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Quality & Regulatory Systems

A commitment to quality leadership, worldwide, permeates Nypro Healthcare's quality systems. ASQ certified quality engineers transform quality from a cornerstone philosophy to a way of life....a way of life that touches all planning, development and manufacturing activities.

At the core is the Nypro Worldwide Quality System (NWQS), a web-based electronic application that integrates document generation, approval, and CAPA across all Nypro locations. Consistent execution insures stability of supply and minimizes risk on a global basis.

Our operations are registered to ISO 13485 in full compliance with cGMP, the QSR and applicable CFR's. We meet these standards with mature systems that are rigorously audited and calibrated with industry expectations on a continual basis. Our Lean Six Sigma philosophy is woven into the fabric of our operations.

Our quality team has a rich understanding of global regulatory and industry trends. Our goal is to work with your development and quality/regulatory groups to apply processes and pre-launch rigor that will reduce approval time, time to market, and post-launch issues.

Questions? Ready to Talk?

From Jabil's Blog

Connected Health in the Changing Medical Device Ecosystem

If you traveled back in time several centuries, you would find little change in the treatment of sick and diseased individuals in society until the mid-19th century when hospitals were developed, beginning the organization of heal ... Read More

[eBook] Connected Health - Transforming the Healthcare Industry

The first release in our Summer Reading Series Around the world, healthcare systems struggle with unprecedented unsustainable rises in costs and demand for expanding access to care. And healthcare innovators are re-evaluating how ... Read More