Device Week Podcast – Episode 11
This article was originally published in The Gray Sheet
Executive Summary
This week, "Gray Sheet" journalists discuss a three-day meeting of the International Organization for Standardization (ISO) to hammer out a final draft of the long-awaited revision of international quality systems standard ISO 13485, two FDA pilot programs to create a transparent device malfunction database and globally harmonized marketing submission system, and new agency requirements when testing stents made with nickel.