Medical Devices

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Final Guidance (Webinar) – October 29, 2014

   

Webinar: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Final Guidance

Summary: The final guidance identifies issues related to cybersecurity that manufacturers should consider in the design and development of medical devices and in preparing premarket submissions.

The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, and the frequent electronic exchange of medical device-related health information.

This guidance applies to premarket medical device submissions received beginning October 1, 2014.

Target Audience: Medical Device Industry, Medical Device Industry Associations, Health care Professional Associations, Patient Associations 

Page Last Updated: 11/08/2016
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