REGISTRATION IS NOW CLOSED – WORKSHOP IS FULL
Because of the high demand for this workshop we have already reached our maximum capacity. The good news is, it will be held again in the fall. We are just finalizing the dates.
If you would like to be on the waiting list for the May workshop you can register now. We will notify you if there are any cancellations. If there are none we will transfer your registration to the fall workshop or refund your full tuition.
If you would like to be notified when the new dates are confirmed please click below.
Software and Cybersecurity Risk Management for Medical Devices
Learn Best Practices from FDA and Industry Experts
An interactive workshop presented by FDAnews and GessNet
This workshop — chaired by internationally renowned expert Fubin Wu and featuring three FDA experts — has been specifically designed to provide you with industry best practices to assure medical device software safety.
In fact, it's a once-in-a-lifetime opportunity to learn what the FDA’s experts are thinking in terms of best practices to manage the risks of your medical devices that contain software.
Your instructors will be:
- Fubin Wu, Workshop Leader and Co-Founder of GessNet — a software and consulting company specializing in medical device risk management
- Paul Jones, Senior Systems/Software Engineer, Office of Science and Engineering Laboratories, CDRH
- Dr. Lisa Simone, Biomedical Engineer, Office of Science and Engineering Laboratories, Office of Biometrics and Surveillance, CDRH
- Dr. Yi Zhang, Visiting Scientist, Office of Science and Engineering Laboratory, CDRH
- Debra Csore, Consultant with GessNet
In two days of intensive sessions, you 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, you’ll find out more about assurance levels — and best practices to demonstrate safety and cybersecurity — in one of our seven invaluable case studies, always a popular and valuable way to learn. Our seven case studies cover:
Spread throughout the course will be lessons in applying these key software risk management related standards and guidances to your 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 and the FDA’s experts 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
In closing, here's what you can expect to walk away with at the end of two intense days at Software and Cybersecurity Risk Management for Medical Devices:
- An understanding of how medical device manufacturers can overcome both technical and regulatory challenges
- The resources and tools to help you succeed
- The medical device industry’s best practices
- The FDA’s latest updates on medical device software best practices
Sign up NOW for the Waiting List. In fact, bring your entire team (at a discount!) to hear this outstanding faculty of experts who will present, clarify and discuss all the critical issues surrounding this most complicated of issues confronting medical device manufacturers today.
Your Course Materials
Each participant will receive a folder and flash drive packed with tools and reference materials in a combination of both electronic and hard copy format you can put to use right away, including:
- Copies of slides from PowerPoint presentations
- Interactive exercise worksheets
- Copies of case study examples
- Hazard analysis example
- Fault tree analysis example
- Example of FMEA analysis and connectivity with hazard analysis
- Risk traceability matrix example
- Cybersecurity risk analysis example
- Safety assurance case example
- Cybersecurity in Medical Devices (FDA draft guidance, June 2013)
- NIST Framework for Improving Critical Infrastructure Cybersecurity (Version 1.0, 2014)
- Software-Related Recalls: An Analysis of Records (by Lisa K. Simone of FDA, AAMI BI&T Nov/Dec 2013 Issue)
- Reducing Risks and Recalls: Safety Assurance Cases for Medical Devices (by Sherman Eagles and Fubin Wu, AAMI BI&T Jan/Feb 2014 Issue)
- Hazard Analysis for a Generic Insulin Infusion Pump (by Yi Zhang, Paul Jones, and Raoul Jetley of FDA, J Diabetes Sci Technol. Mar 2010)
- Total Product Life Cycle: Infusion Pump (FDA draft guidance, April 2010)
- Radio Frequency Wireless Technology in Medical Devices (FDA guidance, August 2013)
- Mobile Medical Applications (FDA guidance, September 2013)
- Risk Management in the Design of Medical Device Software Systems (by Paul Jones PL, Biomed Instrum Technol 2002 Jul-Aug; 36(4):237-66)