Description : How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures can lead to a risk to health that prompts other regulatory requirements, such as Medical Device Reports, Reports of Corrections and Removals and potentially to premarket requirements where the redesign of cyber security software results in a significant change to a device. There is an open question about whether any correction of software should be reported to the FDA. The webinar will integrate these issues so you can understand the need for cyber security and develop a comprehensive plan to manage the real possibility of a fatal hack attack.Cyber Security issues address software vulnerabilities. Exploiting software vulnerabilities, such as with “hacking,” can lead to devastating results. In terms of medical devices, malicious hacking can lead to serious injury or death. When FDA began to regulate medical devices, software had not evolved to a level of pervasive use, as a standalone device or as a customized platform for institutional use. Areas Covered in the Session :FDA Draft Guidance entitled, “Content of Premarket Submissions for Management of Cyber Security in Medical Devices.”FDA Safety Alert entitled, “Cyber Security for Medical Devices and Hospital Networks: FDA Safety CommunicationDevice regulatory requirements before and after marketingRisk to health consequences of  Cyber Security failureOff-the-Shelf software Cyber SecurityWho Will Benefit:Software specification developers and engineersInformation technology managersRegulatory affairs senior managersRisk managers for clinical institutionsClinical management teamsPatient managers for life supporting/life sustaining devicesCrisis intervention plannersCustomer training managersManufacturers with a history of software recallsDevices Manufacturers that use softwareFDA device consultantsThird party software designers / engineersClinical institutionsEntire staff of a start up device manufacturing firmsPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : 4169154458