Product (Device) Life cycle - Product Life AFTER the Post Market Phase

#1
Hello. I work for a small medical device manufacturer and I am looking for some guidance on "Product Life after the Post Market Phase"

I've see countless papers on the 5 steps product development (most of them good reads) but what can't find much information on is the device life cycle after the Post Market phase.
What are organizations doing to address obsolescence, decommissioning and disposal?
Is this information just becoming part of the risk management file?

I found tons of information posted from companies that would gladly dispose of your devices for you - but next to nothing on how organizations are handling this internally.

I want to tie design controls and 60601-9 together with an end of life plan as a best practice... I just can't find any good information on the topic.
Does anyone have any guidance they can offer on this?
 
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#2
Per ISO 14971, you need to assess risks associated with the device throughout the device life cycle. This includes decommissioning and disposal. The risks associated with decommissioning and disposal are then used as design inputs. These inputs will drive product requirements for labels, instructions for use, or other. The actions taken for end of life vary greatly. Many devices can just be thrown away with minimal associated risk. This is probably why there aren't too many documents on this topic.
 
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