L
lindseyc
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
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