-quality products to market fast.

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.

Leading Innovators Rely on Arena QMS

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SEE ARENA QMS
IN ACTION