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Medical Device Design Verification and Validation - info

S

sriram_govi

#1
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.
 
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M

MIREGMGR

#2
You're asking what seems like a vague question about an extremely broad subject. Maybe you could be more specific?

Beyond that, validation ultimately needs to show that the device is safe and effective. Going directly to a determination that particular parameters haven't changed, without additionally and more importantly showing that safety and effectiveness are assuredly correlated to those parameters, would not be adequate.
 
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