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Inside the First QMSR Inspections

Early enforcement data is in. Learn what investigators are prioritizing under the new 21 CFR Part 820 framework.

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FDA QMSR Transition: Your Guide to Compliance

Stay ahead in medical device compliance! Our latest blog post offers crucial insights for navigating the FDA's new Quality Management System Regulation (QMSR) transition, replacing the old QSR with an ISO 13485-based framework. Watch our helpful microlearning videos to guide you through ensuring your organization's seamless compliance.

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AI Governance for Life Sciences: ISO 42001 Training

Prepare your organization for the future of regulatory technology. This AI Management Systems (AIMS) training class will help you navigate AI risk and compliance with the new ISO/IEC 42001:2023 standard. The course offers life science professionals the framework to implement an effective AIMS, ensuring your Quality Management System (QMS) is integrated and ready for any audit.

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What Happened to QSIT? FDA's New Medical Device Inspection Compliance Program

The era of QSIT is officially over. Discover how the new FDA Compliance Program 7382.850 redefines medical device inspections with a rigorous focus on QMSR and risk-based decision-making.

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The QMSR is Here: Preparing for the FDA's Shift to ISO 13485

With the FDA's new Quality Management System Regulation (QMSR) now in effect, are you ready for the shift to ISO 13485:2016? Our blog provides essential insights and guidance for a smooth transition.

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DaySmart Training Classes.
One Day and Done — Only $995!

Need to get up-to-speed quickly but don’t have the time, need, or budget for an intensive multiday class? DaySmart classes are for you.

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Short Staffed?
Experiencing Project Overload?

Whether you’re a start-up that needs short-term RA/QA expertise, or an established company with more projects than staff to handle them, we can help. Learn how.

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Blog

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AI Is a Tool. So Why Does It Need a Management System?

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Apr 29, 2026

Did You Know? The QMSR Also Applies to Drug Device Combination Manufacturers

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inspection readiness blog
May 05, 2026

FDA QMSR Inspections: What Early Enforcement Results Reveal for Manufacturers

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GET TO KNOW US...

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