Brian Shoemaker
Principal Consultant
ShoeBar Associates
Check out the incredible speaker line-up to see who will be joining Brian .
Download The Latest AgendaPRE-CONFERENCE WORKSHOP DAY
Monday, January 22nd, 2018
1:30 PM WORKSHOP B: AN INCREMENTAL APPROACH TO RISK AND QUALITY MANAGEMENT IN MEDICAL DEVICE SOFTWARE DESIGN
Software Engineers are dedicated to making things work, so a focus on failure can be unusual. However, risk management is essential for all medical devices, especially those involving software. There are many examples that software failures have produced some painful examples of poor risk management with serious consequences.
· Understand “Safety Hazards” related to software
· Evaluate the intersection of medical device standards and their intersection with risk management
· Assess End users and Human Factors to improve safety
· Apply engineering risk methods to software design concepts
· Draw a roadmap for effective risk management
MAIN CONFERENCE DAY TWO
Wednesday, January 24th, 2018
11:15 AM REVISIT AGILE ADOPTION FOR REGULATED MEDICAL SOFTWARE?
•Experience that both quality and safety are improved when the software development team is agile, and that regulatory requirements can still be met
•Delve into several key areas for applying Agile methods in the medical device context
•Fit together hardware and software development, and being Agile in both