STARCANADA 2019 - Compliance
Wednesday, October 23
Safety-Critical Software the Quality Agilist’s Way
Delivering hundreds of laser beams to brain tumors with sub-millimeter precision requires accurate, safe, and effective software that is developed and tested carefully and meticulously. But to be competitive in the market and responsive to customer needs you’ve got to be fast. How do you satisfy this contradiction? How do you know when the software is ready? When is good enough, truly good enough? Are you fast enough, and are you compliant? In two-week sprints, Zap Surgical develops software for planning brain cancer treatments, and then delivering those treatments on its new gyroscopic...
Document Generation for Regulated Industries
PreviewOne of the lines in the Agile Manifesto is "Working software over comprehensive documentation." This doesn't mean that no documentation is produced, but instead that only documentation that brings value to the team and the customer should be created. So what do you do when you are working in a regulated industry and you need to produce extensive documentation to prove that the system works correctly? Jonathan Kauffman recently worked with a company that produces FDA Class II medical devices and wanted to reduce the overhead of creating the documentation required by regulatory...