Hardware Podcasts

Complaint Handling with Medical Device Guru, Brittney McIver

Global Medical Device Podcast · 3 May 2023 · 38m · Episode 317

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Also
Clemson University, FDA, ISO 13485, 21 CFR Part 820.198

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