FDAnews New Workshop — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, April 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

Software and Cybersecurity Risk Management for Medical Devices

“[I liked the] Small discussion groups and intimate setting.” — May 2014 Workshop Participant

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

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

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.

Plus, in a special bonus, attendees will find out more about assurance levels and what it will take to convince regulators in one of seven invaluable case studies, always a popular and valuable way to learn.

Spread throughout the course will be lessons in applying these key software risk management related standards and guidances to the software development processes:

  •     ISO 14971:2007 and EN ISO 14971:2012, IEC 62304 Medical Device Life Cycle Process, IEC TR 80002-1 Application of ISO 14971 for Software
  •     FDA Guidance on Mobile Medical Applications, Cybersecurity in Medical Devices, Infusion Pump Total Product Life Cycle

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

  •     identify software related risks
  •     identify software risk control and mitigation measures
  •     assess and evaluate risk contributed/caused by software (premarket and post-market field issues)
  •     assure the completeness and adequacy of risk management
  •     communicate risk management information throughout the life of the product
  •     key success factors for effective software risk management

Special Take-Home Resource Kit:
Attendees will take home a jam-packed resource kit with more than 20 templates, checklists, case studies, guidances and supporting information. These are the tools that will help to effectively carry out the lessons learned over the two-day conference.

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 Instructor:
Fubin Wu is the Co-Founder of GessNet. GessNet is a software and consulting company specializing in medical device risk management (http://www.GessNet.com). 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.

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**
April 14-15, 2015 – Bethesda, MD
http://www.fdanews.com/SoftwareAndCybersecurity

Tuition: $1,797

Easy Ways to Register:
Online:     http://www.fdanews.com/SoftwareAndCybersecurity
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
+1 (703) 538-7665
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