Arena QMS

Arena QMS is a product-centric quality management system that is designed for medical device manufacturers to successfully deliver innovative and safe products while complying with FDA and ISO quality system regulations.

New product development and introduction (NPDI) can be streamlined by connecting quality and product processes.

Regulatory compliance can be ensured to quality standards and regulations including FDA 21 CFR Part 820, Part 11 and ISO 13485.

Visibility and traceability can be enhanced by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans.

Quality and product processes can be connected into a single, secure system by Arena's quality management system (QMS), helping you commercialize new products while ensuring compliance.

Visibility and traceability can be improved by managing quality processes throughout the entire product lifecycle.

Quality and regulatory compliance can be ensured by unifying quality processes.

Preparation for audits can be simplified.