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Medical Device Cyber Security following Latest FDA Guidance

Medical Device Cyber Security following Latest FDA Guidance

Duration: 90 Minutes

Faculty: Edwin Waldbusser      Level: Intermediate      Course ID: 1057


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 with some exceptions established. This webinar will describe a program that will be compliant to the FDA requirements.

Why should you 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 involvement with information sharing groups.

Areas Covered in the Session:

  • Cybersecurity plan
  • Risk based analysis
  • Hazard analysis following ISO14971
  • Risk communication to users
  • Reporting requirements and the exceptions
  • Required membership in information sharing groups

Who Will Benefit:

  • Company Management
  • IT personnel
  • Development Engineers
  • Production Management
  • QA/ QC personnel
  • Software developers

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Regulatory Consultant, Med Device Advisors, Founder, Medical Device SOP Advisors,LLC-offering 82 SOP's