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ISO 13485 Update: Deadline Worries For Medtech, Handbook On The Way - And More

This article was originally published in SRA

Executive Summary

Device manufacturers might be tempted to put on the back burner efforts to become certified to the newly published ISO 13485:20161. That's because firms have been given three years by the International Organization for Standardization (ISO) to conform to the rejiggered global quality systems standard.