Case Study: IntraOp Medical Corporation achieves up-to-date quality visibility and regulatory compliance with Arena Solutions

Driving Quality Across Supply Chain to Highest Levels

IntraOp Medical Corporation, maker of the portable IntraOp Mobetron for intraoperative radiation therapy, develops complex electromechanical and software medical devices to accelerate cancer treatment. As an FDA- and international-regulated manufacturer, the company needed an integrated product and quality management solution to maintain compliance with regulations like FDA 21 CFR 820, ISO 13485 and MDD while eliminating time-consuming manual reporting.

IntraOp implemented the Arena platform for product and quality management and added Arena Analytics to visualize CAPA, nonconformances and supplier trends. The result is automated, up-to-date dashboards that replaced Excel-based manual crunching, improved decision-making and regulatory confidence, and enabled ongoing expansion into complaint handling and deeper CAPA and supplier analysis.

IntraOp

An Nguyen

Director of Regulatory Affairs & Quality Assurance