Hello, we are a legal manufacturer of low risk class medical devices and our subsidiary company in the EU imports and sell the products as the EU-Importer & EU-REP.
The subsidiary has been using one of the products (which is a capital equipment) as a demo unit under control of us manufacturer for a while, and now wants to sell it as a brand new to a customer.
Meanwhile, some bugs are identified in the software which is not a SaMD -but an integrated part of the product.
We want to know if it is OK to update this software on site to reduce bugs before selling.
I am not sure if it is considered as modification of product, servicing activity, or corrective actions.
We know the subsidiary is not supposed to modify the product without appropriate QMS. And we do not consider the bugs an serious incident to report.
I am also wondering if we can sell the product as a brand new.
Any input would be appreciated in order to sell the demo unit without regulatory concerns.
Thanks.
The subsidiary has been using one of the products (which is a capital equipment) as a demo unit under control of us manufacturer for a while, and now wants to sell it as a brand new to a customer.
Meanwhile, some bugs are identified in the software which is not a SaMD -but an integrated part of the product.
We want to know if it is OK to update this software on site to reduce bugs before selling.
I am not sure if it is considered as modification of product, servicing activity, or corrective actions.
We know the subsidiary is not supposed to modify the product without appropriate QMS. And we do not consider the bugs an serious incident to report.
I am also wondering if we can sell the product as a brand new.
Any input would be appreciated in order to sell the demo unit without regulatory concerns.
Thanks.