This workshop — chaired by internationally renowned expert Fubin Wu — has been specifically designed to provide you with industry best practices to achieve compliance and effectively assure medical device software safety.
In fact, it's a once-in-a-lifetime opportunity to learn how the FDA expects you to manage the risks of your medical devices that contain software.
Your instructor will be:
- Fubin Wu, Workshop Leader and Co-Founder of GessNet — software and consulting company specializing in medical device risk management
In two days of intensive sessions, you will be brought up to date on the FDA’s latest research on medical device software best practices, software risk management related standards and guidances and key success factors for effective software risk management.
Plus, in a special bonus, you’ll find out more about assurance levels — and what it will take to convince regulators — in one of our seven invaluable case studies, always a popular and valuable way to learn. Our seven case studies cover:
1) Best practices and a template for developing a risk traceability matrix
2) Best practices and a template for developing a cybersecurity risk traceability matrix
3) how to convincingly document information in a storytelling fashion for a medical device safety assurance case
4) How to convincingly document information for a medical device cybersecurity assurance case
5) How to apply techniques on identifying and connecting hazards, hazardous situations/causes using device examples
6) How to identify and connect assets, threats and vulnerabilities using device examples
7) How to identify and apply risk controls — and establish traceability of its implementation — using device examples
Spread throughout the course will be lessons in applying these key software risk management related standards and guidances to your software development processes:
- ISO 14971:2007 and EN ISO 14971:2012, IEC 62304 Medical Device Life Cycle Process, IEC TR 80002-1 Application of ISO 14971 for Software
- FDA Guidance on Mobile Medical Applications, Cybersecurity in Medical Devices, Infusion Pump Total Product Life Cycle
During each teaching session, Mr. Wu will share techniques and best practices on how to:
- Identify software related risks
- Identify software risk control and mitigation measures
- Assess and evaluate risk contributed/caused by software (premarket and post-market field issues)
- Assure the completeness and adequacy of risk management
- Communicate risk management information throughout the life of the product
- Key success factors for effective software risk management
Special Take-Home Resource Kit: You'll take home a jam-packed resource kit with more than 20 templates, checklists, case studies, guidances and supporting information. These are the tools that will help you effectively carry out the lessons you've learned over the two-day conference.
In closing, here's what you can expect to walk away with at the end of two intense days at Software and Cybersecurity Risk Management for Medical Devices:
- Understanding of how medical device manufacturers can overcome both technical and regulatory compliance challenges
- The resources and tools to help you succeed
- The medical device industry’s best practices
- The FDA’s latest updates on medical device software best practices
Why wait? Sign up NOW. In fact, bring your entire team (at a discount!) to hear this outstanding faculty of experts who will present, clarify and discuss all the critical issues surrounding this most complicated of issues confronting medical device manufacturers today.