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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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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:
- EU MDR Annex 1 – General safety and performance requirements https://advisera.com/13485academy/mdr/general-requirements/
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Jul 12, 2021
Jul 13, 2021
Jul 13, 2021