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Sample Size in Design Verification & Process Validation
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Sample Size in Design Verification & Process Validation
Sample Size in Design Verification & Process Validation
Sample Size in Design Verification & Process Validation
Sample Size in Design Verification & Process Validation
Sample Size in Design Verification & Process Validation
Sample Size in Design Verification & Process Validation
Sample Size in Design Verification & Process Validation
Sample Size in Design Verification & Process Validation
Sample Size in Design Verification & Process Validation
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  Post Number #1  
Old 15th November 2009, 11:26 PM
MasterBB

 
 
Total Posts: 96
Please Help! Sample Size in Design Verification & Process Validation

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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  Post Number #2  
Old 16th November 2009, 06:45 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,326
Re: Sample Size in Design Verification & Process Validation

Quote:
In Reply to Parent Post by MasterBB View Post

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.
  Post Number #3  
Old 16th November 2009, 09:00 PM
Juan Dude's Avatar
Juan Dude

 
 
Total Posts: 249
Re: Sample Size in Design Verification & Process Validation

Quote:
In Reply to Parent Post by MasterBB View Post

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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