Designed and implemented the FDA 820.30 Design Control Procedure for RAHD
Oncology Products, integrated with the distributed software development
environment as a cyclic state machine, with a custom developed database driven
web interface and cycle/revision control via CVS. Passed FDA inspection in just
1 day, when 4 had been scheduled. The inspector's only comment was to "keep up
the good work". 2000-2006
Designed a comprehensive methodology for structured software testing, which
addressed the limitations and problems associated with the reliable, ongoing
testing of complex systems, for RAHD Oncology Products. 2000-2002
Extensive research into safety of software and systems, as part of my
Ph.D. research in computer security. 1988-1993
A Note on Security, Safety, and Privacy
Security, safety, and privacy are essentially all the same
problem. They differ only in terms of the policy that must be
enforced. In each, the overall goal is the same, that is, for the
system to do what you want it do do, and never do what you don't want
it to do. The problem then becomes, how to deal with this "negative
requirements specification" -- defining what you do not want to occur,
and then ensuring it. Thus, the same tools and knowledge apply in all
three arenas.