Tag

software
In January 2018, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about a potential problem in the charging circuitry of the Zoll LifeVest 4000, which had the potential to prevent it from delivering a life-saving shock to patients. If the message “Call for Service –...
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Came across this website that has some very detailed “commandments” for software development at their company.  A surprisingly lengthy list of dos and don’ts related to coding, testing, designing, estimating, and managing the software lifecycle.  Does your company have anything written?  I often find that each company has some “lore” – some practices that characterize...
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In the July 2006 IEEE Computer Journal article: “The Power of 10: Rules for Developing Safety- Critical Code” by Gerard J. Holzmann of the NASA/JPL Laboratory for Reliable Software, the following 10 rules were listed: Restrict all code to very simple control flow constructs—do not use go to statements, set jump or long jump constructs,...
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62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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