# Complaint Handling with Medical Device Guru, Brittney McIver

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-05-03
- Length: 38m
- Episode: 317
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-03-complaint-handling-with-medical-device-guru-brittney-mciver
- Listen: https://podcast.greenlight.guru/episode/complaint-handling-with-medical-device-guru-brittney-mciver

## Summary

Brittney McIver, a Medical Device Guru at Greenlight Guru and ISO 13485 Lead Auditor, explains the complexities of medical device complaint handling, from distinguishing valid complaints from general feedback to managing the sheer volume of customer feedback. She details the regulatory requirements under FDA 21 CFR Part 820.198 and ISO 13485, emphasizing the need for cross-functional investigation, traceability to Design History Files (DHF) and Device History Records (DHR), and proactive monitoring of social media and employee posts. McIver highlights the critical risk of customers bypassing manufacturers to report directly to the FDA and advises companies to implement robust Quality Management Systems (QMS) with clear implementation plans and dedicated complaint handling units.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-03-complaint-handling-with-medical-device-guru-brittney-mciver#t=0) Introduction: Brittney McIver and Greenlight Guru
- [2:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-03-complaint-handling-with-medical-device-guru-brittney-mciver#t=163) McIver's Background: Bioengineering, Extrusion, and Shadowing Surgeries
- [9:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-03-complaint-handling-with-medical-device-guru-brittney-mciver#t=570) The Reality of Complaint Handling: Volume and Cross-Functional Work
- [12:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-03-complaint-handling-with-medical-device-guru-brittney-mciver#t=731) Regulatory Requirements: FDA 21 CFR Part 820.198 and ISO 13485
- [17:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-03-complaint-handling-with-medical-device-guru-brittney-mciver#t=1059) Complaint Sources: Social Media, Employees, and Post-Market Surveillance
- [24:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-03-complaint-handling-with-medical-device-guru-brittney-mciver#t=1446) Investigation Techniques: Fishbone Diagrams, 5 Whys, and Traceability
- [31:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-03-complaint-handling-with-medical-device-guru-brittney-mciver#t=1869) Implementing QMS: Quality Plans, Manuals, and Onboarding Best Practices

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Clemson University (other)
- FDA (other)
- ISO 13485 (other)
- 21 CFR Part 820.198 (other)

## Related episodes from other shows

- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (Let's Combinate)
- [198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed) (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)
- [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)
- [125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-28-125-unpacking-the-quality-management-system-regulation-qmsr-final-rule-with-subh) (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/2023-05-03-complaint-handling-with-medical-device-guru-brittney-mciver. 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.