Compliant Document Control

Support Engineering, Operations, and Compliance Goals

Be confident preparing for internal, FDA, or other audits.

  • Arena’s product-centric QMS solution maintains all related records in one controlled place.
  • Create, manage, and track compliant device master records (DMRs) and design history files (DHFs) with Arena.
  • Speed issue resolution with closed-loop CAPA processes connected to product, quality, and training records.

Is Product-Centric QMS Right for Your Company?

See Product-Centric QMS

Quality and product teams work seamlessly to speed product realization processes.

  • Arena enables the entire product team to collaborate simply and effectively throughout new product development and introduction (NPDI).
  • Engineering, operations, quality, customer support, and partners share input during change and quality reviews to improve quality and speed product delivery.
  • Benefit from business-ready CRM integrations to connect customer feedback and speed resolution.
Kinsa Testimonial

“We are an FDA-cleared company. Product defects must be traced from customer complaint to suppliers through resolution.”

Jason Howard, Director of Customer Happiness, KinsaKinsa

Use each team member’s knowledge to improve your products.

  • With Arena, your internal teams and partners can securely collaborate throughout the new product introduction process.
  • Gain better insights from the team’s collective experience to optimize product quality.
Pulse Testimonial

“We wanted to have a closed-loop system with everyone collaboratively working on the same current product definition, through the same processes, to the same goals.”

Guneet Bhogal, Quality Assurance Specialist, Pulse BiosciencesPulse

At Arena, we help both leading and emerging medical device companies bring innovative products to market and comply with FDA and other regulations.