Webinar On Cyber Security Planning for Medical Devices

Event Details

Time: February 11, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Jan 16, 2015

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Event Description

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.

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FDA Draft Guidance entitled, “Content of Premarket Submissions for Management of Cyber Security in Medical Devices.”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 Communication

Device regulatory requirements before and after marketing

Risk to health consequences of Cyber Security failure

Off-the-Shelf software Cyber Security

Who Will Benefit:

Software specification developers and engineers

Information technology managers

Regulatory affairs senior managers

Risk managers for clinical institutions

Clinical management teams