Chemical / Physical Characterization – Information (BA002)
Chemical and Physical Information: Knowledge regarding formulation, manufacturing processes, geometric and physical properties and type of body contact and clinical use that is used to determine whether any additional biological or material characterization testing is needed.
Gathering physical and chemical information on the medical device final finished product and / or its components is the first step in the biological evaluation and associated process of material characterization. The extent of physical and/or chemical characterization information and/or testing required depends on what is known about the material formulation, what nonclinical and clinical safety and toxicological data exist, and on the nature and duration of body contact with the medical device.
NAMSA offers multiple options available in our consulting and laboratory services (including extractables and leachables testing ) to meet the regulatory requirements in this area based on the unique physical and material makeup of the device