Sample Size in Design Verification & Process Validation

[MasterBB]

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.

 

[Stijloor]

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.

 

[Juan Dude]

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.

Refer this thread for related discussion: http://elsmar.com/Forums/showthread.php?t=33830