Validation of Medical Device Hardware containing Software - How many to Validate

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racglobal

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#1
#1
Hi everyone,

I just want to clarify the concept of validation. If a company manufactures an electromedical device (hardware containing software), how many units of this are we required to validate to show the auditor we can manufacture this device? In the past, a company I worked at arrived at an arbitrary # (e.g. 5 units) and I wasn't sure why. Because of the large scale of the medical equipment, we cannot afford to validate more than a couple. Of all the QMS processes, validation is still the part I am a bit shaky on. Any advice would be appreciated.
 
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Bev D

Bev D

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#2
#2
The sample size isn’t so much about how many units of the device, but how many uses of the device. While software is deterministic, it is dependent on input conditions and these will change from use to use as will the performance of the other electromechanical components. You may be able to validate with only one device if you vary the use conditions. The number of uses can be determined by:
- knowing the acceptable failure rate(s) and using one of the formulas for estimating the failure rate. You would need to know the amount of precision you want in the estimate and the alpha risk and potentially the bet risk. This would typically entail random variation of the use conditions. It does lead to rather large sample sizes tho as low failure rates require larger sample sizes.
- a second approach is to use directed testing under worst case conditions with continuous data response to look for margin. This can substantially reduce your sample size as you don’t have to test all conditions. I use 3-5 ‘uses’ or runs as this gets me a good idea of the extreme of the perfromance range. Of course discussion with your reviewer and/or the reviewing statistician is always good practice. Getting agreement on the study design ahead of time can save a lot of time and frustration...
 
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