Dr. Yuan Li, Director of Medical Business at DQS and a former medical device auditor with deep expertise across orthopaedic manufacturing and regulatory systems.

In this episode, we discuss the sweeping regulatory transition coming to the U.S. with the introduction of the Quality Management System Regulation (QMSR), which formally aligns 21 CFR Part 820 with ISO 13485. Yuan unpacks what this shift means for U.S.-based manufacturers, why FDA is phasing out the QSR audit model and why contract manufacturers and software-based device firms are particularly vulnerable if they delay planning.

We also explore the growing use of AI in QMS platforms, the pitfalls of template-driven compliance, and why “regulatory fatigue” is no excuse when patients’ lives are at stake. From post-market surveillance strategies to paperless QMS migrations and the validation grey zone, Yuan offers pragmatic, deeply informed advice for those navigating FDA audits, ISO certification and international expansion

Timestamps

[00:02:36] Why QMSR is a Big Deal for U.S. Manufacturers

[00:04:09] Key Differences Between 21 CFR 820 and ISO 13485

[00:05:09] Why Companies Wait Too Long to Comply

[00:07:19] Impact on Contract Manufacturers and Supply Chains

[00:08:36] Do You Really Need ISO 13485 Certification?

[00:10:18] AI-Generated QMS Systems: Useful or Risky?

[00:11:52] Most Memorable Audit Story: Iterative Design Gone Wrong

[00:14:46] How to Spot Proactive vs Reactive Post-Market Surveillance

[00:17:03] Why Software Companies Struggle with The Regulatory Mindset

[00:20:57] What Validation Really Means Under ISO 13485

Connect with Yuan - ⁠https://www.linkedin.com/in/yuan-li-phd-3bb14013/

Learn more about DQS - ⁠https://www.dqsglobal.com/en/

Get in touch with Karandeep Badwal - ⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠

Follow Karandeep on YouTube - ⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠

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