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.

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

Insightful 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

Key Takeaways:

1. Understanding MDR: The importance of being thoroughly familiar with Medical Device Reporting guidelines to ensure proper reporting and compliance.
2. Setting Up Processes: Tips on setting up an effective complaint handling system to manage and report incidents correctly.
3. Common Pitfalls: Common issues manufacturers face and how to avoid them by implementing efficient and compliant processes.

References and Resources:

• Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records
• Lisa Van Ryn on LinkedIn
• Etienne Nichols on LinkedIn

Beginner’s Section: MedTech 101

• Medical Device Reporting (MDR): This refers to the regulatory process in which manufacturers are required to report certain types of incidents and malfunctions related to medical devices to the FDA.
• Serious Injury: A serious injury in the context of MDR is defined as an injury that is life-threatening, results in permanent impairment, or necessitates medical or surgical intervention to prevent permanent damage.
• Complaint Handling: The process by which manufacturers receive, review, and respond to customer complaints about the safety and quality of their medical devices.

Questions for the Audience:

• Poll: Do you believe current regulations on medical device reporting are sufficient for ensuring patient safety?

Feedback Request:

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Sponsors:

This episode is brought to you by Greenlight Guru, a leading platform that offers MedTech companies a comprehensive quality management software, designed to help navigate the complex landscape of medical device regulations.

Connect with Etienne Nichols:

Enhance your professional network by connecting with our host, Etienne Nichols, on LinkedIn!

For more resources and information, visit the Global Medical Device Podcast page.