Stability sampling for Class 1 medical devices

#1
Hi,

We are planning to do stability study for our Class 2 medical device for identifying the shelf life. We will be doing both accelerated and Realtime aging studies. The shelf life is for an year. How will I be able to find the sampling per time point per testing for both variable and attribute testing?

Many thanks in advance!
 
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#2
Hi,

We are planning to do stability study for our Class 2 medical device for identifying the shelf life. We will be doing both accelerated and Realtime aging studies. The shelf life is for an year. How will I be able to find the sampling per time point per testing for both variable and attribute testing?

Many thanks in advance!
here's one ref.
SHELF LIFE OF MEDICAL DEVICES
https://www.fda.gov/media/72487/download

am not sure, if I am stating obvious., but here's the point. ( based on pharma experience )
1. calculate the number of samples required for testing ( / interval)
2. factor additional samples which will be subjected to testing at each interval ( non-distructive testing)
3. factor the samples for end-of-shelf-life / periodic-testing
4. add the additional samples for any-investigations!
 

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