QMSR unpacked: FDA’s New Playbook for Quality System Readiness

QMSR Unpacked: FDA's New Playbook for Quality System Readiness

QMSR went live in February 2026, bringing with it a new Preamble and Investigations Operations Manual and a fresh set of expectations for medical device manufacturers.

Join ASQ Montreal for a practical look at how QMSR impacts design controls, risk management, CAPA, complaints, management review, and inspection readiness, all operating under the broader Culture of Quality umbrella.

Topics covered:
QMSR changes, FDA inspection trends, design controls, risk management, CAPA, complaints, management review, and readiness.

What you'll gain:
A clear understanding of what FDA expects, how key QMS processes connect, and what your organization can do now to prepare.

Why attend:
QMSR affects the entire organization. You'll see how each quality process works together to support compliance, readiness, and a stronger Culture of Quality.