On this week's episode, Rich Thayer and Mickey Urdea are delving into diagnostics regulations with David Kern, detailing the myriad changes in the regulatory landscape since the pandemic in the United States as well as the implications of the new IVDR regulations in Europe. There are few people who can make regulatory as downright enjoyable as Dave Kern; please enjoy his delightful interview.
David Kern is the founder of K2 Regulatory Consulting. With 30+ years of experience in the IVD medical device industry, he has held positions in Product Development, Program Management, Alliance Management, and most recently, Regulatory Affairs. Before starting K2 Regulatory Consulting, he was Head of Regulatory Affairs at Illumina, where he built a global regulatory organization, with offices in China, Australia, and the UK.
Dave has a B.S degree in Biochemistry from San Francisco State University, an MBA from San Jose State University, and holds a RAC from the Regulatory Affairs Professional Society (RAPS). He is also an instructor at UC Santa Cruz Extension.