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:
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:
During each teaching session, Mr. Wu and Dr. Simone will share techniques and best practices on how to:
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:
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.
Your Expert Speakers
Co-Founder of GessNet
Dr. Lisa Simone,
Software Review Team Lead and Policy Advisor, Office of Blood Research and Review, CBER, FDA
Who will benefit?
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.