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•Why Attend
•Workshop Topics
•Who Should Attend
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•Choose Your Bundle
Your Toolkit for Smarter, Safer Medical Devices
Are you navigating the complexity of risk management requirements while trying to accelerate product development? Are you looking for practical tools to ensure compliance without slowing down innovation? The Risk Management Toolbox Workshop at MD&M West addresses the exact challenges facing medical device professionals like you. We know you need hands-on skills and frameworks that work in the real world—not just theoretical knowledge. From early design to post-market surveillance, this workshop gives you the practical tools to identify, evaluate, and control risks while maintaining compliance with global standards like ISO 14971 and the FDA's evolving QMSR. Through case studies, exercises, and peer collaboration, you'll walk away ready to build safer, higher-performing devices and strengthen your quality management systems for long-term success.
Why Attend?
Master the Tools That Safeguard Devices and Patients
Actionable Insights
Learn step-by-step methods to identify and assess risk across design, manufacturing, and post-market phases—and apply them immediately to your projects.
Compliance Confidence
Understand how to align your risk management practices with FDA, ISO 14971, and EU MDR requirements to ensure continuous regulatory readiness.
Lifecycle Integration
See how leading MedTech companies integrate risk strategies into development and production processes to reduce errors, improve traceability, and enhance performance.
Hands-On Experience
Work through real-world examples and practical exercises that help you build, document, and evaluate effective risk management files and reports.
Workshop Topics
Foundations of Risk Management
Understand ISO 14971 principles, terminology, and the relationship between risk, quality, and product performance.
Risk Analysis and Evaluation Tools
Use tools like FMEA, FTA, and hazard analysis to identify potential failures and prioritize mitigation strategies.
Integrating Risk in Design & Development
Learn how to embed proactive risk thinking into your design inputs, verification/validation, and usability engineering.
Risk Control & Documentation
Gain best practices for documenting your risk files, linking design controls, and preparing for regulatory audits.
Post-Market Risk Management
See how complaint handling, CAPA, and trend reporting can feed into ongoing risk evaluation and improvement.
Who Should Attend
Key Decision Makers
- Quality Assurance & Regulatory Affairs Leaders
- Product Development Managers
- Risk & Compliance Officers
- Operations and Manufacturing Directors
Technical Professionals
- Design & Development Engineers
- Medical Device Engineers
- Quality Systems Specialists
- Process Validation Engineers
Who You’ll Meet
Join Our Community of Innovators
Industry Experts
Learn directly from instructors and speakers with decades of experience implementing risk frameworks across top MedTech companies.
Regulatory Specialists
Connect with auditors, consultants, and regulatory affairs experts who translate complex standards into practical, achievable processes.
Choose The Pass Bundle That Works Best For You
Enhance your expertise with a full day of hands-on cybersecurity training or bundle it with the three-day MedTech Conference for the complete experience. Deepen your understanding of how cybersecurity intersects with medical device design, regulation, and production. Together, these programs give you the tools and strategies to protect connected systems, ensure compliance, and strengthen product safety from concept to market.
All passes include full access to the MD&M West expo and free on-floor education.
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