|By PR Newswire||
|April 24, 2014 05:07 PM EDT||
FALLS CHURCH Va., April 24, 2014 /PRNewswire-iReach/ -- Software and Cybersecurity Risk Management for Medical Devices:
Learn Best Practices from FDA and Industry Experts
**Presented by FDAnews and GessNet**
May 21-22, 2014 – Bethesda, MD
This workshop, chaired by internationally renowned expert Fubin Wu and featuring three FDA experts, 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 what the FDA's experts are thinking and how they expect devicemakers to manage the risks of medical devices that contain software.
The instructors will be:
- Fubin Wu, Workshop Leader and Co-Founder of GessNet — 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
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. The seven case studies cover:
1) Best practices and a template for developing a risk traceability matrix
2) Best practices and a template for developing a cybersecurity risk traceability matrix
3) How to convincingly document information in a storytelling fashion for a medical device safety assurance case
4) How to convincingly document information for a medical device cybersecurity assurance case
5) How to apply techniques on identifying and connecting hazards, hazardous situations/causes using device examples
6) How to identify and connect assets, threats and vulnerabilities using device examples
7) How to identify and apply risk controls — and establish traceability of its implementation — using device examples
Spread throughout the course will be lessons in applying these key software risk management related standards and guidances to 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
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 attendees effectively carry out the lessons learned over the two-day conference.
Attendees can expect to walk away with the following 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 devicemakers 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
Software and Cybersecurity Risk Management for Medical Devices:
Learn Best Practices from FDA and Industry Experts
**Presented by FDAnews and GessNet**
May 21-22, 2014 – Bethesda, MD
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
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.
Media Contact: Michelle Butler, FDAnews, 703-538-7665, [email protected]
News distributed by PR Newswire iReach: https://ireach.prnewswire.com
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