Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program

Wednesday, April 23, 2025

10:55 AM - 11:40 AM East Coast USA Time

Location: Regency Ballroom – 3rd Floor

Discover how the FDA’s Voluntary Improvement Program (VIP) is elevating manufacturing practices and behaviors through which quality and safety of medical devices can be improved. This session will introduce participants to the program's benefits and objectives, followed by an overview of the appraisal process that drives measurable improvements. Hear directly from program participants as they share their experiences and outcomes. Join us to learn how VIP can support your commitment to quality and continuous improvement.

Moderator(s)

Aaron Dunbar

Vice President of Quality Systems & Post Market
Boston Scientific

Speaker(s)

Kim Kaplan

Senior Product Manager
ISACA

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Erin Keith (she/her/hers)

Materials Engineer, Compliance and Quality Program, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Virtual)
Roseanne Leaupepe

General Manager – Quality Systems
Fisher & Paykel Healthcare

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Keisha Thomas, MS, MHS, CQA, RAC

Associate Director for Compliance & Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

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