Classification of the Reseller of Stand Alone Medical Device Software

[Kuhalit]

Hello, does your notified body also classify the reseller (with distributing / electronic installatio (actually only installer) as a supplier... with all the actions, which are required for supplier

Please tell me your experience.

Best regards
Andreas

 

[c.mitch]

Hi Andreas
I don't know your context but probabilities are high that this reseller is considered as a supplier of a critical service. Critical because a failure of this supplier (eg defect in sw configuration management) may lead to non-conformity of your product (wrong version delivered).

 

[Kuhalit]

Hello, but the supply is only starting with an installer, like MS Office. Is this still critical for you? Of course, if he does customizing... and he mess up something, it might be critical, right?

 

[c.mitch]

If the supplier is just delivering your installer "as is" and the job is done by the end-user, then this (the delivery) doesn't sound critical. He's just a distributor. If he does customization, then yes this sounds critical hence his errors might have severe consequences.