Hardware Podcasts

014B - "The Second P: Process" with Larry Mager

Let's Combinate · 5 Jan 2022 · 50m

What this episode covers

Larry Mager, Principal and Founder of Mgmt-Ctrl, explains the 'Process' component of quality management in medical device companies, distinguishing it from a basic Quality Management System (QMS). He outlines a five-step internal control framework: establishing a control environment, implementing risk mitigation, defining control activities, managing information flow, and conducting management review. Mager argues that this structured approach allows organizations to identify constraints and drive continuous improvement rather than just maintaining compliance. The discussion emphasizes that effective process management requires active leadership oversight and clear communication of objectives across all sites.

Most relevant to

established companies

Topics

Mentioned

Companies
Mgmt-Ctrl, FDA, ASQ
Also
21 CFR 820

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