From Concept to Medicine - A Comprehensive Drug Development Journey

184 - Episode 4 - Quality System Regulation (QSR): The Backbone of Medical Device Manufacturing (21 CFR Part 820) (S25E4)


Listen Later

In this deep dive, we explore the foundation of U.S. medical device quality regulation: the FDA’s Quality System Regulation, also known as 21 CFR Part 820. Framed as more than just paperwork, the QSR is revealed to be the operational heartbeat of device manufacturing, akin to a Michelin-starred kitchen where quality, safety, and consistency are designed into every step. From the first design sketch to the moment a device is packaged, stored, installed, and even serviced, the episode unpacks how manufacturers must embed robust controls across the entire lifecycle. It introduces essential documents like the DHF, DMR, and DHR, and connects them to practical examples in labeling, process validation, and cleaning procedures. The episode also demystifies change control, equipment qualification (DQ/IQ/OQ/PQ), supplier management, and post-market feedback systems.

But QSR is more than a technical checklist—it’s a culture. Listeners gain insight into how leadership, proactive risk management (ISO 14971), and a dynamic Quality Management System (QMS) underpin everything from training to audits. The episode also explores the global context, showing how ISO 13485 and EU MDR echo many of the same principles, helping harmonize standards across borders. The discussion on data integrity, ALCOA+ principles, and 21 CFR Part 11 brings modern digital systems into focus. Through compelling analogies and narrative structure, this episode elevates QSR from compliance burden to a living system of trust and safety that protects patients and elevates industry standards. It’s a must-listen for anyone working in—or entering—the medical device space.

...more
View all episodesView all episodes
Download on the App Store

From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

  • 4.2
  • 4.2
  • 4.2
  • 4.2
  • 4.2

4.2

5 ratings


More shows like From Concept to Medicine - A Comprehensive Drug Development Journey

View all
Freakonomics Radio by Freakonomics Radio + Stitcher

Freakonomics Radio

32,094 Listeners

Philosophize This! by Stephen West

Philosophize This!

15,119 Listeners

JAMA Clinical Reviews by JAMA Network

JAMA Clinical Reviews

502 Listeners

Odd Lots by Bloomberg

Odd Lots

1,905 Listeners

Up First from NPR by NPR

Up First from NPR

56,011 Listeners

Big Technology Podcast by Alex Kantrowitz

Big Technology Podcast

467 Listeners

The Economics of Everyday Things by Freakonomics Network & Zachary Crockett

The Economics of Everyday Things

1,611 Listeners