Compliance, medical device software safety

Falls Church, Virginia – Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, presented by FDAnews and GessNet, will be held May 11-12, 2015, in Bethesda, Maryland. 

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 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, 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
  

Attendees can expect to walk away, at the end of two intense days at Software and Cybersecurity Risk Management for Medical Devices, with

• 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

 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
  

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.

Easy ways to register

• Online: http://www.fdanews.com/CybersecurityMDWorkshop 
• By phone: 888-838-5578 or 703-538-7600
• Tuition: $1,797

Source: FDAnews