Stability sampling for Class 1 medical devices

adztesla

Starting to get Involved
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!
 

v9991

Trusted Information Resource
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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