About
Arena's product-centric quality management system (QMS) streamlines new product development and introduction (NPDI) by connecting quality and product processes. Arena ensures regulatory compliance to quality standards and regulations including FDA 21 CFR Part 820, Part 11 and ISO 13485. Arena QMS enhances visibility and traceability by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans.
This product is intended for
- Quality Assurance Manager
- Quality Engineer
- Quality Specialist
- Compliance Manager
- Operations Manager
- Director of Operations
- Design Engineer
- Engineering Manager
- Director of Quality Control
- Quality Assurance Quality Control Engineer
Media
Products media viewer
-
Arena QMS CAR
-
Arena QMS Training Management
Arena QMS automates employee training processes and ensures all teams can demonstrate competency in their roles.
-
Arena QMS Overview
Arena’s product-centric quality management system (QMS) software enables medical device manufacturers to deliver safe and compliant products to market fast. By connecting quality management processes to the product record, we help distributed teams improve visibility and traceability throughout the entire product lifecycle.