End of Life Programs for Medical Devices

#1
Dear Coves

I work as a Quality Engineer for a class 3 medical device manufacturer. Function include Design, Production, Distribution and Service Post Distribution.

We have a situation where we are expected by management to work cross functionally and prepare an End of Life Program for the device we used to manufacture and distribute 3 years back.

Can some one provide some knowledge on this topic. At least a starting point please ?

QE.:mg:
 
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Michael Malis

Quite Involved in Discussions
#3
Dear Coves

I work as a Quality Engineer for a class 3 medical device manufacturer. Function include Design, Production, Distribution and Service Post Distribution.

We have a situation where we are expected by management to work cross functionally and prepare an End of Life Program for the device we used to manufacture and distribute 3 years back.

Can some one provide some knowledge on this topic. At least a starting point please ?

QE.:mg:
QE - I need some answers before I would be able to provide any useful information.

For starting point, please clarify if your device is disposable or reusable?
My recommendation will very based on this information. You maybe dealing with the piece of equipment or single use device with 2 years of shelf life?
What type of documentation is available? Do you have a complete DHR?

Thanks,
Mike
 
#4
QE - I need some answers before I would be able to provide any useful information.

For starting point, please clarify if your device is disposable or reusable?
My recommendation will very based on this information. You maybe dealing with the piece of equipment or single use device with 2 years of shelf life?
What type of documentation is available? Do you have a complete DHR?

Thanks,
Mike
The device is not a disposable. I would say it is reusable and yes the Devise History Records (Manufacturing, Field corrections and Service Events) are fully and readily available.

Thanks QE.
 
#5
QE - I need some answers before I would be able to provide any useful information.

For starting point, please clarify if your device is disposable or reusable?
My recommendation will very based on this information. You maybe dealing with the piece of equipment or single use device with 2 years of shelf life?
What type of documentation is available? Do you have a complete DHR?

Thanks,
Mike
Hi Michael

The device is not a disposable. It is a reusable device. Any thoughts, knowledge based on that information ?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Can anyone here shed any further light on this? My Thanks in advance!
 

Michael Malis

Quite Involved in Discussions
#8
Last edited:
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