Driving Innovation

Our Customers Are Industry Leaders

Medical Device

Helping You Design Safe, Innovative, and Compliant Products

Medical device manufacturers face many challenges to successfully deliver innovative and safe products while complying with FDA and ISO quality system regulations. Traditional document-centric quality management tools fail to manage the full product record, including complex bill of materials (BOMs), which results in disconnected quality and product development systems.

Arena’s product-centric quality management system (QMS) connects quality and product development processes together to help medical device manufacturers avoid:

  • Silos of product and quality records
  • Disconnected quality, engineering, operations, and supply chain teams
  • Issues creating necessary design controls to comply with quality system regulations
  • Problems creating and tracking product requirements through design output
  • Quality and product issues stemming from poor training processes
Arena QMS benefits include:
  • Unifying quality and product record management to enable complete control and traceability
  • Addressing quality issues earlier with product BOM visibility
  • Assuring continuous compliance with FDA 21 CFR Part 820, FDA 21 CFR Part 11, and ISO 13485
  • Adhering to current good manufacturing practices (cGMPs)
  • Decreasing audit risks and simplifying audit processes
  • Identifying, analyzing, and resolving quality issues quickly with closed-loop CAPA

Customer Success

Arena Provides Single Solution

"Arena can do it all: manage your bill of materials (BOMs), quality system, documents, device returns, nonconformance, and your entire CAPA."

– Kim Khoe, Director of Regulatory Affairs and Quality Assurance, Apical Instruments

See Apical Instuments Success Story

Medical Device Cusomters