Establish Your
Quality Culture

Simplify Product
Quality and Compliance

DELIVER MEDICAL DEVICES THAT EXCEED YOUR QUALITY GOALS

The burden to get compliant medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved—so, too, has the weight of the burdens these leaders face.

We help you overcome these challenges to eliminate product launch process delays, reduce compliance risks, and remove barriers that impede innovation.

Arena Quality Management System (QMS) software connects closed-loop quality management with product development processes in a single system. This product-centric approach simplifies compliance and reduces internal or external FDA, EU MDR, or ISO audit risks.

Arena QMS Ensures Compliance Through Product Launch

Our closed-loop quality management system provides quality teams with better transparency and traceability throughout the entire new product development and introduction process. This includes supporting compliant design controls. With Arena QMS, you can focus on what you do best. Arena Validate makes it easy to comply with software validation regulations under ISO 13485 and FDA Title 21 CFR 820.30.

Trust a Single Source of Truth

Arena QMS enables your teams to manage quality (DMRs, DHFs, SOPs, CAPAs) and training records in context to the entire product record (items, BOMs, AML/AVL). We streamline closed-loop quality management processes to reduce compliance and audit risks while enabling continuous improvement.

Demonstrate Training Competency

Track employee and partner training on new and revised standards, instructions, and procedures. Arena Training manages your employee and partner training plans and ensures everyone can demonstrate competency.

Develop Accurate Product Quality Tests

Synchronize inspection tests with the product revision. Arena integrates with quality control, CRM, and manufacturing execution systems. Quality assurance teams can define, revise, and review test specifications fast.

Design Safe, Innovative, and Compliant Products

Medical device manufacturers face many challenges—including 510(k) submissions and premarket approvals (PMA)—in their product launch journey before they can sell devices commercially. Arena QMS accelerates the development and delivery of safe products.

Arena QMS helps your quality teams: