Engineering teams must overcome many obstacles to eliminate product development delays when designing innovative medical devices. Electrical, mechanical, and software design groups need to work together to ensure interoperability.
Arena Quality Management System (QMS) software brings the entire product record together and connects it to related quality records. This product-centric QMS approach ensures that all items, bills of materials (BOMs), approved manufacturers (AML), and related documents are controlled in one place.
Our QMS solution provides a more traceable, controlled, and connected system that allows you to view the design and related quality records in a single system anytime and anywhere.
As you move from concept through sustaining, we have you covered. Arena’s requirements management, issue management, and project management solutions come with Arena QMS, helping you accelerate design and development of safe devices.
Arena provides your product team instant access to product information, including the product design. This ensures your product can be built, tested, packaged, shipped, and supported as envisioned.
Arena reduces engineering change order (ECO) review cycle time with automated routings and approval processes. This enables engineering, quality, and related product teams to drive continuous improvement.
Arena QMS enables you to break down the barriers to product innovation during new product development (NPD) and new product introduction (NPI). Engineering teams can easily work together throughout product development to shorten approval cycles and speed time to market.
Arena’s product-centric QMS connects product and quality records from concept through commercialization. We help regulated life science companies:
interoperability of the total engineering design
with evolving FDA, EU MDR, ISO, and environmental regulations
engineering change and new product development
the design and drive continuous improvement
transparency and traceability to reduce audit risks
See why Arena’s product-centric QMS is better.