Hardware Podcasts

Tips for Running Better Management Reviews

Global Medical Device Podcast · 19 Jul 2021 · 24m · Episode 221

What this episode covers

Taylor Brown, a senior medical device guru at Greenlight Guru, joins host John Spear to discuss best practices for conducting effective management reviews under ISO 13485 and FDA 21 CFR Part 820. Brown shares a personal anecdote about a failed review where she focused on presentation rather than required inputs like complaints, leading to an audit finding. They emphasize that management reviews should be frequent (twice a year), data-driven, and focused on escalating issues and maintaining the Quality Management System (QMS) rather than just checking boxes.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru
Also
ISO 13485, FDA 21 CFR Part 820, Sarah Adams

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