Hardware Podcasts

#324 Management Responsibility: The most important part of a QMS

Global Medical Device Podcast · 22 Jun 2023 · 42m · Episode 324

What this episode covers

Sara Adams, a Lead Auditor and Quality Engineer at Greenlight Guru, explains the critical role of management responsibility in a medical device Quality Management System (QMS). She details how top management must establish a meaningful quality policy, provide adequate resources, and conduct rigorous management reviews to ensure regulatory compliance and a culture of quality. Adams emphasizes that without active executive buy-in and cross-functional engagement, even well-documented systems fail to protect patients or satisfy auditors.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru
Products
Greenlight Guru Academy
Also
ISO 13485, FDA

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