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Demystifying QMSR: Are you Ready?

Thu, Jan 15

|

Zoom

The FDA’s Quality Management System Regulation (QMSR) takes effect on February 2, 2026—and the time to act is now.

Demystifying QMSR: Are you Ready?
Demystifying QMSR: Are you Ready?

Time & Location

Jan 15, 2026, 11:00 AM – 12:00 PM

Zoom

About the event

The FDA’s Quality Management System Regulation (QMSR) takes effect on February 2, 2026—and the time to act is now.


Join us for a free, focused 1-hour session that breaks down what’s changing, what compliance really requires, and how to start building (or refining) your QMSR transition plan.


Key Discussion Topics:


• Key shifts from 21 CFR Part 820 to QMSR


• What the regulation and preamble signal about FDA audit expectations


• How to apply a risk-based, ISO 13485-aligned approach


• Practical transition strategies and tools


• Live Q&A to address your top questions



📅 Date: January 15, 2026


⏰ Time: 11:00 AM – 12:00 PM PST


💵 Cost: FREE



This session will provide clarity and next steps—wherever your organization is in the QMSR journey.


📢 Presented by: Jennifer Mascioli-Tudor, MBA, CQA, Founder of JMT Compliance Consulting — supporting MedTech teams with QMSR readiness, audit prep, and quality system transformation.


🔄 Like, comment, or share to help others in the MedTech community prepare for this important regulatory shift.

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