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 –...Read More
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...Read More
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,...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.