Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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 device users. A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant to the FDA requirements.
Why you should Attend: Medical device cybersecurity has become very important to the FDA. They have recently issued two Guidance's on the subject; the latest 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: