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:
UNIFY
quality and product processes for better control and traceability
Identify
and resolve issues with closed-loop corrective and preventive actions (CAPA)
Ensure
compliance with FDA 21 CFR Part 820, Part 11, ISO 13485, EU 2017/745, and EU 2017/746
Adhere
to current good manufacturing practices (cGMPs)
COMPLY
with software validation regulations to reduce risks
CHECK OUT THE LIFE SCIENCES INDUSTRIES WE SERVE
COMPARE
QMS SOLUTIONS
See why Arena’s product-centric QMS is better.
LEADING INNOVATORS TRUST ARENA
SOMALOGIC RELIES ON ARENA
Arena’s SaaS solutions help Somalogic manage their digital product and quality records across dispersed teams.
QUALITY TALK
Sanjay Banerjee, COO at Potrero Medical, shares insights about quality and compliance strategies.
