Our four class exercises cover:ġ) risk analysis for medical device mobile appsĢ) risk assessments and risk controls for software hazardsĤ) cybersecurity risk assessments and risk controls 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. 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. Lisa Simone, Software Review Team Lead and Policy Advisor, Office of Blood Research and Review, CBER, FDA Fubin Wu, Workshop Leader and Co-Founder of GessNet - software and consulting company specializing in medical device risk management.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. 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.
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