# #358: FDAs Voluntary Improvement Program

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-03-21
- Length: 28m
- Episode: 358
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-21-358-fdas-voluntary-improvement-program
- Listen: https://podcast.greenlight.guru/episode/358-fdas-voluntary-improvement-program

## Summary

Kim Kaplan from ISACA explains the FDA’s Voluntary Improvement Program (VIP), which uses the CMMI framework to help medical device companies move beyond basic compliance toward operational excellence. She details how the program identifies gaps in project management and data measurement, offering participants regulatory benefits like waived inspections and faster change notice approvals. Kaplan emphasizes that VIP is designed for organizations that are already compliant and seeking continuous improvement, rather than startups needing initial FDA registration.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-21-358-fdas-voluntary-improvement-program#t=0) Introduction and VIP History
- [4:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-21-358-fdas-voluntary-improvement-program#t=248) CMMI Framework and Methodology
- [7:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-21-358-fdas-voluntary-improvement-program#t=469) Medical Device Industry Strengths and Gaps
- [9:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-21-358-fdas-voluntary-improvement-program#t=579) VIP Appraisal Process and Confidentiality
- [14:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-21-358-fdas-voluntary-improvement-program#t=884) Regulatory Benefits and Cost Savings
- [23:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-21-358-fdas-voluntary-improvement-program#t=1381) Implementation and Change Management

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

established companies

## Mentioned

- Green Light Guru (company)
- CMMI (tool)
- MDIC (company)
- Deloitte (company)
- FDA (company)

## Related episodes from other shows

- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)
- [253 - FDA Is Making Big Changes to Its Inspection Approach](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach) (Let's Combinate)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)
- [024 - "Operating Under Constraints "with Naveen Agarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal) (Let's Combinate)
- [155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-21-358-fdas-voluntary-improvement-program. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.