Hi
This is my first post so I apologise greatly if I have got the wrong forum. (I’ve looked at other forums but can’t seem to find anything very easy to understand….)
I’m looking for some advice on setting up stability trials (shelf life, expiry and usage dates, etc, etc.) The medical device is a
meter and a probe.
One type of probe is built as 20 probes per batch. All the others are built individually.
I need to put together a plan for shelf life studies but not sure how to work out:
- sampling plan for the probes
- acceptance criteria
- confidence limits
- would I perform all the trials on 1 instrument, etc, etc.
I really would appreciate ANY advice AT ALL. (The sensors that we produce are extremely expensive and I’m really worried about not setting up the trial correctly.)
Thanks very much to such a great community!
This is my first post so I apologise greatly if I have got the wrong forum. (I’ve looked at other forums but can’t seem to find anything very easy to understand….)
I’m looking for some advice on setting up stability trials (shelf life, expiry and usage dates, etc, etc.) The medical device is a
meter and a probe.
One type of probe is built as 20 probes per batch. All the others are built individually.
I need to put together a plan for shelf life studies but not sure how to work out:
- sampling plan for the probes
- acceptance criteria
- confidence limits
- would I perform all the trials on 1 instrument, etc, etc.
I really would appreciate ANY advice AT ALL. (The sensors that we produce are extremely expensive and I’m really worried about not setting up the trial correctly.)
Thanks very much to such a great community!