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