Pittsbugh, PA—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 through team engagement, system demonstrations, and site tours. These insights help companies identify strengths and improvement areas, while ongoing appraisals and quarterly performance reviews ensure adherence to best practices.
"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 by the initiative's potential and by 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.”
Note to editors: For more information on the Voluntary Improvement Program, please visit https://www.p-r-i.org/performance360/voluntary-improvement-program, or for additional PRI services and programs, please visit Performance Review Institute (PRI) - We Protect What Matters (p-r-i.org)
The Performance Review Institute (PRI) is a not-for-profit trade association started in 1990. PRI is a global administrator of industry-managed critical process accreditation programs focused on improving process and quality with collaboration among stakeholders in industries where safety and quality are shared goals.
Ashley Keibler, Marketing Coordinator – Communications at PRI, 724-772-4002 or akeibler@p-r-i.org
About ISACA
ISACA® (www.isaca.org) represents the global workforce advancing trust in technology. For more than 55 years, ISACA has empowered its global community of 185,000+ members with the knowledge, credentials, training and network they need to thrive in fields like information security, governance, assurance, data privacy, risk management and emerging tech. With a presence in 195 countries and with nearly 230 chapters worldwide, ISACA offers resources tailored to every stage of members’ careers—helping them to thrive in a rapidly changing digital landscape, drive trusted innovation and ensure a more secure digital world. Through the ISACA Foundation, ISACA also champions IT education and career pathways for underrepresented and underresourced communities, fostering a diverse and inclusive technology workforce.
LinkedIn: www.linkedin.com/company/isaca
Facebook: www.facebook.com/ISACAGlobal
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Contact:
communications@isaca.org
Emily Ayala, +1.847.385.7223
Kristen Kessinger, +1.847.660.5512