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Unlocking Improved Device Quality and Lessen Regulatory Burden with the Voluntary Improvement Program

European Medical Device Summit 2025
  • Boosting capacity and quality using an approach that meets your business needs
  • Leveraging US FDA opportunities for expedited PMA and Site Change submissions, and more benefits from FDA
  • See Final Guidance “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program”
  • Enhancing manufacturing efficiency for faster innovation
  • Using a maturity model to measure capabilities
  • Fostering a culture of continuous improvement for superior device quality
Mike Cook
Global Medical Device Sales Executive
The Voluntary Improvement Program