Setting the Stage for Success and Innovation

The burden placed on quality and operations leaders to introduce compliant and innovative medical devices is significant. Medical device manufacturers can reduce this burden and at the same time improve quality and product realization by following two principles.

Efforts and actions that focus on meeting FDA regulations and ISO standards should not be carried out or managed in isolation. To effectively compete, medical device manufacturers need to adopt holistic, connective approaches and tools for managing quality processes.

Regulated companies around the world are reaping the rewards of product-centric QMS to:

• Accelerate NPDI processes and get high-quality products to market fast
• Expedite readiness for regulations and requirements
• Go beyond the limitations of document-centric approaches to QMS
• Assure quality and product-centricity throughout NPD and NPI
• Drive closed-loop CAPA processes that tie to the product record
• Connect systems and eliminate disconnected teams and silos
• Maintain traceability and transparency at all times
• Reduce the pains and price of software validation

Helping Innovate Companies Change the World

At Arena, we help you design, produce, and deliver complex medical device products to market by connecting your product record, quality processes, and supply chain partners. This helps you create innovative, safe products to change the world.

For more on Arena and to discover a wealth of product-centric QMS resources and best practices, visit ArenaSolutions.com.

“Arena provides everything we need in one place—product lifecycle control, quality system control, collaboration, and more. We appreciate Arena’s focus on our product development and quality system needs.”

– Penny Dalton, Sr. Quality Systems Specialist, Nativis