Medical Device Cybersecurity following latest FDA Guidance

Edwin Waldbusser Instructor:
Edwin Waldbusser 
60 Minutes
Webinar ID: 500951

More Trainings by this Expert

Price Details
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


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 devise users.

A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant with the FDA requirements.

Why should you Attend:
Medical device cybersecurity has become very important to the FDA. They have recently issued two Guidance on the subject; the latest is 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.

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 the exceptions

Who Will Benefit:
  • Company Management
  • IT Personnel
  • Development Engineers
  • Production Management
  • QA/ QC Personnel
  • Software Developers
  • Cybersecurity
  • ISAO

Speaker Profile
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

You Recently Viewed

Subscribe to our Newsletter

Subscribe for Compliance Alerts Research Reports Absolutely Free