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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.

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