Manage your Quality Management System transition
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Countdown to February 2, 2026
The clock is ticking for the required implementation date of FDA’s new QMSR regulations, which integrate the international QMS standard ISO 14385 into requirements for device manufacturers’ quality management systems.
Are you ready?
If not, we are here to help – starting with an invaluable source of transition information.
Navigating the QMSR provides manufacturers, auditors, and quality professionals with the tools and insight needed to successfully transition from the FDA’s long-standing Quality System Regulation (QSR) to the newly harmonized Quality Management System Regulation (QMSR) – a change that will redefine compliance for years to come.
Drawing on decades of regulatory and quality leadership, Bruce Waldon translates complex regulatory text into practical, actionable guidance aligned with ISO 13485:2016.
How it Will Facilitate Your Transition
Whether you are developing a gap analysis, updating documentation, or preparing for your first FDA inspection under the new rule, this book is your concise, authoritative reference.
Because “Compliance is no longer about avoiding findings — it’s about building systems that elevate quality and trust.”
Available in paperback and eBook formats on Amazon. Click on the image or this link to see the book on the Amazon website.
Three Core Benefits
Clarity Where It Counts
Understand every clause change and its real-world impact. Navigating the Transition from the QSR to the QMSR distills FDA and ISO expectations into clear explanations, examples, and mapping tables.
Practical Application Tools
Implement the new requirements with ready-to-use templates, checklists, and step-by-step transition strategies — drawn from proven industry practice.
Confidence in Compliance
Move beyond uncertainty. Learn how to document, train, and audit your system with assurance that your organization is fully aligned with the QMSR’s 2026 requirements.