# #365: Medical Device Reporting: The Do's and Don'ts

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-05-07
- Length: 40m
- Episode: 365
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts
- Listen: https://podcast.greenlight.guru/episode/365-medical-device-reporting

## Summary

Lisa Van Ryn, a medical device guru at Greenlight Guru, explains the FDA’s Medical Device Reporting (MDR) requirements, detailing how manufacturers must evaluate complaints to determine reportability under 21 CFR Part 803. She outlines a decision tree for identifying serious injuries and device malfunctions, emphasizing that the reporting clock starts when any company employee becomes aware of an event, not just quality staff. Van Ryn highlights the distinction between 5-day and 30-day reports based on the need for remedial action to prevent public health risks, and warns against the pitfalls of ignoring customer feedback for trend analysis.

## Chapters

- [0:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts#t=50) Introduction: Lisa Van Ryn and Greenlight Guru
- [4:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts#t=294) Defining Complaints and the Decision Tree
- [12:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts#t=737) Setting Up Complaint Management Systems
- [16:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts#t=977) Determining Reportability: Death, Injury, and Malfunction
- [27:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts#t=1672) 5-Day vs 30-Day Reporting and Remedial Action
- [30:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts#t=1850) The Reporting Clock and Follow-Up Requirements
- [37:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts#t=2234) Preparing for FDA Submission and e-Submitter

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (company)
- e-Submitter (tool)

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## 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/2024-05-07-365-medical-device-reporting-the-dos-and-donts. 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.