Documenting Software for FDA Submissions 2017
When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rathe...
Inhabited Space: Creating Crime Free Zones
This 2-day course explores principles developed over the last twenty years in the “social behavior” arena. The same concepts that effect positive social engineering are duplicated in designing inhabited spaces to cause people to do what you want them to do. Students will learn to design “from the curb inward” and incorporate overlapping threat prevention principles. We also look at crime and terrorist activity and their...
Flood Control and Storm Water Issues an...
Storm water and flooding comprise major and growing risks to cities, transportation systems, people, and the environment. Flooding has long been the major cause of property damage, and recent catastrophes such as hurricanes Matthew, Sandy and Katrina have exacerbated the total losses and created chain effects in the economy. While storm water control was considered a drainage issue in the past, it has expanded to include regulation under the C...
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