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 and Safety
Security and safety are essentially the same problem, differing
only in the "policy" that must be enforced. The "policy" is like the
requirements specification for any system, specifying what the system is
supposed to do. However, with security and safety, the requirements
specification can not stop there. The system must not only (1) do what it is
supposed to do, but must also (2) NEVER do what it is NOT supposed to do.
The latter, #2, is what makes the design of secure or safe systems so tricky.
It is essentially a negative requirements specification with a huge (if
not infinite) domain.