# Understanding and Handling Different Types of Feedback

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-01-14
- Length: 34m
- Episode: 175
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback
- Listen: https://podcast.greenlight.guru/episode/understanding-and-handling-different-types-of-feedback

## Summary

Isabella Schmitt, Director of Regulatory Affairs at Proxima Clinical Research, explains the regulatory distinctions between product feedback, complaints, and adverse events for medical device companies. She details the criteria for classifying complaints under 21 CFR 820, the strict timelines for filing Medical Device Reports (MDRs) with the FDA for deaths or serious injuries, and the importance of proactive monitoring via databases like MAUDE. Schmitt emphasizes that all staff must be trained to capture feedback to ensure qualified personnel can determine if an event requires investigation or root cause analysis.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback#t=0) Introduction: Isabella Schmitt and Proxima Clinical Research
- [2:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback#t=121) Defining Complaints vs. Feedback under 21 CFR 820
- [6:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback#t=410) The Value of Capturing Non-Complaint Feedback
- [12:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback#t=742) Adverse Events, MDRs, and FDA Reporting Timelines
- [17:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback#t=1041) Proactive Monitoring: MAUDE, Social Media, and Trade Shows
- [23:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback#t=1411) Investigation Processes and Root Cause Analysis
- [29:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback#t=1790) Gathering Information: The 5 Ws and Reporter Follow-up

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

early-stage companies

## Mentioned

- Proxima Clinical Research (company)
- Green Light Guru (company)
- FDA (other)
- MAUDE (other)
- 21 CFR 820 (other)
- ISO 13485 (other)

## Related episodes from other shows

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- [117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards) (Let's Combinate)
- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)

## 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/2021-01-14-understanding-and-handling-different-types-of-feedback. 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.