Physico-chemical controls on Medical Device

A medical device, or a material used in a medical device, that comes into direct contact with patients must be able to perform its intended function without inducing significant rejection.

The chemical analysis of a medical device generally includes a wide range of tests and product evaluations, such as:

• Morphological characterization of materials
• Assays and residual tests
• Degradation products
• Ethylene oxide and related degradation products determination
• Storage and stability studies
• Extractables & Leachables studies
• Material characterization 
• Nanomaterials identification and characterization