T
Thukira
Hi all
Please suggest me on how to handle the below case;
Two companies they work together and are located in the different place.
The X company produces hardware and the other Y company develops software but can be used in one whole package which is a laboratory use product, not a medical device. Only the Hardware is CE marked/certified where the manufacture is X company and marketing is Y company as per the certification issued.
X company has provided the hardware servicing training to Y company; hence the servicing activities are taken care by the Y company to the products sold by Y company. Y company sell directly to customers (30%) and major through vendors-distributers/dealers etc (70%).
But the QMS scope does not cover servicing activities as of now.
As a whole package of hardware and software are yet to be CE certified. There are some products already in use some countries where there is no regulation as mandate.
From above:
1)Y company QMS should include servicing activities; how to address the liability issues among the X, Y company and also dealers, distributers.
2)Since the hardware is already a CE certified; who will be responsible for Post market issues like recalls, vigilance, FSCA etc. How to handle this, because Y company involves in servicing. And per CE certification X – manufacturer and Y – marketing.
3)Will the maintenance of existing customer base related to MDD requirements of PMS, recall etc also to be considered upon receipt of CE as a package {or} applicable to customer base post CE is received.
4)How the liability can be shared among the X, Y companies and dealers/distributors related to MDD?
5)Is CE is mandate to get as whole package? Or is that fine to have separate CE for software and Hardware? Or how to handle it
6)How to qualify the software for CE mark?
Please help.
Please suggest me on how to handle the below case;
Two companies they work together and are located in the different place.
The X company produces hardware and the other Y company develops software but can be used in one whole package which is a laboratory use product, not a medical device. Only the Hardware is CE marked/certified where the manufacture is X company and marketing is Y company as per the certification issued.
X company has provided the hardware servicing training to Y company; hence the servicing activities are taken care by the Y company to the products sold by Y company. Y company sell directly to customers (30%) and major through vendors-distributers/dealers etc (70%).
But the QMS scope does not cover servicing activities as of now.
As a whole package of hardware and software are yet to be CE certified. There are some products already in use some countries where there is no regulation as mandate.
From above:
1)Y company QMS should include servicing activities; how to address the liability issues among the X, Y company and also dealers, distributers.
2)Since the hardware is already a CE certified; who will be responsible for Post market issues like recalls, vigilance, FSCA etc. How to handle this, because Y company involves in servicing. And per CE certification X – manufacturer and Y – marketing.
3)Will the maintenance of existing customer base related to MDD requirements of PMS, recall etc also to be considered upon receipt of CE as a package {or} applicable to customer base post CE is received.
4)How the liability can be shared among the X, Y companies and dealers/distributors related to MDD?
5)Is CE is mandate to get as whole package? Or is that fine to have separate CE for software and Hardware? Or how to handle it
6)How to qualify the software for CE mark?
Please help.