Medical Device Cybersecurity Following Latest FDA Guidance

This webinar will describe a program that will be compliant with the FDA requirements. The FDA expects a proactive and extensive risk-based program to minimize risk to the user from cyber-attacks including active involvement with information sharing groups.

Edwin Waldbusser
Instructor:
Edwin Waldbusser
Date:
Tuesday, March 10, 2020
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502939

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
$289 $340 Live + Recorded
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$599 $680 Corporate
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Overview:

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. This webinar will describe a program that will be compliant to the FDA requirements

Why you should 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 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 Exceptions

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


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.


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