SANTA PAULA, Calif.—Applied Silicone Corp. has released material compendia outlining the physical, chemical and biological testing of raw material specific to each long term implantable silicone product the company offers.
The service provides users with a summary of the supporting documentation available for regulatory review and submissions for Class II and Class III medical devices.
Material compendia allow manufacturers to avoid redundant preclinical physical, chemical and bio-compatibility testing of the material for regulatory submissions.