On-going stability study requirement for medical device

Parsely

Registered
Our product is a consumable with two years shelf life and it is Class II medical device. I am looking for guidelines for on-going stability study for medical device after the product is launched. Your help is really appreciated.
 

chris1price

Trusted Information Resource
Unlike pharmaceuticals, there is no requirement to perform continued stability studies once a medical device is marketed. You are normally expected to have a minimum of accelerated shelf-life data, followed up with real-time data being generated. This validation is a once-off exercise, unless changes occur.
 
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