S11-802: Adventures in Medical Device Testing

Track: Test Environments

Medical device projects are often the stuff of quality assurance mythology. They say that the testing of them requires more rigor than a normal commercial product, and of course we can’t use an exploratory approach. After all, thousands of pages of standards may be involved, heaping crate loads of documentation maybe required, and there’s government oversight; traceability of everything to everything. Yikes!

Last year I plunged into a class III medical device project and discovered that some of these myths have no basis in truth, while others are not quite as advertised. In the process, I discovered a disturbing and interesting thing about the FDA and testing – they don’t actually regulate it. They appear not to care about it. What they want is a demonstration of the product. Attend this session and learn what rapid testing methodology looks like in a regulated context.

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Session Speaker:

James BachJames Bach – Founder, Satisfice, Inc.
James Bach is the Founder of Satisfice, Inc. He started as a programmer but found the problems of software quality analysis and improvement more interesting than those of software production. Today, he works with project teams and individual engineers to help them plan SQA, change control, and testing processes that allow them to understand and control the risks of product failure. He also assists in product risk analysis, test design, and in the design and implementation of computer-supported testing. Most of his experience is with market-driven Silicon Valley software companies like Apple Computer and Borland, so the techniques he has gathered and developed are designed for use under conditions of compressed schedules, high rates of change, component-based technology, and poor specification.