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Auditing and creating checklist for medical device labeling

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Guest user Created:   Apr 14, 2021 Last commented:   Apr 16, 2021

Auditing and creating checklist for medical device labeling

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

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 16, 2021

The best guidance on which elements for medical devices must be on the labels is in section 23.1, 23.2, and 23.3 of the General safety and performance requirements (Annex 1 of the Medical device regulation 2017/745). So, create the checklist according to that and then audit the responsible person for preparing the labels according to all applicable requirements from section 23 of the General safety and performance requirements.

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Apr 14, 2021

Apr 16, 2021