In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR).
We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up robust reporting processes and explains how manufacturers can avoid common pitfalls.
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Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
Key Timestamps
- [01:20] Introduction of Lisa Van Ryn and discussion on FDA’s Medical Device Reporting
- [05:45] Lisa’s transition from the restaurant industry to medical devices
- [10:30] What triggers a medical device report to the FDA?
- [15:25] Role-play on handling complaints and determining reportability
- [25:00] Detailed explanation of the decision tree for reporting
- [35:15] Differentiating between device malfunctions and serious injuries
- [40:10] Real-life examples and clarifying complex reporting scenarios
- [50:30] The repercussions of late reporting and the importance of timing
- [55:20] Wrapping up and resources for deeper understanding
Key Takeaways
- Understanding MDR: The importance of being thoroughly familiar with Medical Device Reporting guidelines to ensure proper reporting and compliance.
- Setting Up Processes: Tips on setting up an effective complaint handling system to manage and report incidents correctly.
- Common Pitfalls: Common issues manufacturers face and how to avoid them by implementing efficient and compliant processes.
Links:
Memorable quotes:
- “Every complaint needs to be evaluated to determine if it is reportable under 21 CFRR Part 803.” – Lisa Van Ryn
- “Having a beginner’s mindset but the heart of a teacher is essential in the medical device industry.” – Etienne Nichols
- “If you’re not considering the feedback as important, whether it’s reportable or not, you are missing valuable data.” – Lisa Van Ryn
Feedback:
Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
Sponsor:
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:
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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- Source: https://www.greenlight.guru/blog/medical-device-reporting-dos-and-donts