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Take Back Compliance

The Art of Managing Through Quality

20 facts about FDA Approval Process for medical devices

20 facts about FDA Approval Process for medical devices

It is not easy for medical device manufacturers to face that torrent of information that awaits them when they need to face regulatory bodies and launch their device on the market.  Every company that plans to sell its medical device on US ground has to register with the FDA. In the following listing you will read...
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CAPA Checklist - Step by Step Guide

CAPA Checklist - Step by Step Guide

The purpose of corrective and preventive action is to collect and inspect information, identify and examine product or potential quality problem, then take suitable and effective corrective/preventive action.
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ISO 9001 – 2015 Checklist

ISO 9001 – 2015 Checklist

If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following checklist will guide you.
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