Debugging on site?

[Minnie]

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.

 

[yodon]

Without more details, it's really hard to say; however, it sure sounds like you'd be heading towards a configuration management train wreck.

Is it ok to fix bugs before selling? Absolutely. But it should be done in a controlled manner, through your software design change controls and properly released / archived. Any changes need to be assessed (for risk and) for regulatory impact (i.e., the assessment documented). You need to maintain traceability on what software is installed on what devices.

Is the product CE marked? Otherwise, selling ("making available") would not be a good idea.

 

[Ron Rompen]

My only opinion on this is that it is unethical (at the least....not familiar enough with the standard to state otherwise) to sell a demo unit as 'new'.

 

[Minnie]

Without more details, it's really hard to say; however, it sure sounds like you'd be heading towards a configuration management train wreck.

Is it ok to fix bugs before selling? Absolutely. But it should be done in a controlled manner, through your software design change controls and properly released / archived. Any changes need to be assessed (for risk and) for regulatory impact (i.e., the assessment documented). You need to maintain traceability on what software is installed on what devices.

Is the product CE marked? Otherwise, selling ("making available") would not be a good idea.

Thank you for your comments.

Yes, the product is already CE marked, and the design change is in progress in a controlled manner.

However, since the change process takes time, our marketing also wants to know if we can implement the software update partially on the demo-unit before the change process is finalized, provided that the unit is only used for demonstration purpose and under control of us the legal manufacturer.

Then, they want to update the demo unit with the finalized version before selling to a customer.

I could not find any information to justify or disapprove this.

Thanks

 

[Minnie]

My only opinion on this is that it is unethical (at the least....not familiar enough with the standard to state otherwise) to sell a demo unit as 'new'.

Thank you for your comments.

Personally, I would like to be informed of this demo-use before purchase if I were the customer.

Thanks,

 

[yodon]

Ok, that's better! I don't readily see any issues with what you described, as long as it's clear that the system is a demo and is not being used on / with patients.