Sample Size in Design Verification & Process Validation

MasterBB

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#1
Re: Sample Size...in Medical Devices / Subsystems/Components

What is the best practices used in the Medical Device industry regarding sample size during DV, and PV?

Is it based on Reliability of 99% & Confidence level of 95?

Any published papers/quidelines would be appreciated.

Thanks in advance.
 
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Stijloor

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#2
Re: Sample Size...in Medical Devices / Subsystems/Components

What is the best practices used in the Medical Device industry regarding sample size during DV, and PV?

Is it based on Reliability of 99% & Confidence level of 95?

Any published papers/quidelines would be appreciated.

Thanks in advance.
Bump.

Stijloor.
 
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