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Aging rig in medical device industry - To qualify or not
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Aging rig in medical device industry - To qualify or not
Aging rig in medical device industry - To qualify or not
Aging rig in medical device industry - To qualify or not
Aging rig in medical device industry - To qualify or not
Aging rig in medical device industry - To qualify or not
Aging rig in medical device industry - To qualify or not
Aging rig in medical device industry - To qualify or not
Aging rig in medical device industry - To qualify or not
Aging rig in medical device industry - To qualify or not
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Aging rig in medical device industry - To qualify or not


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Some Related Topic Tags
measurement and monitoring and test devices, medical device parts and components, qualification of equipment and processes, validation (general)
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  Post Number #1  
Old 11th October 2017, 04:40 AM
Fylgia

 
 
Total Posts: 3
Question Aging rig in medical device industry - To qualify or not

Hi,
I need some help in my thinking and to do some bench marking.

I'm working with medical device and in R&D we do component verification.
Part of component verification is to do stress tests / aging tests where the components are exposed to cold/heat/chemicals/pressure etc using a purpose built test rig. The rig is built upon calibrated sensors and a control software.

If the test rig would gather any measurements I gladly classify the rig as GxP and thus be subject to qualification (validation) according to our procedures.
However, the rig does not take any measurements or gather any results. It purpose is only to expose the components during a predetermined time.

  1. If you have similar equipment - do you qualify (IQ/OQ) or anything else?
  2. What did you base your decision on for how to treat the rig?
Thank you!

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  Post Number #2  
Old 11th October 2017, 04:47 AM
Ronen E

 
 
Total Posts: 3,514
re: Aging rig in medical device industry - To qualify or not

How can you be sure that the rig did what you intended it to do? I suppose no one sits there to supervise it while it works.
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  Post Number #3  
Old 11th October 2017, 07:43 AM
JJ_FDA

 
 
Total Posts: 24
Re: Aging rig in medical device industry - To qualify or not

I'm with Ronen. You need to qualify it - demonstrate that it does what you think it does.
  Post Number #4  
Old 11th October 2017, 12:49 PM
yodon

 
 
Total Posts: 990
Re: Aging rig in medical device industry - To qualify or not

I'll "third" Ronen's response and agree qualification is needed. You're making quality decisions based on the use of the equipment so you need to have confidence that the equipment is doing what's intended.

Further, since it has control software, the software itself should be validated!
  Post Number #5  
Old 13th October 2017, 04:45 AM
Fylgia

 
 
Total Posts: 3
Re: Aging rig in medical device industry - To qualify or not

Thank you all!

I actually think I can draw a parallel to the use of a climate chamber, which I would always qualify.
The chamber itself do not measure anything on the component, but I want to be sure it works as expected.

(Comment - the people voting for non-qualification will claim that it is not GxP and it can be controlled by calibrating sensors before and after test run to reassure it has performed as expected)

Cheers!
  Post Number #6  
Old 13th October 2017, 08:06 AM
JJ_FDA

 
 
Total Posts: 24
Re: Aging rig in medical device industry - To qualify or not

Quote:
In Reply to Parent Post by Fylgia View Post

the people voting for non-qualification will claim that it is not GxP and it can be controlled by calibrating sensors before and after test run to reassure it has performed as expected
But does that not qualify as a qualification test?
Thanks to JJ_FDA for your informative Post and/or Attachment!
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