Hardware Podcasts

100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager

Let's Combinate · 30 Aug 2023 · 30m

What this episode covers

Larry Mager, Principal at Mgmt-Ctrl and founder of PQMCoach.com, discusses his evolution from a Fortune 500 quality engineer to a startup operator who built a Quality Management System (QMS) from scratch for a cardiovascular device. He explains the shift from 'Big Q' compliance to 'Little Q' operational excellence, detailing how he navigated an FDA consent decree at a large manufacturer and later moved into consulting to address communication barriers in quality management. Mager advocates for Predictive Quality Management (PQM) and the Plan-Do-Check-Act (PDCA) cycle as universal tools for improving business performance across pharma, medical devices, and CROs.

Most relevant to

companies scaling up and established companies

Topics

Mentioned

Companies
Mgmt-Ctrl
Products
Da Vinci robot
Also
PQMCoach.com, FDA, EUMDR

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