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Medical Device Stability Testing Requirements

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lindseyc

#1
Hi I m new to medical devices and have a background in pharma.

I would like to have clarification on few requirements for medical devices. So if you can help please do!

If you have an out of specification for medical devices. Do you have to investigate and try assign a route cause and report, an OOS procedure? do ayearly a review for the technical file only? something else?

For stability cabinets is monitoring the temp once a day sufficent or do you need to monitor 24Hrs?

What happens if its out of range so you need an impact assessment?

do you need to temperature map the cabinets yearly or not?

any help is appreciated thanks X
 

edgar123

Starting to get Involved
#2
Hi,

If your device is out of spec, you have to address it through your non conforming product procedure (8.3 of the ISO 13485 standard) and perhaps CAPA (8.5.2/8.5.3) for root cause analysis.

The monitoring of the temperature of the cabinet should be defined in your qualification report for such equipment. You would, of course, have to perform an impact assessment if anything goes wrong.
Then the frequency of the measurement should allow you to take action before the products get shipped out of the factory at least.

The mapping of the cabinet is normally performed during each re-validation when required (that again is defined in the initial validation report).

I guess all this is addressed in details in the pharma GMP but for medical devices it all goes back to risk management and how to control risks and only the expertise of the manufacturer can ensure that.
 
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