Brian ShoemakerPrincipal Consultant
Brian Shoemaker consults for healthcare products companies in computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S. Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.
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
•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