Hi I wonder if i could have some advice.
I am just working on updating my purchasing and supplier evaluation and risk assessments. I am not sure what category this issue comes in, possibly both. But the question is, if a medical device manufacturer goes bankrupt or ceases trading for whatver reason, and we hold product which we are looking to sell as a distributor, can we sell this? I am concious that there is no manufacturer support for the product if they are no longer around. No post market surveillance would be able to be conducted.
Thanks, Chris
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, you are right. If the manufacturer goes bankrupt and you do not have support for the product, you have to see the risk that something with the medical device went wrong, how can you answer to your client. This means that if you have some simple product that you do not have so far complaints, maybe you can sell this kind of medical device until the certificate expires. However, if your medical device is complex, needs service or installation, or has some complaints where you have to ask for a spare device from the manufacturer, it will be very hard for you to sell that product further on.
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Aug 28, 2023