Medical Device Cyber-Security Following New FDA Guidance

Product Id : FDA34
Instructor : Edwin Waldbusser
Sep 13, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Medical device cybersecurity has become very important for the FDA. They have issued two recent guidance on this subject; the latest being 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.

It is essential for any company to establish a program where they identify, analyse and control cyber security risks. The cyber security program itself needs to be carefully planned.

This webinar by expert speaker Edwin Waldbusser will describe a program that will help you stay compliant with the FDA requirements. Additionally, Edwin will help you in formulating a formal special hazard analysis for every risk, help with strategies with communication of risks; and finally give guidance for a complex set of reporting requirements that have to be established.

Session Highlights:

  • Cybersecurity plan
  • Risk based analysis
  • Hazard analysis following ISO 14971
  • Risk communication to users
  • Required membership in Information Sharing Groups
  • Reporting requirements and the exceptions

Who Will Benefit:

  • Engineering Personnel
  • QA
  • Software Developers
  • Management
Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.

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