Device Week, 12 June 2020 – New Insights Into FDA’s Quality System Reg Rewrite

On this week’s podcast we discuss some recent news out of the US FDA about its efforts to harmonize its Quality System Regulation with international quality systems standard ISO 13485. Medtech Insight articles addressing topics discussed in this episode: Q&A: New Details Emerge From FDA About Long-Delayed Draft Rule That Harmonizes Quality System Reg With ISO 13485 For FDA, The Third Time Wasn’t The Charm For Releasing A Draft Of Its Harmonized Quality System Reg FDA’s Retooled Quality System Regulation Coming ‘Sometime This Year,’ CDRH Chief Shuren Says