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Checklist for medical device labeling including advertising and claims

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Guest user Created:   Jul 12, 2021 Last commented:   Jul 13, 2021

Checklist for medical device labeling including advertising and claims

How to audit and create a checklist for medical device labeling including advertising and claims

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 13, 2021

The best way to prepare the audit checklist is to go through the Annex 1 General safety and performance requirements of the Medical device regulation MDR 2017/745. There in Chapter 3 – Requirements regarding the information supplied with the device you have all requirements that need to be covered in labels and instructions of use

For more information, see:

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Jul 12, 2021

Jul 13, 2021