QMSR Effectiveness Bundle

Everything You Need to Succeed Under QMSR 

In one comprehensive package, the Quality System Effectiveness Bundle covers the essential quality and regulatory disciplines that every medical device company needs for QMSR including design controls, CAPA, risk management, complaints, and post-market compliance. 

Gain actionable insights into how these processes connect to strengthen compliance, drive smarter decisions, and build a more robust quality system. 

Created by seasoned industry experts with decades of FDA and medical device experience, these self-paced courses deliver practical, real-world implementation guidance you can apply immediately and use to stay inspection-ready.  

Build a Quality System That Works as an Integrated Whole 

With QMSR aligning more closely with ISO 13485:2016, medical device organizations need professionals who understand not only individual quality system requirements, but also how those requirements connect.  

This bundle will help you: 

• Understand FDA's QMSR requirements and ISO 13485 alignment 

• Apply risk-based thinking across the quality system  

• Strengthen compliance and inspection readiness 

• Improve decision-making and documentation practices 

• Build more effective quality system processes 

• Connect quality, regulatory, and operational activities across the product lifecycle 

• Support continuous improvement efforts throughout your organization 

Follow a Structured Path Through the Quality System 

1. QMSR Masterclass 

Gain a comprehensive understanding of FDA's updated Quality Management System Regulation and its convergence with ISO 13485:2016. Learn how global regulatory frameworks are becoming more aligned to support consistency and product quality.  

2. Management Review 

Learn the responsibilities of management under ISO 13485:2016 and develop practical approaches to planning, conducting, and documenting effective management reviews.  

3. Design Controls 

Build a working understanding of the design control process, including design phases, documentation expectations, and design change management.   

4. Risk Management 

Develop the skills needed to implement risk management as a continuous process across the entire product lifecycle using principles from ISO 14971.  

5. CAPA 

Learn how to establish and manage a closed-loop CAPA process that supports investigation, action planning, effectiveness verification, and sustained compliance.  

6. Complaints, Regulatory Reporting, and Recalls 

Understand the practical workflow for complaint handling, Medical Device Reporting (MDR), recalls, corrections, removals, and post-market decision making.  

Designed for those who need tips, tricks and a practical, connected understanding of the quality system requirements under QMSR. Ideal for professionals responsible for: 

• Quality systems 

• Regulatory compliance 

• Inspection readiness

• Product development oversight 

• Post-market quality activities 

• Quality and regulatory leadership 

Included with Your Enrollment 

✓ Six comprehensive courses 

✓ 12 months to complete all online, self-paced courses on your schedule and review materials as needed 

✓ Downloadable handouts 

✓ Practical implementation guidance 

✓ Expert-developed content 

✓ Real-world medical device examples