Introducing Learn leanRAQA, a carefully curated selection of online courses designed for busy regulatory professionals like you.
We’ve been in the medical device regulatory trenches, wrestled with 510(k)s, and emerged victorious from countless audits. Now, we’re spilling all our hard-earned secrets in a series of easily digestible, dare we say, enjoyable courses.
The course lessons are short and sweet (most can be completed in about 15 minutes) – perfect to squeeze in during your coffee break or between conference calls.
Explore our course catalog below, where your shortcut to regulatory zen awaits. Side effects may include increased confidence and a sudden urge to high-five your compliance officer.
Everything your team needs to succeed under QMSR—in one bundle.
The Learn leanRAQA Bundle brings together the core quality and regulatory disciplines every medical device company depends on—from QMSR and design controls to CAPA, risk management, complaints, and post-market compliance.
Rather than learning each topic in isolation, you’ll gain a practical understanding of how these processes work together to strengthen compliance, improve decision-making, and build a more effective quality system.
With self-paced, regulator-aligned training and real-world implementation guidance, your team can apply what they learn immediately and stay inspection-ready long after the courses are complete.
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Designed for regulatory, quality and compliance professionals, this masterclass provides a structured, expert-led approach to understanding and implementing the new QMSR requirements without unnecessary complexity.
Whether you are updating an existing quality management system or building one from the ground up, this course provides a clear and practical roadmap to FDA’s new QMSR.
Risk management isn’t just another regulatory requirement—it’s the framework that connects product safety, design decisions, quality activities, and post-market performance.
This course helps medical device professionals build a practical understanding of ISO 14971 and QMSR expectations, showing how to create a risk management process that supports better decisions, stronger compliance, and products that are easier to defend throughout their lifecycle.
Gain a practical understanding of FDA design control requirements under the Quality Management System Regulation (QMSR).
This course walks through the full design control process — from development planning and design inputs through reviews, verification, validation, transfer, and change control — using real-world medical device examples.
A practical, real-world course designed to help you bring clarity and consistency to your postmarket processes—so complaints, regulatory reporting, and recalls actually work together instead of against each other.
Learn how to make faster, more confident decisions, build defensible documentation, and stay inspection-ready without adding unnecessary complexity.
A practical, regulator-aligned course designed to help quality and regulatory teams build a CAPA system that actually works.
Learn how to initiate, investigate, document, and close CAPAs using risk-based logic that stands up to ISO 13485:2016 and FDA QMSR expectations—without overcomplicating the process or creating audit risk.
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The FDA’s new QMSR rule goes live in February 2026. For the first time, inspectors will review your full management review records.
This course shows you exactly how to run a review that meets the standard — and passes inspection with confidence.
