Quick Start Guide Procedure Pack


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very unusual question : we will commercialise a System/Procedure Pack (article 22 MDR) which is composed of:
- a medical device software installed in an off-the-shelf computer
- other off-the-shelf hardware products.
The hardware products therefore need to be connected (via cables) for the procedure pack to be used (and in fine the medical device software).
In order to facilitate the installation of the procedure pack, we want to add a quick start guide inside the box.
However, the medical device software has warnings/cautions associated to it and they can be found in its eIFU.
my question is thus following -> do we need to add the warnings / cautions of the medical device software inside the Quick Start Guide ? Or the presence of Warning/cautions inside the eIFU is sufficient ?
Thanks for your help !

Ed Panek

QA RA Small Med Dev Company
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Who is the QSG intended to be read by? IT professionals? Lay users? Patients?


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It is meant to be read by Patients and/or healthcare professional (depends on in clinic or at home)


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This is risk-based and should be based on your usability evaluation; do the users in your summative evaluation need the warnings to be in the quick start guide to remain safe?
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