Speaking the Language of IVD

April 18, 2024


In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal consultant and IVD expert at Qserve Group.

With over 25 years of experience, Christie shares her extensive knowledge, discussing the nuances of IVDs, regulatory landscapes, and practical insights for professionals transitioning into or within the IVD sector.

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Key Timestamps

  • [00:00:45] - Christie Hughes's introduction and background in IVDs
  • [00:03:30] - Discussion on the regulatory challenges and trends in 2023
  • [00:15:22] - Differences between IVDs and other medical devices in terms of regulatory and operational frameworks
  • [00:25:50] - Impact of regulatory changes on labs and manufacturers
  • [00:40:10] - Detailed exploration of user needs and design controls in IVD development
  • [00:52:00] - Advice for medical device professionals entering the IVD space

Key Takeaways:

  1. Trends in MedTech: The regulatory environment for IVDs is rapidly evolving, with increased scrutiny and changes in compliance requirements globally.
  2. Practical Tips: For those entering the IVD field, familiarize yourself with FDA decision summaries and EUA documentation to understand current regulatory expectations.
  3. Future Predictions: Expect continued integration of IVDs with digital health technologies, raising both opportunities and regulatory complexities.

Practical Tips for Listeners:

  1. Understand the components of your QMS and ensure they align with regulatory requirements.
  2. Regularly review and update your QMS to adapt to new regulations and technologies.
  3. Consider electronic solutions for better traceability and compliance.


Memorable quote:

  • "Understanding the user—whether a lab technician or a layperson—is critical in IVD development to ensure safety and effectiveness." - Christie Hughes


Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.


This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed specifically for medical device companies. Streamline your processes and stay compliant with Greenlight Guru.

About the Global Medical Device Podcast:

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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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