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 instructors will be:
- Fubin Wu, Workshop Leader and Co-Founder of GessNet — software and consulting company specializing in medical device risk management
- Dr. Lisa Simone, Software Review Team Lead and Policy Advisor, Office of Blood Research and Review, CBER, FDA
- Dr. Seth D. Carmody, Staff Fellow, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA (invited)
In two days of intensive sessions, you will be brought up to date on the FDA’s latest guidances 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 four class exercises, always a popular and valuable way to learn. Our four class exercises cover:
1) risk analysis for medical device mobile apps
2) risk assessments and risk controls for software hazards
3) cybersecurity risk analysis
4) cybersecurity risk assessments and risk controls
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, Dr. Simone and Dr. Carmody will share techniques and best practices on how to:
- identify software related risks
- identify, assess and manage safety risks
- perform cybersecurity risk analysis (assets, threats, vulnerabilitites, security risk assessments and controls)
- document medical device safety and cybersecurity risk analysis for stakeholders (internal reviewers, FDA reviewers, hospital, etc.)
- build assurance cases demonstrating device safety and cybersecurity
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.