“Don’t be comfortable saying, ‘Oh I follow the ISO (13485) to the letter’; it doesn’t matter. You have to comply with 21 CFR 820.”

In this Let’s Talk Risk! conversation, Neil Di Spirito, helps us understand the full legal context behind the Quality Management System Regulation (QMSR), the amended version of 21 CFR 820 that will go into effect in February 2026.

Although, the QMSR incorporates the International Standard ISO 13485:2016 by way of reference, there are points of differences and additional requirements for compliance to 21 CFR 820.

That is why it is important to carefully consider gaps from the current QSR against the full scope of QMSR, not just ISO 13485 requirements. It is not simply a technical matter, but also a legal matter that manufacturers should consider evaluating with help from a legal expert.

Neil advises manufacturers to consider operating two parallel processes right up to the exact date of QMSR enforcement, gain working experience to appropriately modify their approach for compliance. A good way to do this is through a Quality Plan.

Listen to this Let’s Talk Risk! conversation with Neil Di Spirito, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:02:45 Introduction

00:06:45 The legal basis of 21 CFR 820 modification to QMSR

00:11:20 QMSR lowers the compliance burden by harmonization with ISO 13485

00:15:59 Recommendations for manufacturers to prepare a transition to QMSR

00:18:50 Audience Q&A and general discussion

00:32:28 Closing comments and key takeaways

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Suggested links:

FDA: Frequently asked questions about QMSR

LTR webinar: Getting ready for QMSR

About Neil Di Spirito

Neil Di Spirito is the Principal at DiSpirito Law, PLLC, where he represents pharmaceutical, biologic and medical device companies in regulatory, commercial and FDA enforcement defense matters. He has 20+ years of industry experience in various roles including business management with P&L responsibility. He teaches introductory courses in pharmaceutical and medical device law to FDA new hires and industry legal professionals. He holds an MBA degree with specialization in Pharmaceutical Marketing and Management, and a Juris Doctor, Law degree.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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