EOL milestone in Medical Devices Regulations

#1
Hi, In SW regulated medical device, within your product lifecycle, how do you define EOL ? and do you distinguish between the EOL date milestone you announce to your customers and users, to the milestone where you have no live systems or customers using the product/version in the field (the time when you can notify the NB on retirement) ?
 
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yodon

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#2
Are you asking about a medical device that contains software or stand-alone software (that is a medical device)? If the former, I don't see that the SW has any bearing on EOL. If the latter (SAMD) then you raise a good question. I think that end of service life would = retirement. If you're not going to support it any more then I would think you'd notify customers of the plan, give them time to transition off, and then pull the plug (all coordinated with the FDA - you posted in the 820 forum).
 
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