PRODUCT VALIDATION AND STABILITY STUDIES

Life expectancy and storage conditions of medical devices.


* Process and product validation.
* Performance evaluation of the finished product.
* Biocompatibility testing, according to ISO 10993.
* In-vivo testing.
* Clinical testing.
* Accelerated and long-term stability studies, according to ASTM F-1980-07 regulations.
* Sterilization Validation Services in compliance with ISO 11135 and ISO 10993 standards.


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