Learn LeanRAQA Bundle
Complete Your Medical Device Quality & Regulatory Training in One Place
Whether you're preparing for QMSR, strengthening your quality management system, or developing your regulatory team, the Learn LeanRAQA Bundle provides practical, regulator-aligned training on the core quality system processes every medical device manufacturer depends on.
Developed by industry experts with decades of FDA and medical device experience, these self-paced courses translate complex regulations into practical workflows your team can apply immediately.
Included Courses
QMSR Masterclass
Get a comprehensive understanding of the FDA's Quality Management System Regulation (QMSR) and its alignment with ISO 13485:2016. Learn what changed, what it means for your organization, and how to prepare your quality system for successful implementation.Ā
Management Review
Learn how to build an effective management review process that drives continual improvement instead of becoming a compliance exercise. This course explains regulatory expectations, required inputs and outputs, and how management review supports the overall quality management system.
CAPA
Build a Corrective and Preventive Action system that regulators trust and teams can execute consistently. Learn how to conduct investigations, identify root causes, implement effective actions, and verify long-term effectiveness.
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Complaints, Regulatory Reporting, and Recalls
Understand the complete post-market process from complaint intake through Medical Device Reporting (MDR), corrections, removals, and recalls. Learn how to make defensible decisions while maintaining inspection-ready documentation.
Design Controls
Master the medical device design process from concept through commercialization. Learn how to implement design controls, develop traceability, perform verification and validation, manage design reviews, and control design changes under QMSR.
Risk Management
Apply ISO 14971 risk management principles across the entire product lifecycle. Learn how to identify hazards, evaluate risk, implement effective controls, and maintain a living risk management process using post-market data and continual improvement.
What's Included
Six comprehensive online courses
More than 30 self-paced lessons covering the most critical quality and regulatory processes for medical device manufacturers.
Practical implementation guidance
Move beyond regulatory theory with real-world examples, workflows, and best practices you can immediately apply to your quality system.
QMSR and ISO 13485 aligned
Training designed to help organizations understand and implement today's FDA quality system expectations.
Downloadable resources
Reference materials and practical tools to support procedure updates, internal training, and audit preparation.
Quizzes and certificates
Reinforce your learning with knowledge checks and earn a certificate of completion for each course.
One year of access
Learn at your own pace and revisit the courses anytime while implementing improvements or preparing for inspections.
Who This Bundle Is For
The LearnĀ LeanRAQA Bundle is designed for:
- Quality Assurance professionals
- Regulatory Affairs specialists
- Design and development engineers
- Manufacturing and operations teams
- Quality managers and regulatory leaders
- Organizations implementing or transitioning to QMSR
- Medical device companies training new employees or developing existing teams
Whether you're building a quality system from the ground up or strengthening an established program, this bundle provides practical training that supports long-term compliance and operational excellence.
Invest in the most important resource - Yourself.
Build the knowledge and confidence needed to navigate today's medical device quality landscape with the complete LearnĀ LeanRAQA Bundle.
Enroll today and receive immediate access to every course.
Enroll Now