FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15

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The Software and Cybersecurity Risk Management for Medical Device conference — chaired by internationally renowned expert Fubin Wu — has been specifically designed to provide attendees with industry best practices to achieve compliance and effectively assure medical device software safety. In two days of intensive sessions, attendees will be brought up to date on the FDA’s latest research on medical device software best practices, software risk management related standards and guidances and key success factors for effective software risk management.

Software and Cybersecurity Risk Management for Medical Devices:
Understanding the FDA’s Position and Best Practices for Compliance
**Presented by FDAnews and GessNet**
Oct. 14-15, 2015 – Rockville, MD
http://www.fdanews.com/cybersecuritymd

This workshop, chaired by internationally renowned expert Fubin Wu, has been specifically designed to provide devicemakers with industry best practices to achieve compliance and effectively assure medical device software safety.

In fact, it's a once-in-a-lifetime opportunity to learn how the FDA expects devicemakers to manage the risks of medical devices that contain software.

The workshop instructors will be:

  •     Fubin Wu, Workshop Leader and Co-Founder of GessNet — software and consulting company specializing in medical device risk management
  •     Dr. Lisa Simone, Software Review Team Lead and Policy Advisor, Office of Blood Research and Review, CBER, FDA

In two days of intensive sessions, attendees will be brought up to date on the FDA’s latest guidances on medical device software best practices, software risk management related standards and guidances and key success factors for effective software risk management.

Plus, in a special bonus, attendees will find out more about assurance levels — and what it will take to convince regulators — in four class exercises, always a popular and valuable way to learn. Our four class exercises cover:

  •     risk analysis for medical device mobile apps
  •     risk assessments and risk controls for software hazards
  •     cybersecurity risk analysis
  •     cybersecurity risk assessments and risk controls

During each teaching session, Mr. Wu, and Dr. Simone will share techniques and best practices on how to:

  •     identify software related risks
  •     identify, assess and manage safety risks
  •     perform cybersecurity risk analysis (assets, threats, vulnerabilitites, security risk assessments and controls)
  •     document medical device safety and cybersecurity risk analysis for stakeholders (internal reviewers, FDA reviewers, hospital, etc.)
  •     build assurance cases demonstrating device safety and cybersecurity

In closing, here's what attendees can expect to walk away with at the end of two intense days at Software and Cybersecurity Risk Management for Medical Devices:

  •     Understanding of how medical device manufacturers can overcome both technical and regulatory compliance challenges
  •     The resources and tools to help manufacturers succeed
  •     The medical device industry’s best practices
  •     The FDA’s latest updates on medical device software best practices

Who Will Benefit:

  •     Software systems design engineers and managers
  •     Quality, reliability and risk management engineers and managers
  •     Project managers involved in design and development
  •     Medical staff evaluating risk, safety or effectiveness
  •     Quality managers
  •     Regulatory affairs specialists and managers
  •     Medical device app developers
  •     IT systems development managers
  •     Contract manufacturers
  •     General/corporate counsel

Meet the Instructors:

Fubin Wu, Co-Founder, GessNet
Fubin Wu is the Co-Founder of GessNet. GessNet is a software and consulting company specializing in medical device risk management. He designed and led the development of TurboAC™ risk management and assurance case software, in concert with the FDA, Association for the Advancement of Medical Instrumentation (AAMI), medical device manufacturers, hospitals and industry experts. Mr. Wu has spent more than 16 years in medical device quality management systems, hardware/software reliability engineering and risk management, serving various roles from quality engineer to quality director.

Lisa Simone, Ph.D., Software Review Team Lead and Policy Advisor, Office of Blood Research and Review, CBER, FDA
Lisa Simone works for the FDA as Software Engineering Team Lead and Policy Advisor in the Office of Blood and Research and Review in the Center for Biologics Evaluation and Research (CBER). In this role she leads the software group in review of devices including blood donor screening tests, retroviral diagnostic tests, and software used to test, collect, process, or store donated blood. Dr. Simone also leads the development and review of policy for software in regulated devices.

Conference Details:
Software and Cybersecurity Risk Management for Medical Devices:
Understanding the FDA’s Position and Best Practices for Compliance
**Presented by FDAnews and GessNet**
Oct. 14-15, 2015 – Rockville, MD
http://www.fdanews.com/cybersecuritymd

Tuition: $1,797

Easy Ways to Register:
Online:     http://www.fdanews.com/cybersecuritymd
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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