Medical device file Vs Role undertaken by the organization

#1
When the role undetaken by the organization A is that of distribution, installation and servicing of the Medical device, and that medical devcie is designed and manufactured by the organization parent company B, which is not covered under the scope of organization A certification., How should the organization A address the requirement a) under the clause 4.2.3 of ISO 13485:2016... (Medical device file) Please share your views
 
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DannyK

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#2
This is what I would write in 4.2.3.
As an organization providing distribution, installation and servicing, the medical device file only includes activities related to these activities for the medical device. The legal manufacturer of the devices is responsible for maintaining the medical device files as per the requirements of ISO 13485:2016 clause 4.2.3.
 
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