Then what's the difference in between VALIDATION and VERIFICATION?
So....., here's my simple thoughts,
Is that clinical accuracy should be validated, to get value in a correct way?
There might not be acceptance criteria defined by ISO standards, we only need to meet customer's requirement.
And that laboratory accuracy must be verified, to get the correct value?
There is indeed acceptance criteria defined by ISO standards, we need to follow that.
So....., here's my simple thoughts,
Is that clinical accuracy should be validated, to get value in a correct way?
There might not be acceptance criteria defined by ISO standards, we only need to meet customer's requirement.
And that laboratory accuracy must be verified, to get the correct value?
There is indeed acceptance criteria defined by ISO standards, we need to follow that.
I suggest you read the US FDA's guidance document on design control. I really think this will help you gain a better understanding.
https://www.fda.gov/media/116573/download