Medical Device Shelf Life Procedure

The medical device shelf life procedure defines the requirements for establishing a product's shelf life. The document guides the user on stability protocol creation and product characteristics to consider, such as the physical and chemical characteristics of the test device. Biological, toxicological, and material deterioration is also considered in the protocol. The procedure ensures accelerated test calculations and testing performed at predefined test intervals are included in the protocol. The medical device shelf life procedure complies with ISO 11607, ISO 13485, and FDA QSR.