🎤  Edwin Waldbusser‎         |  📅  Recording Available   |  🕒  60 Minutes

Areas Covered In The Session:

  • Cybersecurity Plan
  • Risk-based Analysis
  • Hazard Analysis following ISO14971
  • Risk Communication to users
  • Required Membership in information sharing groups
  • Reporting Requirements and Exceptions

Medical devices using the software are similar to other computer software and systems; they can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.  It is essential that companies establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. The cybersecurity program established must be carefully planned and executed.

A formal hazard analysis must be conducted for each risk which must be communicated 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.


Medical device cybersecurity has become a top priority to the FDA. Two guidance’s have been released by the FDA 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.


  • Company Management
  • IT Personnel
  • Development Engineers
  • Production Management
  • QA/ QC Personnel
  • Software Developers
  • Cybersecurity, ISAO, risk
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