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The company must establish a program where they identify, analyze and control cybersecurity risks for both pre-market and post-market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to devise users.
A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant with the FDA requirements.
Why should you Attend:
Medical device cybersecurity has become very important to the FDA. They have recently issued two Guidance on the subject; the latest is in December of 2016. FDA expects a proactive extensive risk-based program to minimize risk to the user from cyber-attacks including active involvement with information-sharing groups.
Areas Covered in the Session:
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