Hi Everyone!
Greeting of the day!!
I am new in this forum and looking for solution of my query..
We are the manufacturer of X-Ray based diagnostic medical devices. We have one query regarding Life span of Medical devices. How can we calculate the life of a device?
Let suppose our device life is 10 yrs on the basis of life of critical component but minimum life of one of the critical component is 6 yrs and this part is replaceable if in case get damage. We can change this part at customer end easily and this replacement will not affect the device performance and intended use, Device will work as previously. Due to electronic component it can be damage anytime. Other component life is more than ten years only one or two component have less life but those are replaceable.
Please guide can we consider this or we have to do something else.
Is there anyone have this experience that can explain and help me?
Millions of thanks!
Greeting of the day!!
I am new in this forum and looking for solution of my query..
We are the manufacturer of X-Ray based diagnostic medical devices. We have one query regarding Life span of Medical devices. How can we calculate the life of a device?
Let suppose our device life is 10 yrs on the basis of life of critical component but minimum life of one of the critical component is 6 yrs and this part is replaceable if in case get damage. We can change this part at customer end easily and this replacement will not affect the device performance and intended use, Device will work as previously. Due to electronic component it can be damage anytime. Other component life is more than ten years only one or two component have less life but those are replaceable.
Please guide can we consider this or we have to do something else.
Is there anyone have this experience that can explain and help me?
Millions of thanks!