EAS Webinar: FDA’s Transition from CFR 820 to the ISO 13485:2016 - Instituting a New Quality Management System (QMS) September 25, 2019 Presented by George Yanulis, D.Eng., EAS Independent Consultant FDA’s shift to a to a Quality System Regulation structure of ISO 13485:2016 is an effort to harmonize medical device regulations as well as reduce compliance and record keeping burdens faced by current medical device manufacturers. But will those operating under 21 CFR 820 Quality Management Systems made the voluntary switch? While ISO 13485 is an international standard, its focus on design

Statistics show that nearly 40,000 people died on American roads in 2016, and the National Highway Traffic Administration says 94% of those fatal car accidents were attributed to human error. Logic says eliminate the human from the equation and there will be far fewer accidents, right? https://www.montgomeryfirm.com/car-accidents/

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In a broadcast report concerning Plaintiff (P), CBS dramatized reports about P's conduct acting as court-appointed conservator of an elderly woman. When P sued CBS for defamation, CBS defended on Anti-SLAPP grounds. California Court of Appeals for the Third District held that Anti-SLAPP did not apply because: (1) as a Court-appointed conservator P is a “public official”, and (2) as a public official, P had to prove that CBS published defamatory statements about her with “actual malice” which P has not done. Judgment reversed.

Justice Stevens retired from the U.S. Supreme Court in 2010, after serving at the High Court for 35 years. Justice Stevens was born April 20, 1920 in Chicago, Illinois. In 1941, he earned his bachelor of arts in English from the University of Chicago. Soon thereafter, he enlisted in the U.S. Navy, where he served as an intelligence officer from 1942 to 1945, and was awarded a Bronze Star for his service. He later attended Northwestern Univeristy School of Law from where he obtained his juris doctorate degree in 1947 magna cum laude. After finishing law school, Stevens clerked for Justice Wile

Loyola Law School, Los Angeles, was ranked seventh in 2012 Princeton Review's Best 167 Law Schools for “Best Professors”.

U.S. News & World Report’s 2012 edition of “America’s Best Graduate Schools" ranks Loyola Law School Los Angeles as 54 among the 190 American Bar Association-accredited law schools. Loyola Law School's tax progam is ranked 10th nationwide.