S
Hi,
I am making a change to my current medical device and required to perform Design verification and validation.
The change would have an impact on certain parameters say A and B.
Spec Limits A; Max 100 lbs
Spec Limits B; Max 10 grams
How should I proceed with analyzing that my change wouldn’t affect my properties?
I am thinking of doing a 1 sample t test for both A and B. Is there anything else that I would do statistically to prove that the change doesn’t adversely affect my product? Any input is really appreciated.
Thanks.
Note:
The data points are always non-normal, because the measurement system tries to measure a delta value and it’s the best test method available.
I am making a change to my current medical device and required to perform Design verification and validation.
The change would have an impact on certain parameters say A and B.
Spec Limits A; Max 100 lbs
Spec Limits B; Max 10 grams
How should I proceed with analyzing that my change wouldn’t affect my properties?
I am thinking of doing a 1 sample t test for both A and B. Is there anything else that I would do statistically to prove that the change doesn’t adversely affect my product? Any input is really appreciated.
Thanks.
Note:
The data points are always non-normal, because the measurement system tries to measure a delta value and it’s the best test method available.