Medical Device Cybersecurity following New FDA Guidance

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
60 minutes
Product Description

Medical Device Cyber Security Program in Compliance with FDA Requirements


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, analyze 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 should attend

  • Engineering Personnel
  • QA
  • Software Developers
  • Management

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About Our Speaker

Edwin Waldbusser

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 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...   More Info
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