RAQA - Rob Packard-Global Impact-EU MDR-IVDR Changes
This episode is with a gentleman who is no stranger to the show. Rob Packard, the Owner and Founder of Medical Device Academy joined us to discuss the Global impact of the new European MDR and IVDR changes. The Medical Device Academy is a consultancy specializing in 510k submissions and helping medical device and/or drug device organizations with quality and regulatory requirements. Some things Rob covers during the show: -What companies need to focus on first regarding these changes -Which organizations will feel the most impact -Forecast of changes being made to Regulatory & Quality departments -Rob's recommendation on notified bodies ..and much more