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"Life Time of a Medical Device"

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Mariah, Dec 9, 2019.

  1. Mariah

    Mariah New Member

    Dec 9, 2019
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    Specifically for our medical device it is implantable and does not come out of the patient. What is considered the life time of the device; that would correlate to the amount of time for record and documentation control. What is the standard practice for this? 10 and 15 years seem to be common numbers thrown around. Let me know your thoughts or send me in the right direction. Thanks for your help in advance.