PITTSBURGH, March 13 2025 – The Performance Review Institute (PRI) has joined the Voluntary Improvement Program (VIP)—a program developed with the United States Food & Drug Administration (FDA), the medical device industry, the Medical Device Innovation Consortium (MDIC), and ISACA and designed to help medical device companies accelerate product delivery while ensuring the highest standards of safety and quality. VIP empowers MedTech manufacturers by integrating a globally recognized continuous improvement model alongside regulatory opportunities. This unique combination enables companies to enhance efficiency, reduce costs, and expedite the development of innovative, life-saving medical technologies, ultimately benefiting patients worldwide. 

Through PRI’s partnership with ISACA, VIP utilizes expert-led appraisals to assess organizational capabilities and processes through team engagement, system demonstrations, and site tours. These insights help companies identify strengths and improvement areas, while ongoing appraisals and quarterly performance reviews develop an actionable plan to achieve recommendations. 

"We are excited to enter into this partnership with PRI," states Simona Rollinson, ISACA chief operating officer. "VIP offers a promising pathway to help improve the quality and safety of medical devices, and we are energized PRI’s commitment to drive progress toward our aligned goals." 

VIP aligns with the FDA Guidance, “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.” This guidance outlines how the program rewards device makers’ commitment to continuous improvement by reducing regulatory burdens. 

According to the FDA, qualified VIP participants may benefit from streamlined pre-market approval submissions, accelerated change notifications, optimized site change approvals, and risk-based inspection planning—supporting faster and safer product development. 

“This program reinforces PRI’s commitment to advancing quality, continuous improvement, and efficiency in the medical device industry,” stated Robert Lizewski, Vice President of Operations, MedAccred and Performance 360, PRI. “VIP not only reduces regulatory burdens for manufacturers but also accelerates the delivery of safer, more reliable medical devices to patients—aligning with our mission to drive excellence across the industry.”