Case Study: Fusion Innovations achieves a successful FDA-inspection-ready market launch with Greenlight Guru and Rook Quality Systems

How one MedTech company is benefitting from the complementary solutions of Greenlight Guru and Rook Quality Systems

Fusion Innovations, a small medical equipment manufacturer, needed comprehensive QMS implementation and quality management support to prepare for a successful market launch of its SternaFuse® sternal closure device. The company had already obtained FDA clearance, but it was struggling to make sufficient progress on its Greenlight Guru eQMS implementation and needed help finalizing its product development and quality management processes.

Greenlight Guru partner Rook Quality Systems (RookQS) stepped in to support the Greenlight Guru implementation, update DHF and QMS documentation, add risk management capabilities, and manage key quality activities such as audits, supplier onboarding, complaint handling, nonconformities, and CAPA. As a result, Fusion Innovations launched successfully with robust quality systems in place and later passed an FDA inspection in just two days with zero observations and zero recommendations, while continuing to use Greenlight Guru and work with RookQS for ongoing support.

Fusion Innovations