Fusion Innovations

Premise

In April 2022, Fusion Innovations reached out to Rook Quality Systems for assistance with completing their Greenlight Guru implementation. Fusion Innovation’s flagship product, SternaFuse®, is a modular, stainless steel sternal closure device that offers both time-saving flexibility for routine sternotomy closures and extensive capability for complex reconstructions, with individually packaged, sterilized implants for customized patient care.

In addition to supporting their Greenlight Guru eQMS implementation, Fusion Innovations sought out Rook Quality Systems (RookQS) for their expertise and transparent support to finalize their product development and quality management.

The company had previously struggled with insufficient progress while trying to solidify their Greenlight Guru implementation. Because of this, Fusion Innovations looked to RookQS for transparent and effective support to finalize their product development and quality management.

Scope of Work

Fusion Innovations had obtained FDA clearance for SternaFuse® before partnering with Rook Quality Systems. However, as they approached the validation phase, they recognized the need for Rook’s expertise in comprehensive quality management and risk assessment to achieve a successful market launch.

Engagement

RookQS provided comprehensive support to Fusion Innovations, addressing significant gaps in their Design History File (DHF) and Quality Management System (QMS) documents. Rook’s quality consultant leading this project worked diligently to update existing QMS documents, finalize the DHF, and integrated a new risk management module into their Greenlight Guru system. This consultant also led all quality activities, including supplier audits, complaint handling, nonconformities, Corrective and Preventive Actions (CAPA).

In preparation for Fusion Innovations’ market launch, RookQS offered ongoing quality support to ensure continuous compliance and improvement. The Rook team conducted internal audits and remote audits of critical suppliers in France. RookQS also managed supplier quality by assessing new suppliers and facilitating their onboarding, ensuring consistent and compliant manufacturing processes.

Outcome

Thanks to the diligent efforts of Rook Quality Systems (RQS), Fusion Innovations successfully launched their product to the market with robust quality management practices in place. In April 2024, RookQS supported Fusion Innovations onsite for their FDA inspection, which resulted in zero observations and zero recommendations. The FDA inspector was impressed by Fusion Innovations' eQMS and quality support, completing the inspection in just two days, significantly shorter than the typical 3-5 day duration.

Additionally, Fusion Innovations continues to utilize Greenlight Guru and maintains a strong partnership with RookQS for ongoing quality support. They are also exploring expansion into the Canadian regulatory market, with Rook poised to assist in this endeavor.

Rook Quality Systems' transparent and comprehensive approach to quality management and market preparation has enabled Fusion Innovations to achieve and maintain high standards of compliance and product quality, ensuring their success in the competitive medical device industry.