Meet Compliance Requirements

  • Organize compliance documentation
  • Allow secure sharing with appropriate people across the organization
  • Provide ability to scale globally
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For medical device companies, Arena’s Validation Maintenance Service offers complete impact analysis on all software updates, plus fully executed validation tests with results and an official validation certificate. Learn More.

Sector Challenges

From breakthroughs in personalized medicine, genomics, and medical devices, healthcare and life science companies are finding ways to advance human health more cost-effectively. Yet increased regulatory requirements challenge innovative companies to get to market quickly to take advantage of opportunities and reach their full potential.

Arena Benefits

Arena has been helping customers deal with their quality issues for over a decade.

To meet FDA and other regulations, life science and medical device companies must be able to manage information to show evidence of compliance while accelerating time to market. Arena makes audits easier and less time consuming with a cloud-based solution that consolidates all compliance information into one centralized system. The solution streamlines management of BOMs, the design history file (DHF), the device master record (DMR), and change orders.

As part of Arena PLM, Arena Quality provides highly regulated medical device companies with a superior enterprise-wide approach to quality. This holistic quality solution offers visibility, cross-functional team collaboration, and long-term tracking of quality resolutions.

Recognizing the problem of how to provide people access to manufacturing documents with historical records led us to consider a cloud solution and then we realized Arena was already doing this. Arena BOMControl was the solution we were going to build this company on.
— Carl Dupper, Director of Technical Operations, Yukon Medical
yukon medical

By integrating quality processes directly with the product record, Arena Quality enables medical device companies to better meet FDA regulations and product quality business processes, including; 21 CFR Part 11, 21 CFR Part 820 and CAPA (corrective action and preventive actions).

Business Results

By using Arena PLM to streamline their extended supply chain efficiencies, medical device companies are able to reduce costly errors and delays and accelerate their desired business results.

With Arena Quality, life science companies capture a more “complete quality picture,” allowing auditors to quickly and easily verify compliance. Medical device manufacturers benefit from continual process improvements, higher quality products, and cost reductions across the entire value chain.

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PLM Best Practices for Medical Device Manufacturers to Ensure Quality

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Life Sciences Customers