How a Device Developer Transformed Quality Management With an Integrated QMS

How do companies evolve and grow in an ever-complex world of compliance, technology, deadlines, and customer demands? How can a company that is in acquisition mode benefit from a new approach to technology tools that allows for a plan to better all divisions involved? You’ll hear how in a compelling session at Masters Summit 2024 to be led by Edwin Chung, VP of professional services at SPK and Associates, and Jay DiToro, director of systems and technologies at Veranex. The session will include information on the transformative journey of Veranex’s quality management processes which will discuss the intricate challenges and robust solutions involved in enhancing Veranex's operational efficiency and compliance. This blog post provides a preview of what will be presented at the Masters Summit session.

Getting the Right Medical Device QMS in Place

Veranex, renowned for its extensive experience in medical product development, faced significant challenges with its medical device quality management systems (QMS), which were initially disparate and paper-driven across its various divisions that came from acquisitions. The implementation of a proven medical device QMS from solution provider MasterControl was a strategic move to harmonize these systems into a unified digital platform.

“We had very complicated paper-driven processes that were augmented by systems,” DiToro said, reflecting on the initial state of the medical device QMS. “A robust quality management system, eQMS, was crucial as we made acquisitions." This shift was not merely about adopting a new system but transforming the entire operational framework to enhance efficiency and regulatory compliance.

The transformation journey involved moving from a fragmented environment with homegrown systems and spreadsheets to a streamlined and efficient process facilitated by the new, purpose-built medical device QMS. The transition involved significant challenges, especially with the integration and harmonization of processes from multiple acquired companies.

"One of the things that all the companies had in common was QMS systems...but they all had very complicated paper-driven processes," DiToro explained. The move to a unified MasterControl platform and full QMS implementation enabled Veranex to centralize its quality management processes, ensuring more robust compliance with industry regulations and facilitating quicker, more reliable product development cycles.

Partnership for Medical Device QMS Innovation

Through the implementation process, DiToro relied on Chung and his team at SPK and Associates, a leading woman-owned engineering and IT services company that serves product and software development teams. DiToro entrusted Chung and his team to help drive many of these changes with the new medical device QMS and other process-based changes to lead them to a more streamlined and operationally capable business outcome.

The results of implementing the medical device QMS were profound. DiToro detailed the operational enhancements saying, "Because of that process, when COVID happened, we were able to quickly figure out how to deploy this [QMS solution] and accommodate the unexpected remote workers." The agility the cloud-based system provides proved invaluable during the sudden shift to remote work, enabling continuity and efficiency amidst unforeseen challenges. The benefits extended beyond mere compliance and operational efficiency. “The flexibility of being able to just create new vaults and life cycles so fast, easily, is a huge reason for our success the past few years," DiToro said.

Veranex's journey is a powerful testament to the potential of integrated quality management systems in driving business transformation. Through strategic implementation and expert guidance from SPK and Associates, Veranex not only enhanced its operational capabilities but also set a new standard in managing quality and medical device compliance efficiently across its global operations. For other companies navigating similar challenges, DiToro’s insights underscore the importance of adaptability and strategic integration of technology to achieve operational excellence and compliance in complex regulatory landscapes.

Join Chung and DiToro at Masters Summit to Learn More

As Veranex continues to redefine its operational strategies through QMS implementation and integration, their story stands as an inspiring example for organizations across industries facing similar challenges. Their session at Masters Summit, to be held October 14-18 at the Hyatt Regency in Salt Lake City, will not only spotlight Veranex's successful transformation but also the value of collaborative expertise that experienced consulting firms like SPK and Associates can provide. Whether you are looking to enhance your own QMS or simply aiming to understand the intricacies of quality management in a highly regulated environment, the presentation will offer invaluable insights and proven strategies. Join DiToro and Chung in Salt Lake City to hear firsthand how strategic technological integration can drive medical device compliance, efficiency, and business growth in today's competitive landscape.