Arena Product-Centric QMS
for Medical Device Companies
Improve Quality and Compliance
Ensure Compliance
Unify quality and product—all product definitions with
engineering changes and quality processes for a complete DMR— controlled access and traceability with no surprises.
Advance Quality
Manage quality processes across all products with all teams using a single product-centric QMS system—people and information connected to build continuous improvement.
Drive Innovation
Leverage your product-centric QMS to enable collaboration, closed-loop CAPA management, training management, business intelligence, and integrations to meet your quality, market, and cost goals.
What We Do
Arena’s product-centric QMS solution streamlines product realization processes with links to relational bills of materials (BOMs), engineering changes, and quality records to eliminate disconnected silos. Arena’s comprehensive quality management system improves management of Standard Operating Procedures (SOPs), Device Master Records (DMRs), and Design History Files (DHFs) to simplify compliance and reduce audit risks.
The Problem We Solve
Some life sciences companies can get by with document-centric QMS solutions. However, life science companies with mechanical, electrical, and software components require a product-centric QMS approach to connect the entire product record to training, CAPA, and quality records. Leveraging a single system of record to manage the product and related quality processes simplifies compliance and speeds time to market.
