Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview

November 15, 2019

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Foolproof Investigations: A Proven Approach for Root Cause Analysis in a Regulated Environment
Foolproof Investigations: A Proven Approach for Root Cause Analysis in a Regulated Environment

Over the last couple of years, we have seen a significant increase in warning letters and consent decrees t...

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The Value of Studying and Utilizing FDA's QSIT Manual
The Value of Studying and Utilizing FDA's QSIT Manual

The FDA’s approach to the inspection process of medical device manufacturers, Quality System Inspection Tec...