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Hi,
I wonder if anyone can help me please? I am new to medical devices that need service and/or repair and just need some clarification on the requirements.
We manufacture and either sell or lease medical devices. Where they are leased, part of that agreement is that we, or our approved supplier, service the equipment in accordance with our instructions (every 6 months). We keep records of all service and maintenance done on the equipment.
Where the device is sold, through a distributor, we have no such agreement, and they are free to choose their own supplier for service. We provide the service manual and requirements for service. At present we do not get copies of the service reports etc. Do we need to?
Thanks
I wonder if anyone can help me please? I am new to medical devices that need service and/or repair and just need some clarification on the requirements.
We manufacture and either sell or lease medical devices. Where they are leased, part of that agreement is that we, or our approved supplier, service the equipment in accordance with our instructions (every 6 months). We keep records of all service and maintenance done on the equipment.
Where the device is sold, through a distributor, we have no such agreement, and they are free to choose their own supplier for service. We provide the service manual and requirements for service. At present we do not get copies of the service reports etc. Do we need to?
Thanks