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Take Back Compliance

The Art of Managing Through Quality

20 things you need to know about SOP for medical devices

20 things you need to know about SOP for medical devices

So, you are a medical device creator and you reached to the point when you see that SOP (Standard Operating Procedure) is required by the FDA, ISO, and other regulatory bodies. But what SOP actually means? By definition, it’s a document that describes the regularly recurring operations relevant to the quality of the investigation. The aim...
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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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