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In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss the pivotal Voluntary Improvement Program (VIP). This conversation sheds light on how the program, stemming from FDA’s Case for Quality initiative, utilizes the Capability Maturity Model Integration (CMMI) to push medical device companies beyond compliance, towards excellence. Kaplan elucidates the history of VIP, its benefits, and how it aligns with the FDA’s vision for a more innovative and quality-focused MedTech industry.Key Timestamps:[00:00:30] Introduction of Kim Kaplan and the Voluntary Improvement Program[00:05:00] Explanation of CMMI and its adoption in the medical device industry[00:15:45] Distinctions between CMMI and other quality methodologies[00:25:30] In-depth discussion on the specifics and benefits of the Voluntary Improvement Program[00:40:00] How companies can implement change based on VIP insights[00:50:00] FDA’s